Evaluation of Bilateral HF-rTMS on Abstinence in Alcohol Use Disorder Patients With Executive Dysfunction
NCT ID: NCT04997330
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
95 participants
INTERVENTIONAL
2021-09-30
2023-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active rTMS
Bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
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.
Sham rTMS
Sham bilateral high frequency (20Hz) Repetitive Transcranial Magnetic Stimulation (rTMS) over DLPFC
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Alcohol use disorder according to DSM 5, moderate to mild according to ADS
* Residential stay for alcohol detoxofication
\- Abnormal executive function defined as at least 3 impaired measurements among 19 measurements of 7 tests (Stroop test, Wisconsin test; Trail making test, verbal fluency, 6 elements, Brixton test, Dual task Baddeley test) from the Greffex battery. Each measure will be considered as impaired if it is below 1.65 SD. The procedure and the measurement are standardized. The neuropsychological evaluation will be performed at least seven days after alcohol detoxification and after at least 12 hours after benzodiazepine cessation.
Exclusion Criteria
* 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)
* Deprive of freedom or security measure
* No adequate mastering of the French language or no ability to consent
* Major socio-economic problem: homelessness
* No written informed consent
* Participation in another interventional study
18 Years
75 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Fanny LEVY, Docteur
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Universitaire Pitié-Salpêtrière
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020-A00548-31
Identifier Type: OTHER
Identifier Source: secondary_id
APHP180582
Identifier Type: -
Identifier Source: org_study_id
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