Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation on Alcohol Use Disorder: A One-Year, Randomized, Double-Blind MRI Tracking Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Alcohol Use Disorders Identification Test (AUDIT) total score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Active rTMS
Ten sessions of active repetitive transcranial magnetic stimulation over the right dorsolateral prefrontal cortex (F4), 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. All participants received active stimulation in addition to usual abstinence-oriented care, which included pharmacological and psychosocial treatment that was not protocolized.
干预措施: Repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Change in Alcohol Use Disorders Identification Test (AUDIT) total score
时间窗: 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.
次要结局
- Change in Patient Health Questionnaire-9 (PHQ-9) score(Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months)
- Change in craving visual analogue scale score(Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months)
- Change in WHOQOL-BREF total score(Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months)
- Change in resting-state functional connectivity(Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months)
- Change in white matter diffusion metrics(Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months)
- Change in brain metabolite concentrations(Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months)
- Adverse events(Throughout the stimulation course and follow-up, up to 3 months)
研究者
Ting-Gang Chang
Chief, Division of Addiction Medicine, Department of Psychiatry, Taichung Veterans General Hospital, Taiwan
Taichung Veterans General Hospital