Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05859347
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-04-11
Brief Title:
Repetitive Transcranial Magnetic Stimulation for Cannabis Use Disorder
Sponsor:
Centre for Addiction and Mental Health
Organization:
Centre for Addiction and Mental Health
Study Overview
Official Title:
Development of a Novel Scalable Neurobiologically-Guided Transcranial Magnetic Stimulation Protocol for the Treatment of Cannabis Use Disorder
Status:
RECRUITING
Status Verified Date:
2023-08
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:
There has been a considerable rise in cannabis consumption in recent years with estimates of 200 million individual users globally Importantly 3 of these individuals have cannabis use disorder CUD with this prevalence increasing to 33 amongst regular users making it one of the most common substances use disorders SUDs worldwide CUD is associated with substantial health societal and economic costs and worsening of other psychiatric disorders Despite this clinical burden effective treatment options are limited No pharmacological treatments have emerged as clearly efficacious and psychotherapeutic interventions have shown tempered results
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue As it can modulate neural circuits implicated in neuropsychiatric disorders it is a promising brain-based approach in the treatment of addictions Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs although research into cannabis has been largely unexplored Recently a novel circular rTMS coil the MagVenture MMC-140 has been developed with the capacity to modulate both the bilateral prefrontal cortex PFC and insula both of which are implicated in the neurocircuitry of craving and executive function As such it shows potential for CUD treatment
This proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFCinsula using MMC-140 as a treatment for CUD Feasibility of both high frequency HF excitatory and low frequency LF inhibitory stimulation parameters will be evaluated In addition prepost rTMS changes in cannabis use outcomes eg consumption craving and withdrawal executive function and PFCinsula functional connectivity will be explored By comprehensively investigating clinical cognitive and neuroimaging effects of rTMS this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel cost-effective and accessible rTMS device
Repetitive transcranial magnetic stimulation rTMS is a non-invasive brain-based approach in which alternating magnetic fields are applied to the scalp to induce electrical currents in cortical tissue As it can modulate neural circuits implicated in neuropsychiatric disorders it is a promising brain-based approach in the treatment of addictions Evidence has indicated its efficacy in reducing drug craving and consumption across numerous SUDs although research into cannabis has been largely unexplored Recently a novel circular rTMS coil the MagVenture MMC-140 has been developed with the capacity to modulate both the bilateral prefrontal cortex PFC and insula both of which are implicated in the neurocircuitry of craving and executive function As such it shows potential for CUD treatment
This proof-of-concept clinical trial will evaluate the feasibility and tolerability of a 4-week course of rTMS to the PFCinsula using MMC-140 as a treatment for CUD Feasibility of both high frequency HF excitatory and low frequency LF inhibitory stimulation parameters will be evaluated In addition prepost rTMS changes in cannabis use outcomes eg consumption craving and withdrawal executive function and PFCinsula functional connectivity will be explored By comprehensively investigating clinical cognitive and neuroimaging effects of rTMS this study could pave the way for the first brain-based intervention in CUD that could be widely adopted into clinical settings using a novel cost-effective and accessible rTMS device
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None