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出境医 / 临床实验 / Pilot rTMS for AUD+mTBI (TMS_AUD+mTBI)

Pilot rTMS for AUD+mTBI (TMS_AUD+mTBI)

Study Description
Brief Summary:
This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Mild Traumatic Brain Injury Post-traumatic Stress Disorder Device: repetitive transcranial magnetic stimulation Phase 2

Detailed Description:
Mild traumatic brain injury (mTBI), post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are high priority disorders for the Department of Veterans Affairs (VA), in part, because these disorders rarely occur in isolation. The co-occurrence compounds brain impairment and negatively impacts symptom presentation and rehabilitation effectiveness. Veterans with co-occurring AUD, mTBI and/or PTSD have few effective treatment options. Thus, treatment development for these Veterans is of great need. The aim of this protocol is to examine safety, feasibility, and the behavioral and neural effects of an repetitive transcranial magnetic stimulation (rTMS) intervention for Veterans with AUD and co-occurring mTBI and/or PTSD. Behavioral and neural effects of rTMS will be examined after the first rTMS session and after the last rTMS session. The investigators hypothesize that the rTMS intervention will be 1) safe, 2) feasible and 3) efficacious. Specifically, the investigators hypothesize that there will be no adverse events related to the rTMS intervention. The investigators hypothesize that all participants enrolled will successfully complete all rTMS sessions. The investigators hypothesize that participants treated with active rTMS, relative to placebo rTMS, will have reduced alcohol craving severity levels. Finally, the investigators hypothesize that participants treated with active rTMS relative to placebo rTMS will have reduced brain activation in response to alcohol cues and improved functional connectivity after the last rTMS session. This is a prospective, pilot, double-blind randomized controlled trial of the intervention rTMS. There will be 2 groups of Veterans with AUD and co-occurring mTBI and/or PTSD those given 1) active rTMS and those given 2) placebo rTMS. Targeted enrollment for this study is 20 Veterans: n=10 active rTMS and n=10 placebo rTMS. Participants will be screened for safety and evaluated on mental health-related behavioral measures. Eligible participants will be randomized to receive active or placebo rTMS. Participants will then complete motor thresholding (MT) to determine rTMS intensity. Participants will then complete 10 sessions of rTMS. These sessions will be completed once daily on week days over two weeks. TMS pulses will be applied to the left DLPFC at 10Hz rate, 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. After the 10th rTMS session, participants will complete an MRI which will last approximately 1hour. A sub-sample of participants will complete an MRI immediately after the first rTMS session. Participants will also repeat the mental health behavioral measures after the last rTMS session. Participants will complete follow-up phone interviews to assess for alcohol craving, mTBI symptoms and PTSD symptoms at one day, one week and one month post-rTMS. Completion of this study is an essential first step towards treatment development for Veterans with co-occurring AUD, mTBI and/or PTSD.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blind, randomized controlled trial of two parallel groups: active and placebo rTMS
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: A unblinded member(s) of the research team will be provided with randomization codes from the study biostatistician. A unblended research team member will then provide the PI and rTMS treatment providers with a specific code for the rTMS device. rTMS providers enter the specific rTMS code into the rTMS device and the device is designed to deliver active or placebo rTMS based on this code. The rTMS device is designed to deliver placebo rTMS that looks, sounds and feels like active rTMS.
Primary Purpose: Treatment
Official Title: Brain Targets for Alcohol Craving in Veterans With mTBI.
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021
Arms and Interventions
Arm Intervention/treatment
Active Comparator: active
active rTMS
 Device: repetitive transcranial magnetic stimulation
rTMS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P). The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.
Other Name: transcranial magnetic stimulation
Placebo Comparator: placebo
placebo rTMS
 Device: repetitive transcranial magnetic stimulation
rTMS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P). The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.
Other Name: transcranial magnetic stimulation
Outcome Measures
Primary Outcome Measures :
  1. Penn Alcohol Craving Scale Change [ Time Frame: baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up ]
    5-item self-report measure of alcohol craving and each item is scored on a scale of 0 to 6. The minimum total score is 0 and the maximum is 30, indicating less to more severe alcohol craving, respectively.

  2. Total Adverse Event Frequency [ Time Frame: immediately after last/10th rTMS session - up to 2 weeks ]
    An adverse event log will be kept for each participant and each rTMS treatment session. After each treatment these events will be recorded and the total frequency of events will be used as the outcome after all 10 rTMS sessions over the course of the 2 week treatment have been completed.

  3. Total rTMS Sessions Completed [ Time Frame: after the 10th and last rTMS treatment session - up to 2 weeks ]
    Total number of rTMS treatment sessions completed out of 10 sessions. After all 10 rTMS sessions over the course of the 2 week treatment this cumulative total number of sessions complete can be computed.


