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临床试验/NCT07291687
NCT07291687招募中不适用

Transcranial Direct Current Stimulation as a Treatment for Motor Function in Participants Living With Progressive Supranuclear Palsy, Corticalbasal Syndrome Degeneration, or Parkinson's Disease

Baycrest2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
2
主要终点
Gait speed

研究概览

简要总结

Previous preliminary results are sufficiently impressive to suggest that tDCS stimulation does have the potential to improve motor function when that ability is trained during stimulation. In the proposed study, the investigation will assess whether walking sessions combined with tDCS lead to improvements in motor function: gait, articulation, eye gaze, and motor dexterity. In addition, the investigators wish to examine if such results can be replicated in people with other conditions, such as cortical basal syndrome, and Parkinson's disease.

详细描述

Previous preliminary results are sufficiently impressive to suggest that tDCS stimulation does have the potential to improve motor function when that ability is trained during stimulation. In the proposed study, the investigators will assess whether walking sessions combined with tDCS lead to improvements in motor function: gait, articulation, eye gaze, and motor dexterity. In addition, the investigators wish to examine if such results can be replicated in people with other conditions, such as cortical basal syndrome, and Parkinson's disease. The rationale for including people living with these conditions is the overlap in motor and cortical network dysfunction observed across these disorders. All three conditions involve impairment of motor initiation, gait, coordination, and executive motor control due to degeneration in frontal-subcortical pathways. This extension will also allow for comparison of stimulation responsiveness across related diagnostic groups and provide insight into disease-specific factors influencing motor recovery potential.

Previous tDCS studies have found significant results with sample sizes between 10-20 participants for a two-round study comparing training sessions with real tDCS versus sessions done without tDCS. However, the investigators plan to recruit 30 participants living with each condition as this will allow us to examine results per group, but also how the individual groups compare.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants must be able to walk unassisted, or with the assistance of a walker or cane, and be individuals who walk daily.
  • 2. Participants should have a sufficient level of English to be able to express themselves verbally, be able to read and follow instructions.

排除标准

  • 3. Individuals with metal implants within the brain such as shunts will be excluded.

结局指标

主要结局

Gait speed

时间窗: Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.

Within each round, scores from the final week and final session of real tDCS stimulation will be compared to performance during the first week and final sham tDCS session to check for significant improvement. Our primary outcome measures will be those found for gait; for example, a faster walking time subsequent to tDCS stimulation compared to the placebo baseline. Participants will also return two weeks later for a post-stimulation evaluation to check if improvement was maintained. To check if the arrangement of electrodes impacts the effect, times from the final tDCS session of each round will be compared.

Gait speed

时间窗: Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.

Within each round, scores from the final week and final session of real tDCS stimulation will be compared to performance during the first week and final sham tDCS session to check for significant improvement. Our primary outcome measures will be those found for gait; for example, a faster walking time subsequent to tDCS stimulation compared to the placebo baseline. Participants will also return two weeks later for a post-stimulation evaluation to check if improvement was maintained. To check if the arrangement of electrodes impacts the effect, times from the final tDCS session of each round will be compared.

次要结局

  • Articulation Quality (Clinician-Rated Speech Production on Word and Sentence Repetition)(Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.)
  • Eye-Gaze Control (Clinician-Rated Ability to Track a Moving Target)(Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.)
  • Articulation Quality (Clinician-Rated Speech Production on Word and Sentence Repetition)(Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.)
  • Eye-Gaze Control (Clinician-Rated Ability to Track a Moving Target)(Measures collected at three points each round: baseline in week 1, post-treatment at the final stimulation session, and follow-up two weeks after the final session.)

研究者

发起方
Baycrest
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tyler Roncero

Principle Investigator

Baycrest

研究点 (2)

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