tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

Summary

Cerebellar ataxia is a neurologic symptom caused by a damage or a dysfunction in cerebellum and results in loss of coordination, balance and postural control. This impairment could result in a reduction of walking speed, short and irregular steps and difficulty in coordinating between lower limbs. Pharmacological interventions are not able to modify ataxia gait pattern, therefore, new approaches to rehabilitate must be studied. Treadmill locomotor training (TLT) and cerebellar transcranial direct current stimulation (ctDCS) are physical therapy techniques able to module cerebellar afferences and modify positively ataxia gait pattern. However, there is no study involving the association of these two techniques. The purpose of this study is to evaluate the effects of ctDCS associated to TLT on functional mobility in subjects with cerebellar ataxia. A randomized, sham controlled, double blind clinical trial will be performed. The subjects will be randomly allocated into two groups: (i) ctDCS associated with TLT; (ii) ctDCS sham associated with TLT. The TLT will be performed with a speed and step length progression protocol for 25 minutes. The anodal ctDCS (2 mA, 25 minutes) or sham (2mA, 30 seconds) will be applied during TLT. The functional mobility will be the primary outcome and will be evaluated through timed up and go test (TUG). Ataxia' severity, balance and fall risky, will be the secondary outcomes and will be evaluated by the scale for the assessment and rating of ataxia (SARA), balance evaluation system test (miniBest) and TUG, respectively.

Conditions

• Ataxia, Cerebellar

Interventions

DEVICE

Cerebellar transcranial direct current stimulation

Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle.

OTHER

Treadmill locomotor training

The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS

DEVICE

Sham Cerebellar transcranial direct current stimulation

Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.

DEVICE

Cerebello-spinal direct current stimulation

Cerebello-spinal transcranial direct current stimulation (csDCS) will be applied during 25 minutes at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11)

DEVICE

Sham cerebello-spinal direct current stimulation

Sham cerebello-spinal direct current stimulation (csDCS sham) will be applied during 30 seconds at 2 mA of intensity. The anode was placed on the scalp over the cerebellum area (1 cm below the inion) and the cathode over the spinal lumbar enlargement (2 cm under T11). However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.

Sponsors & Collaborators

• Universidade Federal de Pernambuco

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2024-03-31

Completion

2024-07-31

Countries

• Brazil

Study Locations