rTMS Improves Functions in Spinocerebellar Ataxia

Study Overview
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Brief Summary
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Spinocerebellar ataxia (SCA) is a group of inherited brain disorders. SCA often result in poor limb coordination. This study aims to discover the effects of repeated transcranial magnetic stimulation (rTMS) on balance & gait in SCA. The hypothesis of this study is that rTMS might improve SCA limb functional performance.

Detailed Description
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rTMS has been shown that improves walking speed and balance performance, however, the optimal treatment protocols have not been approved. Past studies used different frequencies 1 Hz, 5 Hz and 10 Hz to improve functional performance. The results might be affected by the types of SCA. In this study, we will focus on the SCA type 3 to assess the effects on high frequency (10 Hz) of rTMS intervention.

Official Title
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Repetitive Transcranial Magnetic Stimulation Improves Functional Performance in Spinocerebellar Ataxia

Conditions
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Transcranial Magnetic Stimulation, Spinocerebellar Ataxias

Intervention / Treatment
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* Device: Repetitive Transcranial Magnetic Stimulation (rTMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SCA type 3 independently walk with/without an assistive device SARA greater than 3 Exclusion Criteria: Epilepsy history Unstable blood pressure Brain Trauma Alcoholism, drug abuse, antipsychotics drug use Metallic hardware (e.g. - cochlear implants, brain stimulators or electrodes, aneurysm clips) anywhere in head. Dementia, depression

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects receive 12 times rTMS intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS with 10 Hz<br>6 times/per week for 2 weeks, total 12 times rTMS. | Device: Repetitive Transcranial Magnetic Stimulation (rTMS)<br>* 6 times/per week for 2 weeks, total 12 times rTMS with 10 Hz.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of International Cooperative Ataxia Rating Scale | International Cooperative Ataxia Rating Scale (ICARS): quantify the level of impairment as a result of ataxia as related to hereditary ataxias. Disorders rated as subscales within the ICARS are: Postural and gait disturbances, Limb Ataxia, Dysarthria, and Oculomotor disorders.It translates the symptomatology of cerebellar ataxia into a scoring system out of 100. | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 
| Changes of SARA | Scale for the Assessment and Rating of Ataxia (SARA): a tool for assessing ataxia. It has eight categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 
| Changes of Berg Balance Scale | Berg Balance Scale (BBS): a widely used assessment to determine a person's balance abilities. The test contains 14 simple tasks, scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. The entire process takes about 20 minutes to complete. | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 
| Changes of Timed up and go | Timed up and go (TUG): Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 
| Changes of Center of pressure trajectory | Center of pressure (COP): he trajectory of the COP, commonly known as a stabilogram, during static balance is frequently used to measure postural control. When standing still on a force platform, the COP is thought to be an indicator of the motor mechanisms involved in maintaining balance with opened-eyes or closed-eyes. Two trials for each condition were performed within 5 minutes. | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 
| Changes of Kinematic of Gait | The joint angles of hip, knee, ankle are collected during walking in a 10 meters walkway. | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 
| Changes of Electromyography of Gait | A wireless surface Electromyography (EMG) is used to collect lower extremities muscle activation signals during walking in a walkway. | Baseline (T0), 6 days after first rTMS intervention (T1), 12 days after first rTMS intervention (T2), | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Neurofilament | neurofilament proteins is the biomarkers of axonal damage in diseases affecting the central nervous system | Baseline (T0), 12 days after first rTMS intervention (T2) | 
| Changes of Mini-mental state examination | The mini-mental state examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment. In this study, it is used to rule out subjects who might have dementia. | Baseline (T0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rTMS, SCA