Informations générales (source: ClinicalTrials.gov)

NCT04997330 Statut inconnu
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
Interventional
  • Alcoolisme
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
septembre 2021
juillet 2023
03 décembre 2025
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.
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Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLINIQUE MONTEVIDEO LEVY Fanny En recrutement IDF 13/12/2025 07:21:06  Contacter
AP-HP Assistance publique - Hôpitaux de Paris En recrutement IDF 13/12/2025 07:21:06  Contacter
AP-HP - Hôpital La Pitié-Salpêtrière
AP-HP - Hôpital Louis Mourier
AP-HP - Hôpital Saint Antoine
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Universitaire Pitié-Salpêtrière - 75013 - Paris - France Anne Radenne Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Age between 18-75 years

- Alcohol use disorder according to DSM 5, moderate to mild according to ADS

- Residential stay for alcohol detoxofication



- 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)

- 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

Secondary inclusion criteria (before randomization):

- 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.