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出境医 / 临床实验 / Accelerated Theta Burst in Chronic Pain: A Biomarker Study

Accelerated Theta Burst in Chronic Pain: A Biomarker Study

Study Description
Brief Summary:
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Intermittent Theta Burst Stimulation (iTBS) Not Applicable

Detailed Description:
Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, randomized control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Accelerated Theta Burst in Chronic Pain: A Biomarker Study
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023
Arms and Interventions
Arm Intervention/treatment
Active Comparator: iTBS over L-DLPFC to dACC

Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the dorsal anterior cingulate cortex (dACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.

Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

 Device: Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Other Names:
  • Accelerated Theta Burst Stimulation (aTBS)
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
Active Comparator: iTBS over L-DLPFC to sgACC

Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the subgenual cingulate cortex (sgACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.

Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

 Device: Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Other Names:
  • Accelerated Theta Burst Stimulation (aTBS)
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
Sham Comparator: Sham iTBS over L-DLPFC

Participants will receive sham iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system.

Sham stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

 Device: Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Other Names:
  • Accelerated Theta Burst Stimulation (aTBS)
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
Outcome Measures
Primary Outcome Measures :
  1. Change in the Brief Pain Inventory (BPI) score [ Time Frame: Pre-treatment, immediately post-treatment ]

    A self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of depression and individual is experiencing.

    Scoring:

    1. Pain Severity Score: This is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10.
    2. Pain Interference Score: This is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.

  2. Change in the McGill Pain Questionnaire score [ Time Frame: Pre-treatment, immediately post-treatment ]
    A self-report questionnaire that allows individuals that assesses the quality and intensity of pain that is experienced. The pain rating index has 2 subscales: sensory subscale with 11 words, and affective subscale with 4 words. These items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain.


Secondary Outcome Measures :
  1. Change in the Montgomery Asberg Depression Rating Scale (MADRS) score [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]

    A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.

    Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60; 0 to 6 - normal, symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.


  2. Change in teh Hamilton Rating Scale for Depression (HAM-17) score [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A provider administered questionnaire used to assess remission and recovery from depression. in general the higher the total score the more severe the depression. HAM-D score level of depression: 10-13 mild; 14-17 mild to moderate; >17 moderate to severe.

  3. Change in the Pain Catastrophizing Scale (PCS) score [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52 that measures a person's catastrophizing of pain. A higher score indicates a higher level of pain catastrophizing.

  4. Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Pre-treatment, immediately post-treatment, 4 weeks post-treatment ]
    Participants will have fMRI scans both before the first treatment (baseline) and after the aiTBS course. The MRI scans will be used to identify potential biomarkers for antidepressant response and pain response, as well as identify aiTBS-induced changes in functional connectivity.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
  2. Age 18 - 70
  3. Right-handed
  4. Agree to having fMRI scans as well as rTMS sessions
  5. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
  6. Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
  7. Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. Antidepressant must be of the SSRI class only (if currently on a different antidepressant, patients will be switched to an SSRI). They must maintain that same antidepressant regimen throughout the study duration.

Exclusion Criteria:

