tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

Study Overview
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Brief Summary
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Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.

Official Title
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Effects of Cerebellar Transcranial Current Stimulation Associated With Locomotor Training on Functional Mobility of Subjects With Cerebellar Ataxia

Conditions
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Ataxia, Cerebellar

Intervention / Treatment
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* Device: Cerebellar transcranial direct current stimulation
* Other: Treadmill locomotor training
* Device: Sham Cerebellar transcranial direct current stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cerebellar ataxia Ages: 18 to 65 years; Gender: Both; Score ≥ 3 and < 8 in subscore of gait in the Scale for the Assessment and Rating of Ataxia Exclusion Criteria: Individuals with other neurological disorders, postural hypotension, vestibular, visual, cardiovascular or musculoskeletal disorders that affect the performance of the proposed tests; Pacemaker; History of seizures; Metallic implants in the head or neck; Medication change during the period of study

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Cerebellar transcranial current stimulation associated with locomotor training | Device: Cerebellar transcranial direct current stimulation<br>* Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle.<br>Other: Treadmill locomotor training<br>* The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS<br>|
| Sham Comparator: Sham comparator<br>Cerebellar transcranial current stimulation sham associated with locomotor training | Other: Treadmill locomotor training<br>* The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS<br>Device: Sham Cerebellar transcranial direct current stimulation<br>* Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional mobility | The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility. | Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fall risk | The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer time values and step numbers represent a greater risk of falls. Time greater than 10 seconds in the test means greater risk of falling. | Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. | 
| Change in Ataxia severity | The ataxia' severity will be assessed by the Scale for the Assessment and Rating of Ataxia (SARA). It consists of eight items (gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating, hand movements, and heel-shin slide), where ranges from 0 to 40. Higher score mean more severe ataxia. | Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. | 
| Change in Balance | The balance of individuals will be assessed through the Balance Evaluation System Test (BESt), which comprises 14 items with a score of 0-2 each from 0 (worst) to 2 (best performance), used to assess dysfunction in balance and independence in life activities daily. | Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day. | 
| Change in Patient global impression | The patient's global impression is a questionnaire which the patient has to answer how the treatment changed his life daily activities. Patient will choose the best option that reflects their improvement in quality of life, from no change to much better with differences that have made all the difference. | Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day | 
| Adverse effects of ctDCS | Brunoni's questionnaire will be used to ask the patient about some possible adverse effects related to stimulations. The patient will be asked always at the end of each stimulation (real or sham). | 25 minutes after the beginning of stimulation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebellum, Transcranial direct current stimulation, Gait ataxia