NCT04997330

Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction

Evaluation of Bilateral HF-rTMS Over DLPFC in add-on to Usual Treatment on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction After Withdrawal

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

High frequency repetitive transcranial magnetic stimulation (HF-rTMS) over dorsolateral prefrontal cortex (DLPFC) could correct defective executive functions over the hyperactive reward circuit through the meso-fronto-limbic connections. The restored cortical inhibitory control over compulsive alcohol use, could improve abstinence after withdrawal. The goal of this study is to evaluate the efficacy of HF-rTMS over DLPFC in AUD patients with executive dysfunction after withdrawal.

Detailed description

PARTICIPANTS: Participants with AUD (moderate to mild according to Alcohol Dependance Scale) with executive dysfunctions will be randomized. DESIGN: This study is a multicenter pilot double blind randomized controlled trial. After at least seven days of alcohol residential detoxification, executive dysfunctions's participants will be tested. 64 of them with executive dysfunctions will be randomized either in the active rTMS group or in the sham rTMS group. TMS will be performed during hospitalisation over 10 days. rTMS are proposed as an add on to the usual treatment. INTERVENTION: 20 rTMS (twice a day) will be performed 10 consecutive working days. The target of the rTMS will be the DLPFC (left side in the morning, right side in the afternoon). During each rTMS sessions (active and sham), alcohol related pictures from the Geneva Appetitive alcohol Pictures will be presented.In the active arm, rTMS will be performed with high frequency (20hz, 1500 pulses per session, 110% of motor threshold).In the control group, sham rTMS will be performed. Participants will be follow up to three months after the end of rTMS treatment.

Conditions

• Alcohol Withdrawal

Interventions

Type	Name	Description
DEVICE	Active rTMS	Bilateral high frequency (20Hz) rTMS will be delivered (over dorsolateral prefrontal cortex), at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive days on working day, 1500 pulses/session, 110% of motor threshold determined, 30 trains, 50 pulses per train and 15s inter train. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
DEVICE	Sham rTMS	Sham rTMS will be delivered (over dorsolateral prefrontal cortex) , at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive working days. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2021-08-09
• Last updated: 2021-08-30

Locations

1 site across 1 country: France