Effect of ctDCS During Balance Training on Cerebellar Ataxia

Not Applicable

• Conditions: Balance; Cerebellar Ataxia; Cerebellum; Injury
• Interventions: Device: cerebellar transcranial direct current stimulation; Device: Sham cerebellar transcranial direct current stimulation; Other: Balance training

• Registration Number: NCT04039048
• Lead Sponsor: Universidade Federal de Pernambuco

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-28
• Study First Posted: 2019-07-31
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-16
• Study Start: 2019-09
• Primary Completion: 2020-02
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ctDCS during Balance training	cerebellar transcranial direct current stimulation	-
ctDCS during Balance training	Balance training	-
ctDCS sham during Balance training	Sham cerebellar transcranial direct current stimulation	-
ctDCS sham during Balance training	Balance training	-

Primary Outcome Measures

Name	Time	Method
Change in balance	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 Outcome Measures

Name	Time	Method
Change in Ataxia' severity	10 minutes before the intervention and 15 minutes after the intervention	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.
Change in functional mobility	15 minutes before the intervention and 20 minutes after the intervention	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.

Trial Locations

Locations (1)

Kátia Monte-Silva; 🇧🇷 Recife, Pernambuco, Brazil