Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Active dTMS
Sham dTMS
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse
Eligibility Criteria
Inclusion Criteria:
- Age 18 - 65
- Current diagnosis of alcohol dependence
- Alcohol use in the past month
- Right handed (self-report)
- If female, negative urine pregnancy test
- If female, must either agree to practice an effective birth control method; agree to abstinence from intercourse; be surgically sterile or postmenopausal for at least one year
Exclusion Criteria:
- Currently pregnant or breastfeeding
- More than mild cognitive impairment, as determined by a score on the Montreal cognitive assessment (MoCA) <25.
- Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder
- Use in the past 2 weeks of medication or illicit drug with known high pro-convulsant action, as self-reported, or detected using urine toxicology screening; and with accordance to the Physician best Judgment.
- Any history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history).
- Any history of seizures other than febrile childhood seizures (self-reported history)
- Clinically significant hearing impairment
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant. Some of the patients that will be excluded from the imaging part of the study will be included in the clinical part.
- Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
study group
control group
Arm Description
alcoholics - dTMS group
alcoholics - sham group
Outcomes
Primary Outcome Measures
Alcohol usage
The percentage of heavy drinking days (pHDD; 4+ alcohol units per women and 5+ for men, within one day) between the active and sham groups over the follow up period.
Secondary Outcome Measures
Alcohol craving
The scores of the Penn alcohol craving scale (PACS) between the active and sham groups over the follow up period. The PACS is a 5-item questionnaire that measures the individual's alcohol craving in the past week, with each item scored on a scale between 0 and 6 (i.e., minimum value of 0 and maximum value of 30) and higher scores denote higher levels of craving.
Full Information
NCT ID
NCT02691390
First Posted
February 7, 2016
Last Updated
December 27, 2020
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02691390
Brief Title
Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder
Official Title
Exploration of the Potential Role of Anterior Cingulate (ACC) dTMS in Relapse to Alcohol Use
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least 5 days.
Detailed Description
Phase 1: (up to 2 weeks), participants undergo a set of baseline assessments, including questionnaires, rating scales, and resting state functional magnetic resonance imaging (rsfMRI).
Phase 2, patients receive one of two treatments: High-frequency (10Hz, 100 trains of 3 sec with 15 sec inter train interval) dTMS targeting the ACC or sham stimulation for 30 min. Each treatment is preceded by provocation (pouring, holding and smelling the subject's favorite alcoholic beverage) designed to activate the relevant brain circuitry (provocation of symptoms may increase response rate to Deep TMS as was evident in the treatment of PTSD, cigarette smoking and OCD). dTMS sessions are conducted five times per week for 3 weeks, for a total of 15 sessions. A second scan that include rsfMRI and a risk-related decision-making task is conducted at the end of this phase.
Phase 3 includes 12 weeks of patients' follow-up, including clinical visits at weeks 1, 2, 4, 8 and 12 post treatment. During this phase, subjective and objective measures of alcohol use (self-report and analysis of urine samples for levels of ethyl glucuronide (EtG) and ethyl sulfate (EtS), respectively) are collected. Following completion of the main part by the individual, an "open label" treatment using the same parameters of the experiment is offer (regardless of treatment group).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
alcoholics - dTMS group
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
alcoholics - sham group
Intervention Type
Device
Intervention Name(s)
Active dTMS
Intervention Description
dTMS to ACC
Intervention Type
Device
Intervention Name(s)
Sham dTMS
Intervention Description
SHAM - no stimulation
Primary Outcome Measure Information:
Title
Alcohol usage
Description
The percentage of heavy drinking days (pHDD; 4+ alcohol units per women and 5+ for men, within one day) between the active and sham groups over the follow up period.
Time Frame
12 weeks post treatment
Secondary Outcome Measure Information:
Title
Alcohol craving
Description
The scores of the Penn alcohol craving scale (PACS) between the active and sham groups over the follow up period. The PACS is a 5-item questionnaire that measures the individual's alcohol craving in the past week, with each item scored on a scale between 0 and 6 (i.e., minimum value of 0 and maximum value of 30) and higher scores denote higher levels of craving.
Time Frame
12 weeks post treatment
Other Pre-specified Outcome Measures:
Title
Modifications to brain volume
Description
Changes to volumes (cm3) of brain areas that are implicated in alcohol abuse pathophysiology, as measured by MRI from pre- to post-treatment between the active and sham groups.
Time Frame
3 weeks of treatment
Title
Modifications to functional connectivity
Description
Changes to functional connectivity (correlation coefficient) of networks that are implicated in alcohol abuse pathophysiology, as measured by resting state fMRI from pre- to post-treatment between the active and sham groups
Time Frame
3 weeks of treatment
Title
Modifications to blood-oxygen-level-dependent (BOLD) signal
Description
Changes to blood-oxygen-level-dependent (BOLD) signal (arbitrary units) of brain areas that are implicated in alcohol abuse pathophysiology during behavioral tasks, as measured by fMRI following treatment between the active and sham groups.
Time Frame
3 weeks of treatment
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:
Age 18 - 65
Current diagnosis of alcohol dependence
Alcohol use in the past month
Right handed (self-report)
If female, negative urine pregnancy test
If female, must either agree to practice an effective birth control method; agree to abstinence from intercourse; be surgically sterile or postmenopausal for at least one year
Exclusion Criteria:
Currently pregnant or breastfeeding
More than mild cognitive impairment, as determined by a score on the Montreal cognitive assessment (MoCA) <25.
Current diagnosis of schizophrenia, bipolar disorder, or other psychotic disorder
Use in the past 2 weeks of medication or illicit drug with known high pro-convulsant action, as self-reported, or detected using urine toxicology screening; and with accordance to the Physician best Judgment.
Any history of clinically significant neurological disorders, including organic brain disease, epilepsy, stroke, brain lesions, multiple sclerosis, previous neurosurgery or personal history of head trauma that resulted in loss of consciousness for > 5 minutes and retrograde amnesia for > 30 minutes (self-reported history).
Any history of seizures other than febrile childhood seizures (self-reported history)
Clinically significant hearing impairment
Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments) or fear of enclosed spaces). Eligibility will be determined by the "MRI Safety Screening Questionnaire" and verified, if necessary, by a radiology consultant. Some of the patients that will be excluded from the imaging part of the study will be included in the clinical part.
Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the investigators and after any consults if indicated, participation in the study is not in the best interest of the patient.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Deep Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder
We'll reach out to this number within 24 hrs