Ignite Creation Date:
2024-05-06 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05274828
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2022-02-16
Brief Title:
Deep Transcranial Magnetic Stimulation for Stimulants Use Disorder
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Feasibility Study on the Use of an Intensive Deep Transcranial Magnetic Stimulation Protocol in the Treatment of Cocaine and Other Stimulants Use Disorder
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None