Individualized Neuro-Modulation Paired With Cerebellar Therapy (IMPACT)
研究概览
详细说明
Cerebellar damage causes debilitating ataxia affecting balance, coordination, speech, and cognition. Rehabilitation therapy is the main treatment for ataxia because pharmacological therapeutics are extremely limited. Non-invasive brain stimulation has shown promise in improving motor function and has an excellent safety profile. However, optimal stimulation sites and efficacy when combined with rehabilitation remain unclear.
We hypothesize that three weeks of intensive rehabilitation therapy paired with personalized transcranial direct current stimulation (tDCS) will produce greater functional improvements in people with cerebellar damage compared to therapy with sham stimulation.
This double-blind, randomized, sham-controlled trial will enroll participants with cerebellar damage. We will determine stimulation sites using multimodal neuroimaging and electric field modeling and then check their response to stimulation. If they show MRI response to stimulation and it is well-tolerated, they will be eligible to receive 30 hours of training (one hour, twice daily), with active or sham tDCS during one of the daily sessions Primary outcomes are the Scale for Assessment and Rating of Cerebellar Ataxia (SARA) and Patient-Reported Outcome Measure of Ataxia (PROM-Ataxia), assessed pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
This research addresses a critical gap in treatment options for cerebellar ataxia by testing whether personalized neuromodulation enhances rehabilitation outcomes.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Anthony J Gonzalez, BS
- 电话号码：443-923-2716
- 邮箱：gonzalezan@kennedykrieger.org
研究联系人备份
- 姓名：Derek J Eversley, BS
- 电话号码：443-923-2716
- 邮箱：eversley@kennedykrieger.org
学习地点
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Maryland
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Baltimore、Maryland、美国、21205
- 招聘中
- Motion Analysis Lab in the Kennedy Krieger Institute
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接触：
- Anthony J Gonzalez, BS
- 电话号码：443-923-2716
- 邮箱：gonzalezan@kennedykrieger.org
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首席研究员：
- Amy J Bastian, PhD, PT
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age 18-75 years
- Males and Females
- Disorders that predominantly affect the cerebellum: damage from stroke, tumor or degeneration (genetic or non-genetic causes, congenital hypoplasia).
Exclusion Criteria:
- Diagnoses or impairments that interfere with task execution or data interpretation.
- Heart pacemaker or other MRI-incompatible implanted metal device
- Metallic foreign body in their eye or head
- Experience with severe claustrophobia
- Experience discomfort from the MRI scan, such as excessive heating of tattoos
- Seizures or history of seizure disorder
- Alcohol or substance use disorder (self-report)
- Diagnosed history of severe psychiatric disorder such as depression, schizophrenia (self-report)
- Metallic foreign body in their eye or head (except the mouth e.g. dental fillings)
- Specific medications: tricyclic anti-depressants or neuroleptic medication
- Any medical condition (including orthopedic, pain, cardiopulmonary or other) that limits safe participation in exercise training
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active stimulation combined with therapy.
Once a stimulation site is determined, subjects will receive 20 minutes of active tDCS stimulation daily.
Subjects will also receive one hour of therapy, twice daily.
Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility.
Subjects will complete up to 30 therapy sessions.
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Each participant will choose a domain that they would like to focus on.
Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
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假比较器：Sham stimulation combined with therapy.
Once a stimulation site is determined, subjects will receive 20 minutes of sham tDCS stimulation daily.
Subjects will also receive one hour of therapy, twice daily.
Therapy will be individualized to each subject and, will encompass three domains; 1) walking and balance control, 2) hand dexterity and arm control, 3)speech articulation, prosody, and intelligibility.
Subjects will complete up to 30 therapy sessions.
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Each participant will choose a domain that they would like to focus on.
Choices are: 1) walking and balance control, 2) hand dexterity and arm control, or 3) speech articulation, prosody, and intelligibility.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Scale for the Assessment and Rating of Ataxia (SARA)
大体时间：Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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The SARA is a tool for assessing ataxia.
SARA is an 8-item performance based scale, yielding a total score of 0 (no ataxia) to 40 (most severe ataxia).
The scores are based on patient performance of: gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, heel-shin slide.
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Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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Patient-Reported Outcome Measure of Ataxia
大体时间：Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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The PROM-Ataxia is a self reported questionnaire used by researchers to evaluate the daily impact and progression of cerebellar ataxia directly from the patient's perspective.
The questionnaire encompasses 70 total items within 3 main domains: 1) Physical: Gait, manual dexterity, swallowing (dysphagia), and visual/ocular motor control.
2) Activities of Daily Living (ADL): Managing household chores, employment, driving, and self-care.
3)Mental: Mood, anxiety, motivation, and cognitive tasks (e.g., multitasking and comprehension).
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Assessed at pre-treatment, post-treatment, and at 3- and 6-month follow-ups.
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合作者和调查者
调查人员
- 首席研究员：Amy J Bastian, PhD, PT、Motion Analysis Lab in the Kennedy Krieger Institute
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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