tDCS and Motor Training and Motor Deficit After Stroke

Military Medical Academy, Belgrade, Serbia

Status and phase: Completed; Phase 3

Conditions: Stroke

Treatments: Device: tDCS (Endomed 482; Enraf-Nonius B.V.)

Study type: Interventional

Funder types: Other

Identifiers

NCT02542982

MFVMA/12/13-15

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 26 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

Active treatment

Experimental group

Description:

Group of patients on active treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by 20 minutes of 2 mA anodal tDCS over the ipsilesional motor cortex.

Treatment:

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

Sham comparator

Sham Comparator group

Description:

Group of patients on sham treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by sham tDCS over the ipsilesional motor cortex.

Treatment:

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