Evaluation of Electrical Activity Tibial Muscle and Postural Control of Individuals With Hemiparesia Post TDCS Associated With FES

NCT03008720 | Unknown Phase 2

• 1 other identifier: 767.866
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: It is suggested that increased cortical activity, induced by cerebral stimulation associated or not with other rehabilitation techniques, may potentiate the motor and functional therapeutic effects in individuals with neurological deficits. Objectives: To evaluate the electrical activity of the anterior tibial muscle (TA) and postural control of individuals with hemiparesis due to stroke following treatment with transcranial direct current (tDCS) stimulation and functional electrical stimulation (FES), associated or isolated). (EMG) and postural control by the Balance Evaluation Systems Test (BESTest). Both of which were collected at four different time points: pre-treatment, immediately after 10 treatment sessions, and 30 days follow-up after the interventions. Patients will be randomized into 4 experimental groups: tDCS anodic active + active FES+ active contraction TA, tDCS sham + active FES+ active contraction TA, tDCS anodic active+ placebo FES+ active contraction TA, tDCS sham+ FES sham+ active contraction TA. tDCS (2mA) will be applied over the motor (Cz) and cathodic vertex over the supraorbital region of the normal hemisphere and FES over hemiparetic TA by a researcher who will not be the one who will evaluate the anesthesia patient. The treatment will last 10 sessions, twice a week, with a time of 20 minutes.

Conditions

Hemiparesis; Transcranial Direct Current Stimulation; Electromyography

Keywords

functional electrical simulation

Outcome Measures

Primary Outcomes (1)

• electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle

  1 YEAR

Study Arms (4)

tDCS active

ACTIVE COMPARATOR

Transcranial stimulation ( tDCS ) active will be administered using Tct Research 1 CH tdcs Simulator model 101. tDCS will be performed for 20 minutes and intensity 2mA associated active contraction of the TA muscle.

Device: Transcranial direct current stimulation (tDCS)

tDCS sham

PLACEBO COMPARATOR

Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.

Device: Sham stimulation

FES active

ACTIVE COMPARATOR

Functional electrical stimulation (FES) active will be administered using QUARK® FES VIF 995 DUAL device. The duration of active FES will be 20 minutes, associated with active contraction of the TA muscle. The pulse width will be 250 μs, modulated at a frequency of 50 Hz, with one to two stimulation cycles (6 seconds on and 12 seconds off) and the intensity will be increased until reaching the motor threshold.

Device: Functional electrical stimulation (FES)

FES sham

PLACEBO COMPARATOR

Placebo FES will follow the same procedures as active FES , but the FES device will only be switched on for 20 seconds, following which the intensity will be gradually reduced to 0 mA.

Device: Sham stimulation

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

tDCS active

Functional electrical stimulation (FES) DEVICE

FES active

Sham stimulation DEVICE

FES sham; tDCS sham

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with hemiparesis due to stroke;
• Both sexes;
• Agree to sign the free and informed consent form.

You may not qualify if:

• Positive cut-off point for the Mini Mental State Examination (MMSE) of less than 11 points already corrected for schooling;
• Ankle mobility reduced by history of fracture or use of ankle fasteners;
• Irreducible equine deformity;
• Muscle strength level of AT less than 1 by the scale of Kendall;
• Patients with reported severe visual impairment;
• Contraindications to the use of transcranial direct current stimulation (history of seizure or recurrent epilepsy, brain tumors at the stimulation site, metallic materials implanted in the brain);
• Individuals with cutaneous infection at the point of application of FECC or FES;
• Individuals who presented anesthesia or hyperesthesia at the point of application of the ECTS;
• Individuals diagnosed with deep venous thrombosis (DVT);
• Individuals diagnosed with degenerative diseases or polyneuropathies.
• Individuals who do not present complementary tests that diagnose the lesion site.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Paresis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of graduation.

Study Record Dates

• First Submitted: December 28, 2016
• First Posted: January 2, 2017
• Study Start: February 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2018
• Last Updated: January 4, 2017

Record last verified: 2017-01