Effect of ctDCS During Balance Training on Cerebellar Ataxia

• ClinicalTrials.gov Identifier: NCT04039048
• Recruitment Status: Recruiting
• First Posted: July 31, 2019
• Last Update Posted: August 16, 2019
• Sponsor: Universidade Federal de Pernambuco
• Information provided by (Responsible Party): Kátia Monte-Silva, Universidade Federal de Pernambuco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cerebellar Ataxia; Cerebellum; Injury; Balance	Device: cerebellar transcranial direct current stimulation; Device: Sham cerebellar transcranial direct current stimulation; Other: Balance training	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Cerebellar Transcranial Direct Current Stimulation During Balance Training on Cerebellar Ataxia
• Estimated Study Start Date: September 2019
• Estimated Primary Completion Date: February 2020
• Estimated Study Completion Date: March 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: ctDCS during Balance training	Device: cerebellar transcranial direct current stimulation; 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.; Other Name: ctDCS; Other: Balance training; Balance training will be performed through the Biodex Balance System for 20 minutes.
Sham Comparator: ctDCS sham during Balance training	Device: Sham cerebellar transcranial direct current stimulation; 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.; Other Name: ctDCS sham; Other: Balance training; Balance training will be performed through the Biodex Balance System for 20 minutes.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Change in Ataxia' severity [ Time Frame: 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.
2. Change in functional mobility [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Kátia Monte-Silva, PhD; +55 81 2126-7579; monte.silvakk@gmail.com

Locations

Brazil

Kátia Monte-Silva; Recruiting

Recife, Pernambuco, Brazil, 50670-901

Contact: Kátia Monte-Silva, PhD +55 81 2126-7579 monte.silvakk@gmail.com

Sponsors and Collaborators

Universidade Federal de Pernambuco

More Information

• Responsible Party: Kátia Monte-Silva, Study director, Universidade Federal de Pernambuco
• ClinicalTrials.gov Identifier: NCT04039048 History of Changes
• Other Study ID Numbers: cerebellarataxia_balance_ctDCS
• First Posted: July 31, 2019
• Last Update Posted: August 16, 2019
• Last Verified: August 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kátia Monte-Silva, Universidade Federal de Pernambuco:

Biodex balance system; Posture control; Ataxia' severity; ctDCS

Additional relevant MeSH terms:

Ataxia; Cerebellar Ataxia; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases