tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

Universidade Federal de Pernambuco

Status: Active, not recruiting

Conditions: Ataxia, Cerebellar

Treatments: Device: Cerebellar transcranial direct current stimulation; Device: Sham Cerebellar transcranial direct current stimulation; Device: Cerebello-spinal direct current stimulation; Device: Sham cerebello-spinal direct current stimulation; Other: Treadmill locomotor training

Study type: Interventional

Funder types: Other

Identifiers

NCT03703830

Cerebellarataxia_ctDCS_LT

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebellar ataxia
• Ages: 18 to 65 years;
• Gender: Both;
• Score ≥ 3 and < 8 in subscore of gait in the Scale for the 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 during the period of study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups

Experimental I

Experimental group

Description:

Cerebellar transcranial current stimulation associated with locomotor training

Treatment:

Other: Treadmill locomotor training

Device: Cerebellar transcranial direct current stimulation

Sham comparator I

Sham Comparator group

Description:

Cerebellar transcranial current stimulation sham associated with locomotor training

Treatment:

Device: Sham Cerebellar transcranial direct current stimulation

Other: Treadmill locomotor training

Experimental II

Experimental group

Description:

Cerebello-spinal direct current stimulation associated with locomotor training

Treatment:

Other: Treadmill locomotor training

Device: Cerebello-spinal direct current stimulation

Sham comparator II

Sham Comparator group

Description:

Cerebello-spinal direct current stimulation sham associated with locomotor training

Treatment:

Other: Treadmill locomotor training

Device: Sham cerebello-spinal direct current stimulation