tDCS and Motor Training and Motor Deficit After Stroke

Stroke Clinical Trial

Official title:

Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02542982
• Other study ID #: MFVMA/12/13-15
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2015
• Last updated: September 3, 2015
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Military Medical Academy, Belgrade, Serbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS (Endomed 482; Enraf-Nonius B.V.)
non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered

Locations

Country	Name	City	State
Serbia	Clinic of Neurology, Military Medical Academy, Belgrade	Belgrade

Sponsors (2)

Lead Sponsor	Collaborator
Military Medical Academy, Belgrade, Serbia	Clinical Centre of Serbia

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one day, two weeks and one month	No
Secondary	hand grip force	changes of baseline maximum grip force of the hand measured by whole-hand dynamometer	two weeks and one month	No
Secondary	upper limb Fugl-Meyer assessment of Motor Recovery after Stroke	changes of initial score from domain of motor functions for upper limb	one day, two weeks and one month	No