TBS study for alcohol use disorder

JRCT ID: jRCTs032230651

Registered date:22/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alcohol Use Disorder
• Date of first enrollment: 22/02/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): MRI neuro-navigation system will be used to identify the optimal stimulation site in the prefrontal cortex for each subject, and theta burst stimulation(TBS) protocol will be performed once a day for a total of 15 times in about 3 weeks.

Outcome(s)

• Primary Outcome: Number of heavy episodic drinking days in 4 weeks based on TLFB(Timeline Followback)

Secondary Outcome

<Psychiatric symptoms>
-Severity of mood symptoms assessed with HRSD-21
-Degree of anxiety assessed with BSI-anxiety
-Degree of suicidal ideation assessed with BSS
-Severity of functional impairment assessed with WHODAS 2.0
-Degree of anxiety assessed with STAI

<Cognitive functions>
-RBANS
-LNST
-SNST
-TMT
-EXIT25

<Alcohol consumption behaviors>
-Number of drinking days based on TLFB
-Total alcohol consumption in 4 weeks based on TLFB
-Mean alcohol consumption in 4 weeks based on TLFB
-Mean alcohol consumption per drinking days in 4 weeks based on TLFB
-Severity of compulsive drinking assessed with OCDS
-Severity of alcohol relapse risk assessed with ARRS
-Quality of Life assessed with AQoLS
-Severity of alcohol dependence assessed with AUDIT

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

1.Outpatients who meet the criteria for alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
2.Outpatients who provided informed consent
3.Men and women between the ages of 20 and 64 at the time of obtaining written informed consent
4.Outpatients who are able to visit Keio University Hospital according to our research schedule
5.Outpatients whose mental states are stable enough to take examinations that may take approximately four hours

Exclude criteria

1. Patients who have organic brain diseases (e.g., intracranial organic lesions of moderate or higher grade, or neurodegenerative diseases)
2. Patients with a history of seizures or epilepsy
3. Patients with serious or unstable physical illnesses
4. Receiving electroconvulsive therapy within 6 months prior to enrollment
5. Being pregnant, breastfeeding, or hoping to become pregnant
6. Having a metallic substance in the body or having a peacemaker
7. Patients with claustrophobia
8. Having tattoos (including tattoos and art make-up) that are larger than one point in the head or neck
9. The size of the head, neck and body are not suitable for MRI scanners
10. Having obvious hearing loss
11. Those deemed unsuitable as research subjects by the principal investigator

Related Information

• Primary Sponsor: Nakajima Shinichiro
• Source(s) of Monetary Support: The Watanabe Foundation,JSR-Keio University Medical and Chemical Innovation Center,Osake-no-Kagaku Foundation,Asahi Quality &amp; Innovations , Ltd.