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The purpose of the study is to explore the Feasibility, Tolerability and Safety of the H7-Coil deep Transcranial Magnetic Stimulation for Subjects with Stimulants Use Disorder (SUD).
Stimulants Use Disorder (SUD) is a major public health issue, with potentially severe psychosocial and medical consequences. Even though psychosocial therapies exist, an important proportion of patients do not respond to these approaches, and no approved biological approaches are currently available. deep TMS (dTMS) has been shown effective for Major Depressive Disorder, Obsessive Compulsive Disorder and Nicotine Use Disorder and could also prove available for SUD. Several pilot studies have shown preliminary effectiveness in SUD, but are limited by the length of their protocol, which could result in limited real-world effectiveness secondary to high dropout rates. Given that aTMS protocols have been applied successfully in MDD, we propose to implement this approach for SUD, in order to reduce treatment length and therefore increase retention rates. We will also gather preliminary data on various biomarkers that could help predict response and better understand biological mechanisms behind SUD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H7-Coil Deep TMS Treatment | Experimental | H7-Coil Deep TMS Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H7-Coil Deep TMS for CUD | Device | The Study group will receive dTMS treatment three times a day for ten days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility-related endpoints - adherence to dTMS | Number of completer treatment sessions | after 10 days of treatment sessions |
| Feasibility-related endpoints - retention rates | Number of patients who did not completed the total (40) sessions | after 10 days of treatment sessions |
| Adverse Events reported | Adverse events reported | up to three months after end of the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Positive Urine Drug Screen to Stimulants | Presence of Stimulants in the Drug Screen Panel | up to three months after end of the treatment |
| Percentage change on Stimulants Craving Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe Miron, MD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Montreal | Quebec | H2X 3J4 | Canada |
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Single Group Assignment
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Percentage change on Stimulants Craving Questionnaire
| T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14) |
| Percentage change on Stimulants Selective Severity Assessment | Percentage change on Stimulants Selective Severity Assessment (Minimum score 0 and Maximum score 126, higher score means worse outcome in terms of substance withdrawal symptoms) | T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14) |
| Percentage change on Patient Health Questionnaire (PHQ-9) | Percentage change on Patient Health Questionnaire (PHQ-9) | T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14) |
| Percentage change on General Anxiety Disorder (GAD-7) | Percentage change on General Anxiety Disorder (GAD-7) | T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14) |