Repetitive Transcranial Magnetic stimulation to the inferior parietal lobule in task specific focal hand dystonia;A crossover;sham-control ,blinded outcome assessment study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary outcome will be the Writer’s Cramp Rating Scale (WCRS)
研究概览
简要总结
. Summary - In this crossover study, 50 patients with task specific FHD will be randomized to receive 5 daily sessions of either low frequency (1Hz) inhibitory rTMS [Intervention] or Sham stimulation [Control] over the inferior parietal lobule (IPL).After a washout period of 2 weeks, participants will receive the alternate intervention. The primary outcome will be the Writer’s Cramp Rating Scale (WCRS) immediately after the intervention session. Secondary outcomes will include kinematic analysis (accelerometry, goniometry, handwriting kinematics), patient global impression of change scale, resting and task based functional MRI assessments. We expect to generate novel data that will deepen the understanding of the pathophysiological mechanisms in FHD and contribute to a non-invasive, efficacious and safe treatment strategy for the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Day(s) 至 60.00 Day(s)（—）
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be included in the study: a) Diagnosis of isolated, task specific focal hand dystonia as per MDS consensus update on phenomenology and classification of dystonia1 by 2 independent movement disorder specialists.b) Age 18-60 years2 .c) Not received BONT injections in the past 4 months.d) No localscalp infections/ wounds e) Able to give informed consent.
排除标准
- •Exclusion criteria Participants meeting any of the following the criteria will be excluded from the study a) History of brain tumour, stroke, traumatic brain injury, epilepsy or seizure in lifetime.
- •b) History of major depression, psychosis c) Implanted pacemaker, intracardiac lines, pumps or stimulators, or metallic foreign bodies inside the eye or skull.
- •(Dental fillings and braces are allowed) d) Pregnancy (negative UPT in 2 weeks) Age and gender matched Healthy volunteers, with no known neurological complaints will be included for validation of fMRI, electrophysiology and kinematic protocols.
结局指标
主要结局
The primary outcome will be the Writer’s Cramp Rating Scale (WCRS)
时间窗: The primary outcome will be the Writer’s Cramp Rating Scale (WCRS) | immediately after the intervention session.
immediately after the intervention session.
时间窗: The primary outcome will be the Writer’s Cramp Rating Scale (WCRS) | immediately after the intervention session.
次要结局
- Secondary outcomes will include kinematic analysis((accelerometry, goniometry, handwriting kinematics), patient global impression of change scale, resting)
研究者
DrRoopa Rajan
AIIMS, New Delhi