Effect of ctDCS During Balance Training on Cerebellar Ataxia

NCT ID: NCT04039048

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebellar Ataxia Cerebellum; Injury Balance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ctDCS during Balance training

Group Type EXPERIMENTAL

cerebellar transcranial direct current stimulation

Intervention Type 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.

Balance training

Intervention Type OTHER

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

ctDCS sham during Balance training

Group Type SHAM_COMPARATOR

Sham cerebellar transcranial direct current stimulation

Intervention Type 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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Balance training

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

Intervention Type OTHER

Other Intervention Names

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ctDCS ctDCS sham

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal de Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Kátia Monte-Silva

Study director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kátia Monte-Silva

Recife, Pernambuco, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Kátia Monte-Silva, PhD

Role: CONTACT

+55 81 2126-7579

Facility Contacts

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Kátia Monte-Silva, PhD

Role: primary

+55 81 2126-7579

References

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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.

Reference Type DERIVED
PMID: 38693314 (View on PubMed)

Other Identifiers

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cerebellarataxia_balance_ctDCS

Identifier Type: -

Identifier Source: org_study_id

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