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Cerebellar ataxia is a neurologic symptom caused by damage or dysfunction in the cerebellum and its pathways that results in loss of coordination, balance and postural control. There is a high rate (93%) of fallings for this population that could limit daily life activities. Pharmacological interventions are not able to modify the balance, therefore, new approaches to rehabilitate must be studied. ctDCS is a non-invasive brain stimulation that seems to be a new and innovator technique to restore ataxia symptoms. The purpose of this study is to evaluate the effects of ctDCS associated with balance training on cerebellar ataxia patients. A counterbalanced crossover, sham-controlled, triple blind trial will be performed. All subjects will receive the real and sham ctDCS associated to balance training. The anodal ctDCS (2 mA, 20 minutes) or sham (2mA, 30 seconds) will be applied during balance training at Biodex Balance System (BBS). The balance will be the primary outcome and will be evaluated through Posture Control at Biodex Balance System. Ataxia' severity and functional mobility will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA) and 10 meters walking test, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ctDCS during Balance training | Experimental |
| |
| ctDCS sham during Balance training | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cerebellar transcranial direct current stimulation | Device | Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 20 minutes with a 2mA current. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in balance | The change in balance will be assessed through postural control index of Biodex Balance System. This postural control index is a continuous variable where lower index means less instability and better balance. | 5 minutes before the intervention and 10 minutes after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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 higher score (40) mean more severe ataxia, whereas lower score (0) means less ataxia symptoms. The score happens about the sum of the eight items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kátia Monte-Silva, PhD | Contact | +55 81 2126-7579 | monte.silvakk@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kátia Monte-Silva | Recruiting | Recife | Pernambuco | 50670-901 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38693314 | Derived | Brito R, Fabricio JV, Araujo A, Barreto G, Baltar A, Monte-Silva K. Single-Session Cerebellar Transcranial Direct Current Stimulation Improves Postural Stability and Reduces Ataxia Symptoms in Spinocerebellar Ataxia. Cerebellum. 2024 Oct;23(5):1993-2002. doi: 10.1007/s12311-024-01696-9. Epub 2024 May 2. |
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| ID | Term |
|---|---|
| D002524 | Cerebellar Ataxia |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham cerebellar transcranial direct current stimulation | Device | Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 30 seconds with a 2mA current. |
|
|
| Balance training | Other | Balance training will be performed through the Biodex Balance System for 20 minutes. |
|
| 10 minutes before the intervention and 15 minutes after the intervention |
| Change in functional mobility | The patient will walk 10 meters and the time will be measured to determine the functional mobility. Where lower time to walk 10 meters, better functional mobility. | 15 minutes before the intervention and 20 minutes after the intervention |
| D001259 | Ataxia |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |