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临床试验/NCT06015672
NCT06015672进行中(未招募)不适用

Duke Accelerated Transcranial Magnetic Stimulation for Focal Hand Dystonia

Duke University1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年12月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
21
试验地点
1
主要终点
Change in behavioral writing measure

研究概览

简要总结

This study aims to investigate the impact of accelerated transcranial magnetic stimulation (TMS) on brain function and behavior in patients with focal hand dystonia. Previous research demonstrated that individualized TMS improved dystonic behavior after one session. Building on this, the current study administers four TMS sessions in a day, with assessments conducted in four weeks, twelve weeks, and 20 weeks after each session. The research involves 8 in-person and 6 virtual visits focused on functional MRI brain scans and writing behavior analysis. The potential risk of seizures from TMS is mitigated through careful screening, adhering to safety guidelines. The study's main benefit is enhancing dystonic behavior and deepening the understanding of brain changes caused by TMS in focal hand dystonia, paving the way for further advancements in clinical therapy for this condition.

详细描述

The primary aim of this research is to investigate the impact of transcranial magnetic stimulation (TMS) on both brain function and behavioral outcomes among individuals suffering from focal hand dystonia. A preliminary examination of a previous TMS study carried out by our team revealed that the application of TMS, using personalized, fMRI-guided brain targeting and interleaved TMS delivery during motor tasks, has the potential to modify brain activity and ameliorate dystonic behavior after a single session of TMS in patients with focal hand dystonia. This present study seeks to build upon these promising findings by administering four TMS sessions in a single day, interspersed with four rest intervals, a protocol referred to as "accelerated TMS." The investigation will consist of a total of eight in-person appointments. Participants with focal hand dystonia will receive accelerated TMS during two in-person visits. Following each TMS session, participants will evaluate changes in brain function and behavior. During the assessment visits, individuals will undergo functional MRI brain scans and engage in writing tasks on an electronic tablet. The principal risk associated with TMS is the possibility of inducing a seizure. However, this study will strictly adhere to safety guidelines, utilizing TMS levels that have not previously been linked to seizures in properly screened individuals. Notably, the dosages of TMS proposed for use in this study have not caused seizures in healthy volunteers. To further mitigate the risk of seizures, potential subjects will undergo medical screening for any known factors that could predispose them to seizures. The primary advantage of this study lies in its potential to enhance dystonic behavior in patients with focal hand dystonia, while also deepening our comprehension of the foundational changes in brain function before and after TMS intervention for focal hand dystonia. The discoveries stemming from this investigation will pave the way for future research endeavors aimed at advancing brain stimulation as a viable clinical therapy for focal hand dystonia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The TMS intensity 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

入选标准

  • 18yrs and older
  • Diagnosed with isolated focal hand by Neurologist
  • Right-hand dominant
  • Must be able to sign an informed consent
  • Must be literate

排除标准

  • Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
  • History of seizure disorder
  • Concomitant medications are known to decrease seizure threshold
  • Illicit drug use
  • No TMS therapy for another indication within one month of this research study
  • Botulinum toxin injections within 3months of the research study
  • Medications used for symptom treatment of dystonia including anticholinergic, benzodiazepines, and muscle relaxants among others within one month of the study
  • No physical or occupational therapy of the hand within one month of the study
  • Any contraindications to MRI or TMS

研究组 & 干预措施

TMS to primary somatosensory cortex

Active Comparator

Participants received TMS sessions at primary somatosensory cortex

干预措施: Transcranial Magnetic Stimulation (TMS) (Device)

TMS at low amplitude to primary somatosensory cortex

Sham Comparator

Participants receive TMS at a cortical target at smaller amplitude

干预措施: Transcranial Magnetic Stimulation (TMS) (Device)

结局指标

主要结局

Change in behavioral writing measure

时间窗: Baseline, 4 weeks, 12 weeks, 20 weeks, 24, weeks, 32 weeks and 40 weeks

Using change in peak accelerations to assess writing behavior

Change in brain connectivity in the motor network

时间窗: Baseline, 12 weeks, 20 weeks and 32 weeks

Using functional magnetic resonance imaging of the brain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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