tDCS Associated With Locomotor Training on Functional Mobility of Cerebellar Ataxia

NCT03703830 | Active Not Recruiting

• 1 other identifier: Cerebellarataxia_ctDCS_LT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cerebellum; Transcranial direct current stimulation; Gait ataxia

Outcome Measures

Primary Outcomes (1)

• Change in Functional mobility

  The evaluation of the functional mobility of individuals will be performed by the Timed Up and Go test. It will analyze the time spent by the individual to get up from a chair with arms, walk for three meters and return to the chair. Longer times to performe the Timed Up and Go test mean worse functional mobility.

  Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day

Secondary Outcomes (5)

• Change in Fall risk

  Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.

• Change in Ataxia severity

  Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.

• Change in Balance

  Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day.

• Change in Patient global impression

  Change from baseline (T0) at 7 (T7) and 14 days (T14) after the first intervention's day

• Adverse effects of ctDCS

  25 minutes after the beginning of stimulation

Study Arms (4)

Experimental I

EXPERIMENTAL

Cerebellar transcranial current stimulation associated with locomotor training

Device: Cerebellar transcranial direct current stimulation; Other: Treadmill locomotor training

Sham comparator I

SHAM COMPARATOR

Cerebellar transcranial current stimulation sham associated with locomotor training

Other: Treadmill locomotor training; Device: Sham Cerebellar transcranial direct current stimulation

Experimental II

EXPERIMENTAL

Cerebello-spinal direct current stimulation associated with locomotor training

Other: Treadmill locomotor training; Device: Cerebello-spinal direct current stimulation

Sham comparator II

SHAM COMPARATOR

Cerebello-spinal direct current stimulation sham associated with locomotor training

Other: Treadmill locomotor training; Device: Sham cerebello-spinal direct current stimulation

Interventions

Cerebellar transcranial direct current stimulation DEVICE

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.

Experimental I

Treadmill locomotor training OTHER

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

Experimental I; Experimental II; Sham comparator I; Sham comparator II

Sham Cerebellar transcranial direct current stimulation DEVICE

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.

Sham comparator I

Cerebello-spinal direct current stimulation DEVICE

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)

Experimental II

Sham cerebello-spinal direct current stimulation DEVICE

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.

Sham comparator II

Eligibility Criteria

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

You may qualify if:

• 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

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 during the period of study

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Kátia Monte-Silva

Recife, Pernambuco, 50670-901, Brazil

Location

MeSH Terms

Conditions

Cerebellar Ataxia; Gait Ataxia

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; Gait Disorders, Neurologic

Study Design

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

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 12, 2018
• Study Start: November 1, 2018
• Primary Completion: March 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

BR (1)