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

October 19, 2023 updated by: Jon Houck, The Mind Research Network

Cerebellar Repetitive Transcranial Magnetic Stimulation (rTMS) for Reduction of Negative Affect and Treatment of Alcohol Use Disorder

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jon M Houck, PhD
  • Phone Number: 505-272-5028
  • Email: jhouck@mrn.org

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • The Mind Research Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cerebellar rTMS
Cerebellar rTMS. 1Hz repetitive transcranial magnetic stimulation (rTMS) to cerebellar vermis.
Device: Repetitive transcranial magnetic stimulation (rTMS)
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.
Sham Comparator: Sham TMS
Sham TMS. Sham transcranial magnetic stimulation to cerebellar vermis.
Device: Sham transcranial magnetic stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to drinking relapse as measured by the Time Line Follow Back
Time Frame: 8 weeks
Time to drinking relapse as measured by the Time Line Follow Back from baseline in days.
8 weeks
Change in percent days abstinent as measured by the Time Line Follow Back
Time Frame: 3 weeks
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).
3 weeks
Change in self reported negative affect as measured by the Promise anger, anxiety and depression scales
Time Frame: 2 weeks
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).
2 weeks
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
Time Frame: 2 weeks
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.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Mind Research Network

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Jon M Houck, PhD, The Mind Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2019

Primary Completion (Actual)

September 7, 2023

Study Completion (Actual)

September 7, 2023

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

February 1, 2019

First Posted (Actual)

February 4, 2019

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 19, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14918 (Helse Vest IKT)
  • R21AA026573 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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