Eligibility Criteria
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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • English Speaking
  • Veterans
  • Ages 22 through 65
  • Meeting AUDIT-C criteria for AUD (4 for men and 3 for women)
  • Pass MRI screening using the Center for Translational Imaging (CTI) Safety Form.
  • Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) scores of 10

Exclusion Criteria:

  • History of moderate to severe TBI
  • Documented and verified history of psychotic spectrum disorders (i.e., schizophrenia, bipolar)
  • Receipt of anti-epileptic medications to control active seizures or evidence of documented seizure within past six months
  • Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold

  • Current use of:

    • opiates
    • cocaine
    • amphetamines
    • barbiturates
    • benzodiazepine
    • marijuana/cannabis dependence as determined by the SCID-IV

  • Currently prescribed any anti-craving/addiction medications, i.e.:

    • naltrexone
    • varenicline
    • bupropion
    • disulfiram
    • acamprosate
  • Meet questionable validity or malingering criteria on the Minnesota Multiphasic Personality Inventory-2-RF (MMPI-2-RF; F: T score 107; F(p): T score 85; TRIN: T score 80; VRIN: T score 80) or the Letter Memory Test (LMT; total score 92%), as determined in IRB#13-077
  • Pregnant or nursing
  • Have congestive heart failure

  • Have cardiac pacemaker or defibrillator, or:

    • cochlear implant
    • nerve stimulator
    • intracranial metal clips
    • implanted medical pump
    • increased intracranial pressure

  • History of:

    • surgery on blood vessels in brain and/or valves of the heart
    • brain hemorrhage
    • neurovascular conditions
    • neurodegenerative disorders
    • claustrophobia
    • metal in eye/face
    • shrapnel/bullet remnants in brain
  • Actively suicidal as evidenced by plan to harm or recent attempt communicated on the BDI-II or electronic medical record within the past 6 months
  • History of mild TBI within the last 3 months
Contacts and Locations

Locations
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United States, Illinois
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Amy A Herrold, PhD BA Edward Hines Jr. VA Hospital, Hines, IL
Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE June 21, 2019
Last Update Posted Date November 25, 2020
Actual Study Start Date  ICMJE March 21, 2019
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2019)
  • Penn Alcohol Craving Scale Change [ Time Frame: baseline, immediately after last/10th rTMS session, and 1 day, 1 week, and 1 month follow-up ]
    5-item self-report measure of alcohol craving and each item is scored on a scale of 0 to 6. The minimum total score is 0 and the maximum is 30, indicating less to more severe alcohol craving, respectively.
  • Total Adverse Event Frequency [ Time Frame: immediately after last/10th rTMS session - up to 2 weeks ]
    An adverse event log will be kept for each participant and each rTMS treatment session. After each treatment these events will be recorded and the total frequency of events will be used as the outcome after all 10 rTMS sessions over the course of the 2 week treatment have been completed.
  • Total rTMS Sessions Completed [ Time Frame: after the 10th and last rTMS treatment session - up to 2 weeks ]
    Total number of rTMS treatment sessions completed out of 10 sessions. After all 10 rTMS sessions over the course of the 2 week treatment this cumulative total number of sessions complete can be computed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot rTMS for AUD+mTBI
Official Title  ICMJE Brain Targets for Alcohol Craving in Veterans With mTBI.
Brief Summary This is a pilot randomized controlled trial (RCT) for Veteran participants with alcohol use disorder co-occurring with mild traumatic brain injury and/or post-traumatic stress disorder. The treatment intervention is repetitive Transcranial Magnetic Stimulation (rTMS) and the goal is to reduce alcohol craving with this treatment. The study will enroll 20 Veteran participants. Half of these participants will receive real rTMS and half of the participants will receive placebo rTMS. rTMS treatment will be provided over 10 sessions that will occur once every weekday for 2 weeks. Veteran participants will then complete follow-up phone calls to further evaluate alcohol craving and other symptoms.
Detailed Description Mild traumatic brain injury (mTBI), post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) are high priority disorders for the Department of Veterans Affairs (VA), in part, because these disorders rarely occur in isolation. The co-occurrence compounds brain impairment and negatively impacts symptom presentation and rehabilitation effectiveness. Veterans with co-occurring AUD, mTBI and/or PTSD have few effective treatment options. Thus, treatment development for these Veterans is of great need. The aim of this protocol is to examine safety, feasibility, and the behavioral and neural effects of an repetitive transcranial magnetic stimulation (rTMS) intervention for Veterans with AUD and co-occurring mTBI and/or PTSD. Behavioral and neural effects of rTMS will be examined after the first rTMS session and after the last rTMS session. The investigators hypothesize that the rTMS intervention will be 1) safe, 2) feasible and 3) efficacious. Specifically, the investigators hypothesize that there will be no adverse events related to the rTMS intervention. The investigators hypothesize that all participants enrolled will successfully complete all rTMS sessions. The investigators hypothesize that participants treated with active rTMS, relative to placebo rTMS, will have reduced alcohol craving severity levels. Finally, the investigators hypothesize that participants treated with active rTMS relative to placebo rTMS will have reduced brain activation in response to alcohol cues and improved functional connectivity after the last rTMS session. This is a prospective, pilot, double-blind randomized controlled trial of the intervention rTMS. There will be 2 groups of Veterans with AUD and co-occurring mTBI and/or PTSD those given 1) active rTMS and those given 2) placebo rTMS. Targeted enrollment for this study is 20 Veterans: n=10 active rTMS and n=10 placebo rTMS. Participants will be screened for safety and evaluated on mental health-related behavioral measures. Eligible participants will be randomized to receive active or placebo rTMS. Participants will then complete motor thresholding (MT) to determine rTMS intensity. Participants will then complete 10 sessions of rTMS. These sessions will be completed once daily on week days over two weeks. TMS pulses will be applied to the left DLPFC at 10Hz rate, 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. After the 10th rTMS session, participants will complete an MRI which will last approximately 1hour. A sub-sample of participants will complete an MRI immediately after the first rTMS session. Participants will also repeat the mental health behavioral measures after the last rTMS session. Participants will complete follow-up phone interviews to assess for alcohol craving, mTBI symptoms and PTSD symptoms at one day, one week and one month post-rTMS. Completion of this study is an essential first step towards treatment development for Veterans with co-occurring AUD, mTBI and/or PTSD.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double-blind, randomized controlled trial of two parallel groups: active and placebo rTMS
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
A unblinded member(s) of the research team will be provided with randomization codes from the study biostatistician. A unblended research team member will then provide the PI and rTMS treatment providers with a specific code for the rTMS device. rTMS providers enter the specific rTMS code into the rTMS device and the device is designed to deliver active or placebo rTMS based on this code. The rTMS device is designed to deliver placebo rTMS that looks, sounds and feels like active rTMS.
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Use Disorder
  • Mild Traumatic Brain Injury
  • Post-traumatic Stress Disorder
Intervention  ICMJE Device: repetitive transcranial magnetic stimulation
rTMS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P). The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.
Other Name: transcranial magnetic stimulation
Study Arms  ICMJE
  • Active Comparator: active
    active rTMS
    Intervention: Device: repetitive transcranial magnetic stimulation
  • Placebo Comparator: placebo
    placebo rTMS
    Intervention: Device: repetitive transcranial magnetic stimulation
Publications * Not Provided

*   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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2021
Estimated Primary Completion Date November 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English Speaking
  • Veterans
  • Ages 22 through 65
  • Meeting AUDIT-C criteria for AUD (4 for men and 3 for women)
  • Pass MRI screening using the Center for Translational Imaging (CTI) Safety Form.
  • Clinical Institute of Withdrawal Assessment in Alcohol Withdrawal (CIWA-Ar) scores of 10

Exclusion Criteria:

  • History of moderate to severe TBI
  • Documented and verified history of psychotic spectrum disorders (i.e., schizophrenia, bipolar)
  • Receipt of anti-epileptic medications to control active seizures or evidence of documented seizure within past six months
  • Receipt of tricyclic anti-depressants, antipsychotic agents, or other drugs that lower the seizure threshold

  • Current use of:

    • opiates
    • cocaine
    • amphetamines
    • barbiturates
    • benzodiazepine
    • marijuana/cannabis dependence as determined by the SCID-IV

  • Currently prescribed any anti-craving/addiction medications, i.e.:

    • naltrexone
    • varenicline
    • bupropion
    • disulfiram
    • acamprosate
  • Meet questionable validity or malingering criteria on the Minnesota Multiphasic Personality Inventory-2-RF (MMPI-2-RF; F: T score 107; F(p): T score 85; TRIN: T score 80; VRIN: T score 80) or the Letter Memory Test (LMT; total score 92%), as determined in IRB#13-077
  • Pregnant or nursing
  • Have congestive heart failure

  • Have cardiac pacemaker or defibrillator, or:

    • cochlear implant
    • nerve stimulator
    • intracranial metal clips
    • implanted medical pump
    • increased intracranial pressure

  • History of:

    • surgery on blood vessels in brain and/or valves of the heart
    • brain hemorrhage
    • neurovascular conditions
    • neurodegenerative disorders
    • claustrophobia
    • metal in eye/face
    • shrapnel/bullet remnants in brain
  • Actively suicidal as evidenced by plan to harm or recent attempt communicated on the BDI-II or electronic medical record within the past 6 months
  • History of mild TBI within the last 3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995173
Other Study ID Numbers  ICMJE B0949-W
IK2RX000949 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
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 VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy A Herrold, PhD BA Edward Hines Jr. VA Hospital, Hines, IL
PRS Account VA Office of Research and Development
Verification Date November 2020

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

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