Development of Mechanistically Informed Therapy for Task-Specific Dystonia Using Noninvasive Neuromodulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Feasibility of accurately delivering TMS during the task of writing as measured by number of participants who completed the TMS sessions
研究概览
简要总结
This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.
详细描述
The primary objective of this study is to develop rTMS for FHD. The focus is to assess whether stimulating the PMC or PSC will show greater improvement in writing behavior. This research builds upon prior studies that have demonstrated improvement in behavior after rTMS to PMC and PSC. The study includes five sequential visits:
- Visit 1 behavior writing measures and dystonia rating scales.
- Visit 2 includes task-based functional MRI brain scans to develop cortical target for rTMS sessions.
- Visits 3, 4, and 5: FHD participants receive 10 Hz rTMS to PMC, PSC and sham rTMS to PMC in a cross over design with at minimum one week of washout between sessions. Participants complete behavior writing measures and rating scales on same day before and after each TMS session and an fMRI after each TMS session. Up to 5 Healthy Volunteers were recruited to help develop the TMS visits.
The information in this record reflects Visits 3-5
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The TMS intensity and cortical location delivered at each TMS visit will be masked
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Control Participants:
- •18yrs and older
- •Left or Right hand dominance
- •Age-matched to Focal Hand dystonia patients
- •Must be able to sign informed consent
- •Must be literate
- •Focal Hand dystonia Patients:
- •18yrs and older
- •Left or Right hand dominance
- •Diagnosed with Writer's Cramp dystonia in left or right hand
- •Must be able to sign informed consent
- •Must be literate
排除标准
- •Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):
- •Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
- •Botulinum toxin injections within 3 months of research study
- •Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
- •No physical or occupational therapy of the upper extremities
- •Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)
- •Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion
研究组 & 干预措施
10 Hz rTMS to premotor cortex
10 Hz rTMS to premotor cortex
干预措施: Repetitive transcranial magnetic stimulation (Device)
10 Hz rTMS to primary somatosensory cortex
10 Hz rTMS to primary somatosensory cortex
干预措施: Repetitive transcranial magnetic stimulation (Device)
0.7 Hz rTMS to premotor cortex
0.7 Hz rTMS to premotor cortex
干预措施: Repetitive transcranial magnetic stimulation (Device)
结局指标
主要结局
Feasibility of accurately delivering TMS during the task of writing as measured by number of participants who completed the TMS sessions
时间窗: Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3)
Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions
时间窗: Pre-TMS and post-TMS session (each session is approximately 45 minutes)
次要结局
- Feasibility, as measured by change in behavioral writing measure(Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3))
- Change in brain connectivity in the motor network(Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3))
- Safety, as measured by TMS acute side effects(Visit 3 (week 1), Visit 4 (week 2), Visit 5 (week 3))
- Safety, as Measured by TMS Acute Side Effects(During TMS session (each session is approximately 45 minutes))
- Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).(Pre-TMS and post-TMS session (each session is approximately 45 minutes))
- Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII(Post-TMS session (each session is approximately 45 minutes))