Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction
STIM-ALC
2 other identifiers
interventional
95
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2021
CompletedFirst Posted
Study publicly available on registry
August 9, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedAugust 30, 2021
March 1, 2021
1.7 years
July 31, 2021
August 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with continuous complete alcohol abstinence
Percentage of patients with continuous complete abstinence up to one month after the end of the rTMS treatment. The abstinence will be assessed using the Alcohol-Time Line Follow Back tool (TLFB). The Alcohol TLFB is a descriptive questionnaire, using a calendar, participants will retrospectively record at M1 the number of days they drank over the 30 days following the end of the rTMS treatment. Continuous complete abstinence will be defined as no day with alcohol consumption over the 30 days.
1 month after the end of rTMS sessions
Secondary Outcomes (28)
Percentage of participants with alcohol continuous complete abstinence
3 months after the end of rTMS sessions
Number of cumulative abstinence days
1 month after the end of rTMS sessions
Number of cumulative abstinence days
3 months after the end of rTMS sessions
Time until the first heavy drinking days (HDD)
3 months after the end of rTMS sessions
Number of heavy drinking days (HDD)
1 month after the end of rTMS sessions
- +23 more secondary outcomes
Study Arms (2)
Active rTMS
EXPERIMENTALBilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
Sham rTMS
PLACEBO COMPARATORSham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age between 18-75 years
- Alcohol use disorder according to DSM 5, moderate to mild according to ADS
- Residential stay for alcohol detoxofication
You may not qualify if:
- Cognitive deficits defined by MoCA \<25 (Montreal Cognitive Assessment) performed at least 7days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation
- History of cerebral stroke
- DSM-5 substance use disorders other than nicotine and alcohol
- Contraindication for rTMS :
- Pregnancy
- History of epilepsy or seizure
- Cochlear implants
- Cardiac pacemaker or intracardiac lines, or metal in the body
- Clinical history of complicated withdrawal symptoms
- History of severe head trauma followed by loss of consciousness
- Actual major depressive episode, schizophrenia according to the MINI (Mini International Neuropsychiatric Interview)
- Breastfeeding women
- Actual or history of organic failure including cirrhosis
- Absence of health insurance; or patient with AME
- Legal protection (curatorship or tutorship)
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fanny LEVY, Docteur
Assistance Publique - Hôpitaux de Paris
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2021
First Posted
August 9, 2021
Study Start
September 1, 2021
Primary Completion
May 1, 2023
Study Completion
July 1, 2023
Last Updated
August 30, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
- Access Criteria
- Researchers who provide a methodologically sound proposal
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.