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Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation (rTMS)
Sham transcranial magnetic stimulation
Sponsored by
The Mind Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring rTMS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year;
  • Interested in cutting down or quitting drinking;
  • Able to provide voluntary informed consent;
  • Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days;
  • Currently receiving treatment for alcohol use disorder.

Exclusion Criteria:

  • Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses);
  • Other urgent medical problems, as determined by the study physician from the history and physical exam;
  • Schizophrenia, schizoaffective disorder, bipolar I disorder
  • Suicidal thoughts (intent or plan) in the last month;
  • Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month;
  • Active legal problems with the potential to result in incarceration;
  • Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed);
  • Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization);
  • Have previously undergone rTMS (to assure the blind is effective);
  • Personal or familial (in first degree relatives) history of epilepsy;
  • Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.

Sites / Locations

  • The Mind Research Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Cerebellar rTMS

Sham TMS

Arm Description

Cerebellar rTMS. 1Hz repetitive transcranial magnetic stimulation (rTMS) to cerebellar vermis.

Sham TMS. Sham transcranial magnetic stimulation to cerebellar vermis.

Outcomes

Primary Outcome Measures

Time to drinking relapse as measured by the Time Line Follow Back
Time to drinking relapse as measured by the Time Line Follow Back from baseline in days.
Change in percent days abstinent as measured by the Time Line Follow Back
Change in percent days abstinent as measured by the Time Line Follow Back from the 90 days prior to day 1 to day 14-21 (post-treatment).
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scale T scores from baseline to day 15 (post-treatment).
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI from baseline to day 15 (post-treatment). This will be calculated using a mask derived from preliminary data from a sample of 33 individuals with AUD at a single timepoint. Activation in this brain region was correlated with depression, anxiety, and recent drinking. Manuscript describing this result is under review (Wilcox et al.), and another manuscript describes the task in question (Wilcox et al. 2014 Cognitive Control Network Function in Alcohol Use Disorder Before and During Treatment With Lorazepam. Subst Use Misuse.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2018
Last Updated
October 19, 2023
Sponsor
The Mind Research Network
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03829761
Brief Title
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder
Official Title
Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for Reduction of Negative Affect and Treatment of Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
September 7, 2023 (Actual)
Study Completion Date
September 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Mind Research Network
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of the current study is to investigate the effects of repetitive transcranial magnetic stimulation (rTMS) on self-reported negative affect, cerebellar brain activation and alcohol use outcomes in alcohol use disorder (AUD).
Detailed Description
To achieve study aims, 34 treatment seeking adults with AUD will be recruited from local intensive outpatient (IOP) treatment programs and randomized to treatment with either inhibitory 1Hz rTMS to cerebellar vermis given daily for 2 weeks (total of 10 sessions) or sham. Alcohol use outcomes, self-reported negative affect, and craving will be obtained at baseline, 1 day, 1 week and 6 weeks following rTMS termination. An fMRI scan during a Stroop task will be obtained at baseline and 1 day after the final rTMS session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
rTMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cerebellar rTMS
Arm Type
Experimental
Arm Description
Cerebellar rTMS. 1Hz repetitive transcranial magnetic stimulation (rTMS) to cerebellar vermis.
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
Sham TMS. Sham transcranial magnetic stimulation to cerebellar vermis.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation (rTMS)
Intervention Description
Repetitive transcranial magnetic stimulation (rTMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of 1Hz stimulation, for a total of 1800 pulses delivered.
Intervention Type
Device
Intervention Name(s)
Sham transcranial magnetic stimulation
Intervention Description
Sham transcranial magnetic stimulation (TMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of sham stimulation. Sham stimulation will imitate the active rTMS but does not have active stimulation.
Primary Outcome Measure Information:
Title
Time to drinking relapse as measured by the Time Line Follow Back
Description
Time to drinking relapse as measured by the Time Line Follow Back from baseline in days.
Time Frame
8 weeks
Title
Change in percent days abstinent as measured by the Time Line Follow Back
Description
Change in percent days abstinent as measured by the Time Line Follow Back from the 90 days prior to day 1 to day 14-21 (post-treatment).
Time Frame
3 weeks
Title
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales
Description
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scale T scores from baseline to day 15 (post-treatment).
Time Frame
2 weeks
Title
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI
Description
Change in cerebellar brain activation as indicated by percent signal change in the medial cerebellum during incongruent minus congruent trials during a multisensory Stroop task during fMRI from baseline to day 15 (post-treatment). This will be calculated using a mask derived from preliminary data from a sample of 33 individuals with AUD at a single timepoint. Activation in this brain region was correlated with depression, anxiety, and recent drinking. Manuscript describing this result is under review (Wilcox et al.), and another manuscript describes the task in question (Wilcox et al. 2014 Cognitive Control Network Function in Alcohol Use Disorder Before and During Treatment With Lorazepam. Subst Use Misuse.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females age 18-65 meeting DSM-V criteria for moderate or severe AUD in the past year; Interested in cutting down or quitting drinking; Able to provide voluntary informed consent; Have at least 4 heavy drinking days (≥ 5 drinks per day for men, and ≥4 for women) in the past 60 days; Currently receiving treatment for alcohol use disorder. Exclusion Criteria: Severe neurological conditions (TBI/stroke/history of a seizure/dementia and other significant cognitive illnesses); Other urgent medical problems, as determined by the study physician from the history and physical exam; Schizophrenia, schizoaffective disorder, bipolar I disorder Suicidal thoughts (intent or plan) in the last month; Current moderate or severe other SUD (except nicotine or marijuana) or other drug (except nicotine or marijuana) use in the past month; Active legal problems with the potential to result in incarceration; Pregnancy or lactation, or child bearing age and sexually active but not on birth control (barrier methods allowed); Current daily use of anti-craving medications, antidepressants (at doses considered therapeutic for depression), benzodiazepines, antipsychotics (at doses considered therapeutic for psychosis or mood stabilization), mood stabilizers (at doses considered therapeutic for mood stabilization); Have previously undergone rTMS (to assure the blind is effective); Personal or familial (in first degree relatives) history of epilepsy; Any contraindication for Magnetic Resonance Imaging (MRI) or TMS including metal shards or certain implants (pacemakers etc.) in the body.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon M Houck, PhD
Organizational Affiliation
The Mind Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Mind Research Network
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Alcohol Use Disorder

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