tDCS and Motor Training and Motor Deficit After Stroke

Military Medical Academy, Belgrade, Serbia26 enrolled

Overview

This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.

A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence. This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients. Patients with chronic hand motor deficits after stroke (\> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS. Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

Interventions

tDCS (Endomed 482; Enraf-Nonius B.V.)DEVICE

non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans * stroke duration \> 12 months * severe hand deficit at stroke onset (Medical Research Council grade \<2) and * subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts), * spasticity between 0-2 assessed on the Modified Ashworth Scale Exclusion Criteria: * any clinically significant or unstable medical disorder, * diagnosis od major depression, * diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination \< 24). * any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants

Locations (1)

Clinic of Neurology, Military Medical Academy, Belgrade

Belgrade, Serbia

Outcomes

Primary Outcomes

Jebsen Taylor Test of Hand Function

changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately

Time frame: one day, two weeks and one month

Secondary Outcomes

hand grip force

changes of baseline maximum grip force of the hand measured by whole-hand dynamometer

Time frame: two weeks and one month

upper limb Fugl-Meyer assessment of Motor Recovery after Stroke

changes of initial score from domain of motor functions for upper limb

Time frame: one day, two weeks and one month

Data from ClinicalTrials.gov

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