Neuromodulation for Rehabilitation of Post-Stroke Fatigue: An rTMS Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in Fatigue Severity Scale (FSS) score
研究概览
简要总结
This experimental trial is investigating the use of magnetic stimulation of the brain as a possible treatment for post-stroke fatigue in people who have had a stroke more than six months prior to enrolling. Fatigue is a common condition after a stroke and can negatively impact an individual's ability to perform desired social and physical activities. Magnetic stimulation of the brain has been shown to improve signs and symptoms of related psychological (e.g., depression) conditions. Participants in this trial will receive a type of magnetic stimulation called repetitive transcranial magnetic stimulation, or rTMS. The investigators will measure feelings of fatigue and other clinical characteristics related to mood and cognition before and after participants receive rTMS.
详细描述
The PI for this trial transferred to the Atlanta VA Medical Center in Feb 2026. As a result, the trial was suspended at the original site and moved to the Atlanta area. Additional changes accompanying the site transfer include removing one arm of the study (an active comparator), leaving two arms: one with the active treatment and the other with a sham treatment. Eligibility criteria were also updated to be more ecologically relevant. Ethical approvals for the new site, Atlanta, were provided by the Emory University IRB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to their groups
入排标准
- 年龄范围
- 34 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 6 months post-stroke
- •Clinically present fatigue
排除标准
- •Contraindications to magnetic resonance imaging (MRI)/transcranial magnetic stimulation (TMS)/repetitive transcranial magnetic stimulation (rTMS), e.g., implanted metal within the head, history of seizures
- •Inability to follow simple three-step instructions
- •Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, moderate/severe traumatic brain injury (TBI)
- •Pregnancy
- •Strokes within stimulation sites
- •Pregnancy
- •Severe hypertension (resting systolic blood pressure (SBP) > 200, DBP > 120)
研究组 & 干预措施
Real M1 High Frequency rTMS
Participants will be randomly assigned to receive high-frequency repetitive transcranial magnetic stimulation (rTMS) to the top of their head for approximately 40 minutes.
干预措施: High frequency repetitive transcranial magnetic stimulation (Device)
Sham rTMS
Participants will be randomly assigned to receive sham/placebo repetitive transcranial magnetic stimulation (rTMS) to the their head for approximately 40 minutes. This is a control condition.
干预措施: Sham repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Change in Fatigue Severity Scale (FSS) score
时间窗: Change from baseline FSS score to 7 days after last treatment
The Fatigue Severity Scale (FSS) is a patient reported outcome measure assessing perceived influence of fatigue over the past week. The scale consists of nine questions measured on a 7-point Likert scale (1-7). The FSS' range of scores is from 9 (min) to 63 (max) with lower numbers representing lower/less impact of fatigue.
次要结局
- Change in Modified Fatigue Impact Scale (MFIS) score(Change from baseline MFIS score to 3 months after last treatment)
- Change in Fatigue Severity Scale (FSS) score(Change from baseline FSS score to 3 months after last treatment)
- Change in Modified Fatigue Impact Scale (MFIS) score(Change from baseline MFIS score to 7 Days after last treatment)