Effect of ctDCS During Balance Training on Cerebellar Ataxia

NCT04039048 | Unknown

• 1 other identifier: cerebellarataxia_balance_ctDCS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebellar Ataxia; Cerebellum; Injury; Balance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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 Arms (2)

ctDCS during Balance training

EXPERIMENTAL

Device: cerebellar transcranial direct current stimulation; Other: Balance training

ctDCS sham during Balance training

SHAM COMPARATOR

Device: Sham cerebellar transcranial direct current stimulation; Other: Balance training

Interventions

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.

Also known as: ctDCS

ctDCS during Balance training

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.

Also known as: ctDCS sham

ctDCS sham during Balance training

Balance training OTHER

Balance training will be performed through the Biodex Balance System for 20 minutes.

ctDCS during Balance training; ctDCS sham during Balance training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cerebellar ataxia
• Score \> 1 ≤ 4 on posture of Scale for assessment and rating of ataxia

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Kátia Monte-Silva

Recife, Pernambuco, 50670-901, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 38693314 DERIVED

MeSH Terms

Conditions

Cerebellar Ataxia; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Kátia Monte-Silva, PhD

CONTACT

+55 81 2126-7579; monte.silvakk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study director

Study Record Dates

• First Submitted: July 28, 2019
• First Posted: July 31, 2019
• Study Start: September 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: March 1, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Locations

BR (1)