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dTMS intervention to reduce recurrent alcohol abuse among alcohol users who are abstinent for at least 5 days.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Experimental | alcoholics - dTMS group |
|
| control group | Sham Comparator | alcoholics - sham group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active dTMS | Device | dTMS to ACC |
| |
| Sham dTMS |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Modifications to brain volume | 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. | 3 weeks of treatment |
| Modifications to functional connectivity |
Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Device |
SHAM - no stimulation |
|
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 |
| 3 weeks of treatment |
| Modifications to blood-oxygen-level-dependent (BOLD) signal | 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. | 3 weeks of treatment |