Cerebellar Non-invasive Stimulation in Ataxias

Study Overview
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Brief Summary
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Cerebellar ataxias are a group of disorders caused by cerebellar affections, for which currently no specific treatment is available. Some limited studies verified the effects of cerebellar transcranial magnetic stimulation (TMS) on ataxic symptoms, with good results. So far it is not known which patients could benefit. Our hypothesis is that cerebellar TMS could improve ataxic symptoms in some patients.

Detailed Description
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Thirty patients with cerebellar ataxia will be included in our protocol. Ataxia might be due to several aetiologies, from degenerative to genetic and vascular diseases. Patients will be submitted to a neuronavigation protocol for the precise location of the dentate nucleus contralateral to the most symptomatic side. After that, participants will be randomly assigned to 5 active or 5 placebo sessions of 1Hz TMS over the located area. After the first 5 sessions and a period of at least 4 weeks washout, patients will cross over and receive other 5 sessions, active or sham. Clinical and video evaluations will be conducted before and after active and sham cluster of sessions.

Official Title
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Effects of Cerebellar Transcranial Magnetic Stimulation in Cerebellar Ataxias

Conditions
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Cerebellar Ataxia

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation (TMS)
* Device: Sham Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: identification of cerebellar ataxia based on neurologic examination no improvement after rehabilitation symptoms onset of at least 6 months Exclusion Criteria: Younger than 18 months Pregnant or breastfeeding women Participation in other clinical trials Epilepsy

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 5 sessions of active and sham rTMS separated by at least 4 weeks washout.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transcranial Magnetic Stimulation (TMS) Stimulation<br>All patients will receive 5 sessions of active TMS stimulation. | Device: Transcranial Magnetic Stimulation (TMS)<br>* Low frequency (1Hz) transcranial magnetic stimulation aimed to the dentate nucleus contralateral to the most symptomatic side.<br>|
| Sham Comparator: Sham Stimulation<br>All patients will receive 5 sessions of active TMS stimulation | Device: Sham Stimulation<br>* The stimulation coil will be placed in the same spot as the TMS stimulation, but coil will not be attached to the TMS machine.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA) | Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance. | Day 1 (baseline), day 5 (after 5th TMS session, active or sham), day 33 (new baseline after TMS wash out) and day 38 (after 10th TMS session, active or sham) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMS, Transcranial Magnetic Stimulation, Cerebellar Ataxia