Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3J4, Canada
NCT Number: NCT05274828
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).
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Montreal, Quebec, H2X 3J4, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Study group will receive dTMS treatment three times a day for ten days.
Other names: H7-Coil Deep TMS Treatment
Time frame: after 10 days of treatment sessions
Number of completer treatment sessions
Time frame: after 10 days of treatment sessions
Number of patients who did not completed the total (40) sessions
Time frame: up to three months after end of the treatment
Adverse events reported
Time frame: up to three months after end of the treatment
Presence of Stimulants in the Drug Screen Panel
Time frame: T0 (week 0), T1 (end of treatment, week 2), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on Stimulants Craving Questionnaire
Time frame: 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 (Minimum score 0 and Maximum score 126, higher score means worse outcome in terms of substance withdrawal symptoms)
Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on Patient Health Questionnaire (PHQ-9)
Time frame: T0 (week 0), T2 (week 4), T3 (week 6), T4 (week 14)
Percentage change on General Anxiety Disorder (GAD-7)
Centre hospitalier de l'Université de Montréal (CHUM)
Other
Feasibility Study on the Use of an Intensive Deep Transcranial Magnetic Stimulation Protocol in the Treatment of Cocaine and Other Stimulants Use Disorder
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