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TBS study for alcohol use disorder

Development of next-generation neuromodulatory therapeutics by theta burst stimulation for alcohol use disorder and elucidation of its therapeutic mechanism - Next-generation neuromodulatory therapeutics by TBS for alcohol use disorder

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230651
Enrollment
30
Registered
2024-02-22
Start date
2024-02-22
Completion date
Unknown
Last updated
2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder Alcohol Use Disorder

Interventions

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

Sponsors

Nakajima Shinichiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Number of heavy episodic drinking days in 4 weeks based on TLFB(Timeline Followback)

Secondary

MeasureTime frame
-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 -Physical Anhedonia Scale -RBANS -LNST -SNST -TMT -EXIT25 -Goldsmiths Musical Sophistication Index (Gold-MSI) -Barcelona music reward questionnaire -Groove task -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

Contacts

Public ContactShinichiro Nakajima

Keio University Hospital

piojo629.a6@keio.jp+81-3-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026