  1. History of MI, CABG, CHF, or other cardiac history.
  2. Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
  3. Pregnancy or breastfeeding
  4. Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
  5. Autism spectrum disorder
  6. Inability to stop taking medication contraindicated with treatment
  7. Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
  8. A positive urine toxicology screen
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Katy Stimpson, BS 650-736-2233 kstimpson@stanford.edu
Contact: James Bishop, PhD 650-736-2233 jhbishop@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University
Palo Alto, California, United States, 94304
Contact: Katy Stimpson    650-736-2233    kstimpson@stanford.edu   
Contact: James Bishop, PhD    650-736-2233    jhbishop@stanford.edu   
Sponsors and Collaborators
Stanford University
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date March 17, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change in the Brief Pain Inventory (BPI) score [ Time Frame: Pre-treatment, immediately post-treatment ]
    A self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of depression and individual is experiencing. Scoring:
    1. Pain Severity Score: This is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10.
    2. Pain Interference Score: This is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
  • Change in the McGill Pain Questionnaire score [ Time Frame: Pre-treatment, immediately post-treatment ]
    A self-report questionnaire that allows individuals that assesses the quality and intensity of pain that is experienced. The pain rating index has 2 subscales: sensory subscale with 11 words, and affective subscale with 4 words. These items are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate and 3 = severe. There's also one item for present pain intensity and one item for a 10cm visual analogue scale for average pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2019)
  • Change in the Montgomery Asberg Depression Rating Scale (MADRS) score [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60; 0 to 6 - normal, symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.
  • Change in teh Hamilton Rating Scale for Depression (HAM-17) score [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A provider administered questionnaire used to assess remission and recovery from depression. in general the higher the total score the more severe the depression. HAM-D score level of depression: 10-13 mild; 14-17 mild to moderate; >17 moderate to severe.
  • Change in the Pain Catastrophizing Scale (PCS) score [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A self-report measure, consisting of 13 items scored from 0 to 4, resulting in a total possible score of 52 that measures a person's catastrophizing of pain. A higher score indicates a higher level of pain catastrophizing.
  • Change in functional connectivity as measured by Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Pre-treatment, immediately post-treatment, 4 weeks post-treatment ]
    Participants will have fMRI scans both before the first treatment (baseline) and after the aiTBS course. The MRI scans will be used to identify potential biomarkers for antidepressant response and pain response, as well as identify aiTBS-induced changes in functional connectivity.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Accelerated Theta Burst in Chronic Pain: A Biomarker Study
Official Title  ICMJE Accelerated Theta Burst in Chronic Pain: A Biomarker Study
Brief Summary This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.
Detailed Description Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Blinded, randomized control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE Device: Intermittent Theta Burst Stimulation (iTBS)
Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
Other Names:
  • Accelerated Theta Burst Stimulation (aTBS)
  • Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Arms  ICMJE
  • Active Comparator: iTBS over L-DLPFC to dACC

    Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the dorsal anterior cingulate cortex (dACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.

    Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

    Intervention: Device: Intermittent Theta Burst Stimulation (iTBS)
  • Active Comparator: iTBS over L-DLPFC to sgACC

    Participants will receive iTBS (intermittent theta burst stimulation) to the left dorsal lateral prefrontal cortex (L-DLPFC) with high connectivity to the subgenual cingulate cortex (sgACC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.

    Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

    Intervention: Device: Intermittent Theta Burst Stimulation (iTBS)
  • Sham Comparator: Sham iTBS over L-DLPFC

    Participants will receive sham iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system.

    Sham stimulation will be delivered to L-DLPFC using the MagPRo stimulator.

    Intervention: Device: Intermittent Theta Burst Stimulation (iTBS)
Publications *
  • Avery DH, Zarkowski P, Krashin D, Rho WK, Wajdik C, Joesch JM, Haynor DR, Buchwald D, Roy-Byrne P. Transcranial magnetic stimulation in the treatment of chronic widespread pain: a randomized controlled study. J ECT. 2015 Mar;31(1):57-66. doi: 10.1097/YCT.0000000000000125.
  • Baeken C, Marinazzo D, Everaert H, Wu GR, Van Hove C, Audenaert K, Goethals I, De Vos F, Peremans K, De Raedt R. The Impact of Accelerated HF-rTMS on the Subgenual Anterior Cingulate Cortex in Refractory Unipolar Major Depression: Insights From 18FDG PET Brain Imaging. Brain Stimul. 2015 Jul-Aug;8(4):808-15. doi: 10.1016/j.brs.2015.01.415. Epub 2015 Feb 7.
  • Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26. Erratum in: Lancet. 2018 Jun 23;391(10139):e24.
  • Bonelli RM, Cummings JL. Frontal-subcortical circuitry and behavior. Dialogues Clin Neurosci. 2007;9(2):141-51. Review.
  • Borckardt JJ, Nahas Z, Koola J, George MS. Estimating resting motor thresholds in transcranial magnetic stimulation research and practice: a computer simulation evaluation of best methods. J ECT. 2006 Sep;22(3):169-75.
  • Cieslik EC, Zilles K, Caspers S, Roski C, Kellermann TS, Jakobs O, Langner R, Laird AR, Fox PT, Eickhoff SB. Is there "one" DLPFC in cognitive action control? Evidence for heterogeneity from co-activation-based parcellation. Cereb Cortex. 2013 Nov;23(11):2677-89. doi: 10.1093/cercor/bhs256. Epub 2012 Aug 23.
  • Connolly KR, Helmer A, Cristancho MA, Cristancho P, O'Reardon JP. Effectiveness of transcranial magnetic stimulation in clinical practice post-FDA approval in the United States: results observed with the first 100 consecutive cases of depression at an academic medical center. J Clin Psychiatry. 2012 Apr;73(4):e567-73. doi: 10.4088/JCP.11m07413.
  • Duprat R, Desmyter S, Rudi de R, van Heeringen K, Van den Abbeele D, Tandt H, Bakic J, Pourtois G, Dedoncker J, Vervaet M, Van Autreve S, Lemmens GM, Baeken C. Accelerated intermittent theta burst stimulation treatment in medication-resistant major depression: A fast road to remission? J Affect Disord. 2016 Aug;200:6-14. doi: 10.1016/j.jad.2016.04.015. Epub 2016 Apr 19.
  • Gamboa OL, Antal A, Moliadze V, Paulus W. Simply longer is not better: reversal of theta burst after-effect with prolonged stimulation. Exp Brain Res. 2010 Jul;204(2):181-7. doi: 10.1007/s00221-010-2293-4. Epub 2010 Jun 22.
  • George MS, Ketter TA, Parekh PI, Rosinsky N, Ring H, Casey BJ, Trimble MR, Horwitz B, Herscovitch P, Post RM. Regional brain activity when selecting a response despite interference: An H2 (15) O PET study of the stroop and an emotional stroop. Hum Brain Mapp. 1994;1(3):194-209. doi: 10.1002/hbm.460010305.
  • George MS, Lisanby SH, Avery D, McDonald WM, Durkalski V, Pavlicova M, Anderson B, Nahas Z, Bulow P, Zarkowski P, Holtzheimer PE 3rd, Schwartz T, Sackeim HA. Daily left prefrontal transcranial magnetic stimulation therapy for major depressive disorder: a sham-controlled randomized trial. Arch Gen Psychiatry. 2010 May;67(5):507-16. doi: 10.1001/archgenpsychiatry.2010.46.
  • George MS, Taylor JJ, Short EB. The expanding evidence base for rTMS treatment of depression. Curr Opin Psychiatry. 2013 Jan;26(1):13-8. doi: 10.1097/YCO.0b013e32835ab46d. Review.
  • Grimm S, Beck J, Schuepbach D, Hell D, Boesiger P, Bermpohl F, Niehaus L, Boeker H, Northoff G. Imbalance between left and right dorsolateral prefrontal cortex in major depression is linked to negative emotional judgment: an fMRI study in severe major depressive disorder. Biol Psychiatry. 2008 Feb 15;63(4):369-76. Epub 2007 Sep 21.
  • Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6.
  • Kreuzer PM, Schecklmann M, Lehner A, Wetter TC, Poeppl TB, Rupprecht R, de Ridder D, Landgrebe M, Langguth B. The ACDC pilot trial: targeting the anterior cingulate by double cone coil rTMS for the treatment of depression. Brain Stimul. 2015 Mar-Apr;8(2):240-6. doi: 10.1016/j.brs.2014.11.014. Epub 2014 Nov 29.
  • Lan MJ, Chhetry BT, Liston C, Mann JJ, Dubin M. Transcranial Magnetic Stimulation of Left Dorsolateral Prefrontal Cortex Induces Brain Morphological Changes in Regions Associated with a Treatment Resistant Major Depressive Episode: An Exploratory Analysis. Brain Stimul. 2016 Jul-Aug;9(4):577-83. doi: 10.1016/j.brs.2016.02.011. Epub 2016 Mar 2.
  • Larson J, Munkácsy E. Theta-burst LTP. Brain Res. 2015 Sep 24;1621:38-50. doi: 10.1016/j.brainres.2014.10.034. Epub 2014 Oct 27. Review.
  • Lee SJ, Kim DY, Chun MH, Kim YG. The effect of repetitive transcranial magnetic stimulation on fibromyalgia: a randomized sham-controlled trial with 1-mo follow-up. Am J Phys Med Rehabil. 2012 Dec;91(12):1077-85. doi: 10.1097/PHM.0b013e3182745a04.
  • Lefaucheur JP. The use of repetitive transcranial magnetic stimulation (rTMS) in chronic neuropathic pain. Neurophysiol Clin. 2006 May-Jun;36(3):117-24. Epub 2006 Aug 23. Review.
  • Li CT, Chen MH, Juan CH, Huang HH, Chen LF, Hsieh JC, Tu PC, Bai YM, Tsai SJ, Lee YC, Su TP. Efficacy of prefrontal theta-burst stimulation in refractory depression: a randomized sham-controlled study. Brain. 2014 Jul;137(Pt 7):2088-98. doi: 10.1093/brain/awu109. Epub 2014 May 10.
  • Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f. Review.
  • Ochsner, K. N., & Gross, J. J. (2005). Putting the ' I ' and the ' Me ' in emotion regulation : Reply to Northoff, (xx), 6613. https://doi.org/10.1016/j.tics.2005.06.005
  • Ohayon MM. Specific characteristics of the pain/depression association in the general population. J Clin Psychiatry. 2004;65 Suppl 12:5-9.
  • Onghena P, Van Houdenhove B. Antidepressant-induced analgesia in chronic non-malignant pain: a meta-analysis of 39 placebo-controlled studies. Pain. 1992 May;49(2):205-219. doi: 10.1016/0304-3959(92)90144-Z.
  • Smolen P, Zhang Y, Byrne JH. The right time to learn: mechanisms and optimization of spaced learning. Nat Rev Neurosci. 2016 Feb;17(2):77-88. doi: 10.1038/nrn.2015.18. Review.
  • Taylor JJ, Borckardt JJ, Canterberry M, Li X, Hanlon CA, Brown TR, George MS. Naloxone-reversible modulation of pain circuitry by left prefrontal rTMS. Neuropsychopharmacology. 2013 Jun;38(7):1189-97. doi: 10.1038/npp.2013.13. Epub 2013 Jan 11.
  • Taylor JJ, Borckardt JJ, George MS. Endogenous opioids mediate left dorsolateral prefrontal cortex rTMS-induced analgesia. Pain. 2012 Jun;153(6):1219-1225. doi: 10.1016/j.pain.2012.02.030. Epub 2012 Mar 22.
  • Tendler A, Roth Y, Barnea-Ygael N, Zangen A. How to Use the H1 Deep Transcranial Magnetic Stimulation Coil for Conditions Other than Depression. J Vis Exp. 2017 Jan 23;(119). doi: 10.3791/55100.
  • Vanneste S, Ost J, Langguth B, De Ridder D. TMS by double-cone coil prefrontal stimulation for medication resistant chronic depression: a case report. Neurocase. 2014;20(1):61-8. doi: 10.1080/13554794.2012.732086. Epub 2012 Oct 11.
  • Williams NR, Sudheimer KD, Bentzley BS, Pannu J, Stimpson KH, Duvio D, Cherian K, Hawkins J, Scherrer KH, Vyssoki B, DeSouza D, Raj KS, Keller J, Schatzberg AF. High-dose spaced theta-burst TMS as a rapid-acting antidepressant in highly refractory depression. Brain. 2018 Mar 1;141(3):e18. doi: 10.1093/brain/awx379.
  • Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB, Yunus MB. The American College of Rheumatology preliminary diagnostic criteria for fibromyalgia and measurement of symptom severity. Arthritis Care Res (Hoboken). 2010 May;62(5):600-10. doi: 10.1002/acr.20140.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
  2. Age 18 - 70
  3. Right-handed
  4. Agree to having fMRI scans as well as rTMS sessions
  5. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
  6. Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
  7. Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. Antidepressant must be of the SSRI class only (if currently on a different antidepressant, patients will be switched to an SSRI). They must maintain that same antidepressant regimen throughout the study duration.

Exclusion Criteria:

  1. History of MI, CABG, CHF, or other cardiac history.
  2. Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
  3. Pregnancy or breastfeeding
  4. Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
  5. Autism spectrum disorder
  6. Inability to stop taking medication contraindicated with treatment
  7. Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
  8. A positive urine toxicology screen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katy Stimpson, BS 650-736-2233 kstimpson@stanford.edu
Contact: James Bishop, PhD 650-736-2233 jhbishop@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984201
Other Study ID Numbers  ICMJE 48366
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nolan R, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stanford University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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