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

Phase 2

• Conditions: Transcranial Direct Current Stimulation; Electromyography; Hemiparesis
• Interventions: Device: Sham stimulation; Device: Transcranial direct current stimulation (tDCS); Device: Functional electrical stimulation (FES)

• Registration Number: NCT03008720
• Lead Sponsor: University of Nove de Julho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-30
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-01
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-04
• Study Start: 2017-02
• Primary Completion: 2017-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FES sham	Sham stimulation	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.
tDCS active	Transcranial direct current stimulation (tDCS)	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.
tDCS sham	Sham stimulation	Placebo tDCS will follow the same procedures as active tDCS with active, but the tDCS device will only be switched on for 20 seconds.
FES active	Functional electrical stimulation (FES)	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.

Primary Outcome Measures

Name	Time	Method
electrical activity (median frequency and amplitude of the electromyographic signal) of the anterior tibial muscle	1 YEAR