Clinical trial NCT02542982: tDCS and Motor Training and Motor Deficit After Stroke
Official title: Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stroke
Keywords: tDCS
motor recovery
Lead sponsor: Military Medical Academy, Belgrade, Serbia
Sponsor class: OTHER
Collaborators: name: Clinical Centre of Serbia
First posted: 2015-09-07
Enrollment: 26
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Jebsen Taylor Test of Hand Function
timeFrame: one day, two weeks and one month
Secondary outcomes:
measure: hand grip force
timeFrame: two weeks and one month
measure: upper limb Fugl-Meyer assessment of Motor Recovery after Stroke
timeFrame: one day, two weeks and one month
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic of Neurology, Military Medical Academy, Belgrade
Study officials:
affiliation: Military Medical Academy, Serbia
name: Tihomir V Ilic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: