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出境医 / 临床实验 / Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State (TMScogMod)

Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State (TMScogMod)

Study Description
Brief Summary:

The purpose of this study is to improve understanding of the way transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation, affects the brain. The study hypothesis that when theta burst stimulation (TBS) is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. This study will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated frontoparietal network (FPN), which subserves cognitive control - the ability to flexibly adapt and regulate behavior, an ability known to be impaired in neuropsychiatric conditions such as depression and dementia.

Healthy volunteers that qualify for this study will have psychological assessments and cognitive measures, as well as functional Magnetic Resonance Imaging (fMRI) scans, completed after administration of TMS. Participants will be asked to come in for a total of five visits that include; a screening and assessment visit; a baseline functional magnetic resonance imaging (fMRI) scan, followed by TMS session; Visits 3, 4, and 5 will be the experimental TMS session, followed by fMRI scan.


Condition or disease Intervention/treatment Phase
Healthy Device: TMS Behavioral: n-back working memory task Not Applicable

Detailed Description:
Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: All participants will have 3 MRI sessions subsequent to the baseline visit and these will occur in a counterbalanced order.
Masking: Single (Participant)
Masking Description: All subjects will receive all interventions in a cross-over design. The three intervention sessions (visits 3, 4 & 5) will be given in counter-balanced order, stratified by gender. Subjects will be blind to the nature of the questions being asked; however, they will be told that different stimulation paradigms will be used, which will be evident to the subjects as they go through the procedures.
Primary Purpose: Basic Science
Official Title: Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State
Actual Study Start Date : November 11, 2019
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: TMS to dlPFC, without a concurrent task
TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are in a resting state
 Device: TMS
Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
Other Name: intermittent theta burst stimulation (iTBS)

Behavioral: n-back working memory task
Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (2 letters or 1 letter)
Experimental: TMS to vertex, without concurrent task
TMS (intermittent theta burst stimulation) will be applied to the cerebral vertex, when subjects are in a resting state
 Device: TMS
Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
Other Name: intermittent theta burst stimulation (iTBS)

Behavioral: n-back working memory task
Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (2 letters or 1 letter)
Experimental: TMS to dlPFC, during task
TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are engaged in the n-back working memory task
 Device: TMS
Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
Other Name: intermittent theta burst stimulation (iTBS)

Behavioral: n-back working memory task
Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (2 letters or 1 letter)
Outcome Measures
Primary Outcome Measures :
  1. 2-back minus 1-back Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (2-back) versus low (1-back) loads.

  2. FPN connectivity to dlPFC TBS stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Resting-state connectivity of low frequency BOLD fluctuations for a seed at the dlPFC

  3. rCBF at stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured at the site of TBS stimulation

  4. Accuracy to 2-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Correct responses to letter stimuli, as a percentage of all responses


Secondary Outcome Measures :
  1. 3-back minus 1-back BOLD activation, voxelwise in whole brain [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (3-back) versus low (1-back) loads.

  2. Measure cerebral blood flow (rCBF) in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured in the FPN

  3. Median Reaction Time (RT) to 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Median reaction time for subjects responding in the n-back task, for correct responses

  4. d-prime in 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    d-prime measure, including all hits, misses, false alarms and 'correct rejections'


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of child bearing age can not be pregnant or trying to become pregnant
  • Ability to tolerate small, enclosed spaces without anxiety
  • Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly
  • Ability and willingness to give informed consent to participate
  • Alcohol or drug dependence (if in remission for greater than 5 years)

Exclusion Criteria

  • History of past or current mental illness (except simple phobias)
  • History of closed head injury, for example, loss of consciousness > approximately 5 minutes, hospitalization, neurological sequela;
  • Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (for example; aneurysm clips, retained particles or metal workers with exposures, neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, and automatic implantable defibrillators).
  • Prescription or non-prescription, with psychotropic effects (birth control medications allowed)
  • First-degree family members with a history of epilepsy
  • History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Pan Gu 734-936-4958 TMScogMod-study@med.umich.edu
Contact: Laura Stchur, MSW 734-936-1323 lmarine@med.umich.edu

Locations
Layout table for location information
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48170
Contact: Laura Stchur, MSW    734-936-1323    lmarine@med.umich.edu   
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Stephan Taylor, MD University of Michigan
Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE November 11, 2019
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2021)
  • 2-back minus 1-back Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (2-back) versus low (1-back) loads.
  • FPN connectivity to dlPFC TBS stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Resting-state connectivity of low frequency BOLD fluctuations for a seed at the dlPFC
  • rCBF at stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured at the site of TBS stimulation
  • Accuracy to 2-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Correct responses to letter stimuli, as a percentage of all responses
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • 3-back minus 1-back Blood Oxygen Level-Dependent (BOLD) activation, voxelwise in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (3-back) versus low (1-back) loads.
  • FPN connectivity to dlPFC TBS stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Resting-state connectivity of low frequency BOLD fluctuations for a seed at the dlPFC
  • rCBF at stimulation target [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured at the site of TBS stimulation
  • Accuracy to 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Correct responses to letter stimuli, as a percentage of all responses
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • 3-back minus 1-back BOLD activation, voxelwise in whole brain [ Time Frame: 60 minutes after TMS during fMRI ]
    Fronto-parietal network defined by BOLD change while subject performs the n-back working memory task, contrasting high (3-back) versus low (1-back) loads.
  • Measure cerebral blood flow (rCBF) in FPN [ Time Frame: 60 minutes after TMS during fMRI ]
    Regional cerebral blood flow measured in the FPN
  • Median Reaction Time (RT) to 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    Median reaction time for subjects responding in the n-back task, for correct responses
  • d-prime in 3-back [ Time Frame: 60 minutes after TMS during fMRI ]
    d-prime measure, including all hits, misses, false alarms and 'correct rejections'
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 Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State
Official Title  ICMJE Theta Burst Transcranial Magnetic Stimulation of Fronto-parietal Networks: Modulation by Mental State
Brief Summary

The purpose of this study is to improve understanding of the way transcranial magnetic stimulation (TMS), a form of non-invasive brain stimulation, affects the brain. The study hypothesis that when theta burst stimulation (TBS) is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. This study will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated frontoparietal network (FPN), which subserves cognitive control - the ability to flexibly adapt and regulate behavior, an ability known to be impaired in neuropsychiatric conditions such as depression and dementia.

Healthy volunteers that qualify for this study will have psychological assessments and cognitive measures, as well as functional Magnetic Resonance Imaging (fMRI) scans, completed after administration of TMS. Participants will be asked to come in for a total of five visits that include; a screening and assessment visit; a baseline functional magnetic resonance imaging (fMRI) scan, followed by TMS session; Visits 3, 4, and 5 will be the experimental TMS session, followed by fMRI scan.
Detailed Description Please note the collaborator (NIMH) is requesting that an NCT number be obtained prior to receiving the award.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
All participants will have 3 MRI sessions subsequent to the baseline visit and these will occur in a counterbalanced order.
Masking: Single (Participant)
Masking Description:
All subjects will receive all interventions in a cross-over design. The three intervention sessions (visits 3, 4 & 5) will be given in counter-balanced order, stratified by gender. Subjects will be blind to the nature of the questions being asked; however, they will be told that different stimulation paradigms will be used, which will be evident to the subjects as they go through the procedures.
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Device: TMS
    Intermittent theta burst stimulation TMS applied to the cortex to excite cerebral cortex
    Other Name: intermittent theta burst stimulation (iTBS)
  • Behavioral: n-back working memory task
    Subjects perform an executive function task, in which they view the serial presentation of letters and decide whether or not a letter matches a letter presented 'n' letters back (2 letters or 1 letter)
Study Arms  ICMJE
  • Experimental: TMS to dlPFC, without a concurrent task
    TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are in a resting state
    Interventions:
    • Device: TMS
    • Behavioral: n-back working memory task
  • Experimental: TMS to vertex, without concurrent task
    TMS (intermittent theta burst stimulation) will be applied to the cerebral vertex, when subjects are in a resting state
    Interventions:
    • Device: TMS
    • Behavioral: n-back working memory task
  • Experimental: TMS to dlPFC, during task
    TMS (intermittent theta burst stimulation) will be applied to the dlPFC, when subjects are engaged in the n-back working memory task
    Interventions:
    • Device: TMS
    • Behavioral: n-back working memory task
Publications * Taylor SF, Lee TG, Jonides J, Tso IF, Hernandez-Garcia L. Theta Burst Transcranial Magnetic Stimulation of Fronto-Parietal Networks: Modulation by Mental State. J Psychiatr Brain Sci. 2020;5. pii: e200011. doi: 10.20900/jpbs.20200011. Epub 2020 May 26.

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 3, 2019) 		48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women of child bearing age can not be pregnant or trying to become pregnant
  • Ability to tolerate small, enclosed spaces without anxiety
  • Size compatible with scanner gantry, e. g. men over 6 feet tall that weigh more than 250 lbs, men under 6 feet tall that weigh over 220 lbs, women over 5'11" tall that weigh more than 220 lbs, or women under 5'10" tall that weigh more than 200 lbs. Subjects of these weights or greater typically have difficult fitting into the fMRI scanner properly
  • Ability and willingness to give informed consent to participate
  • Alcohol or drug dependence (if in remission for greater than 5 years)

Exclusion Criteria

  • History of past or current mental illness (except simple phobias)
  • History of closed head injury, for example, loss of consciousness > approximately 5 minutes, hospitalization, neurological sequela;
  • Metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (for example; aneurysm clips, retained particles or metal workers with exposures, neurostimulators, foil-backed transdermal patches, carotid or cerebral stents, cerebral spinal fluid (CSF) shunts; magnetic dental implants, ferromagnetic ocular implants, pacemakers, and automatic implantable defibrillators).
  • Prescription or non-prescription, with psychotropic effects (birth control medications allowed)
  • First-degree family members with a history of epilepsy
  • History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pan Gu 734-936-4958 TMScogMod-study@med.umich.edu
Contact: Laura Stchur, MSW 734-936-1323 lmarine@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04010461
Other Study ID Numbers  ICMJE HUM00165239
R21MH120633-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

The PI will share information about this/these trial(s) via timely registration, updates, and results reporting in ClinicalTrials.gov in accordance with NIH policy.

The PI will also upload data gathered in this proposal to an National Institute of Mental Health (NIMH)-designated central data, NIMH Data Archive (NDA), as prescribed by NOT-MH-15-012, working with NIMH program to determine the timing and extent of data sharing. This includes formulation of an enrollment strategy that will obtain the information necessary to generate a Global Unique Identifier (GUID) for each participant.

The consent form will include language indicating the intention to upload de-identified data into the central archive, and permission will be obtained from University of Michigan Institutional Review Board to do so. The budget includes a data manager to cover the costs of managing the data, building the data dictionary and harmonizing it with data structures.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: De-identified data will be entered into the NDA within 1 year of the conclusion of the study.
Access Criteria: No additional access restrictions will be placed on the de-identified data beyond those that are standard for the NDA.
URL: https://nda.nih.gov
Responsible Party Stephan F. Taylor, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Stephan Taylor, MD University of Michigan
PRS Account University of Michigan
Verification Date June 2021

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

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