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Clinical Trials/NCT04039048
NCT04039048
Unknown
Not Applicable

Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia

Universidade Federal de Pernambuco1 site in 1 country10 target enrollmentSeptember 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebellar Ataxia
Sponsor
Universidade Federal de Pernambuco
Enrollment
10
Locations
1
Primary Endpoint
Change in balance
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2019
End Date
March 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kátia Monte-Silva

Study director

Universidade Federal de Pernambuco

Eligibility Criteria

Inclusion Criteria

  • Cerebellar ataxia
  • Score \> 1 ≤ 4 on posture of Scale for 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 (3 months) during the period of study

Outcomes

Primary Outcomes

Change in balance

Time Frame: 5 minutes before the intervention and 10 minutes after the intervention

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.

Secondary Outcomes

  • Change in Ataxia' severity(10 minutes before the intervention and 15 minutes after the intervention)
  • Change in functional mobility(15 minutes before the intervention and 20 minutes after the intervention)

Study Sites (1)

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