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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental I | Experimental | Cerebellar transcranial current stimulation associated with locomotor training |
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| Sham comparator I | Sham Comparator | Cerebellar transcranial current stimulation sham associated with locomotor training |
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| Experimental II | Experimental | Cerebello-spinal direct current stimulation associated with locomotor training |
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| Sham comparator II | Sham Comparator | Cerebello-spinal direct current stimulation sham associated with locomotor training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebellar transcranial direct current stimulation | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kátia Monte-Silva | Recife | Pernambuco | 50670-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41996751 | Derived | Brito R, Lima FA, Ribeiro AC, Fabricio JV, Melo D, Guerra S, Sacchi M, Barreto G, Baltar A, Tanaka C, Monte-Silva K. Brief protocol to improve ataxia symptoms via cerebello-spinal direct current stimulation during gait training. Clin Neurophysiol. 2026 Jul;187:2111882. doi: 10.1016/j.clinph.2026.2111882. Epub 2026 Apr 3. |
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| Treadmill locomotor training | Other | The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS |
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| Sham Cerebellar transcranial direct current stimulation | Device | 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. |
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| Cerebello-spinal direct current stimulation | Device | Cerebello-spinal transcranial direct current stimulation (csDCS) will be applied during 25 minutes at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11) |
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| Sham cerebello-spinal direct current stimulation | Device | Sham cerebello-spinal direct current stimulation (csDCS sham) will be applied during 30 seconds at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11). However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking. |
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| 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 |
| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| D020234 | Gait Ataxia |
| ID | Term |
|---|---|
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020233 | Gait Disorders, Neurologic |
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