Alcoholism, Alcohol Use Disorder (AUD)
Conditions
Keywords
Repetitive transcranial magnetic stimulation, Dorsolateral prefrontal cortex, Alcohol Use Disorders Identification Test, Resting-state functional MRI, Diffusion tensor imaging, Magnetic resonance spectroscopy, Pilot study
Brief summary
This study looked at whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment, could help adults with alcohol use disorder when added to their usual treatment. Nine adults receiving abstinence-oriented care received 10 sessions of stimulation over the right front part of the brain. Drinking severity, mood, craving and quality of life were assessed before treatment, immediately after the 10 sessions, and again at one and three months. Brain scans were also obtained at these visits to examine whether stimulation was associated with changes in brain connections. The study had no comparison group, so the results cannot show whether any change was caused by the stimulation.
Detailed description
This was a single-arm, open-label pilot study conducted at a single medical centre in Taiwan. Adults aged 20 to 65 years with DSM-5 alcohol use disorder were enrolled during inpatient or outpatient abstinence-oriented care, after the treating physician confirmed that acute withdrawal had stabilized. Stimulation was delivered over the right dorsolateral prefrontal cortex at the F4 position using a Magstim Rapid2 system with a figure-of-eight D70 mm air film coil: 10 sessions at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. Concomitant pharmacological and psychosocial treatment continued as usual care and was not protocolized. Assessments were conducted at baseline, after the tenth session, and at one and three months, and comprised clinical measures (Alcohol Use Disorders Identification Test, Patient Health Questionnaire-9, craving visual analogue scales, WHOQOL-BREF) and multimodal magnetic resonance imaging (resting-state functional MRI, diffusion tensor imaging and magnetic resonance spectroscopy). The study was originally approved as a one-year, randomized, double-blind, sham-controlled trial with a larger planned sample. Funding constraints and difficulty recruiting this population prevented completion of that design, and the study was conducted as a single-arm, open-label pilot with follow-up to three months. The trial was registered retrospectively.
Interventions
DEVICERepetitive transcranial magnetic stimulation
High-frequency repetitive transcranial magnetic stimulation
Sponsors
Ting-Gang Chang
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Originally designed as a two-arm, randomized, double-blind, sham-controlled trial. Funding constraints and recruitment difficulty prevented completion of that design; all enrolled participants received active stimulation and the study was conducted as a single-arm, open-label pilot.
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 20 to 65 years * Diagnosis of alcohol use disorder according to DSM-5 criteria * Able to provide written informed consent and complete study procedures
Exclusion criteria
* Moderate to severe alcohol withdrawal * Psychiatric symptoms interfering with alcohol use disorder treatment * Acute physical illness requiring hospitalization * Standard contraindications to repetitive transcranial magnetic stimulation * Pregnancy or planned pregnancy within one year * Formal disability certification related to a psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Alcohol Use Disorders Identification Test (AUDIT) total score | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | AUDIT total score, range 0 to 40, with higher scores indicating more severe alcohol-related problems. Change from baseline was assessed at each follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) score | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | PHQ-9 total score, range 0 to 27, higher scores indicating more severe depressive symptoms. |
| Change in craving visual analogue scale score | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | Visual analogue scale, range 0 to 10, higher scores indicating stronger craving. |
| Change in WHOQOL-BREF total score | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | WHOQOL-BREF (Taiwan version) total score, higher scores indicating better quality of life. |
| Change in resting-state functional connectivity | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | Whole-brain and network-level functional connectivity derived from resting-state functional MRI using the Schaefer 100-parcel, seven-network atlas. |
| Change in white matter diffusion metrics | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | Fractional anisotropy and mean diffusivity derived from diffusion tensor imaging. |
| Change in brain metabolite concentrations | Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months | Metabolite concentrations measured by single-voxel magnetic resonance spectroscopy. |
| Adverse events | Throughout the stimulation course and follow-up, up to 3 months | Adverse events elicited by open-ended enquiry at each stimulation session and imaging visit. |
Countries
Taiwan
Outcome results
None listed