tDCS and Motor Training and Motor Deficit After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 3
Locations
Serbia
Study Type
Interventional
Intervention
tDCS (Endomed 482; Enraf-Nonius B.V.)
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring tDCS, motor recovery
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
Sites / Locations
- Clinic of Neurology, Military Medical Academy, Belgrade
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active treatment
Sham comparator
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
hand grip force
changes of baseline maximum grip force of the hand measured by whole-hand dynamometer
upper limb Fugl-Meyer assessment of Motor Recovery after Stroke
changes of initial score from domain of motor functions for upper limb
Full Information
NCT ID
NCT02542982
First Posted
March 21, 2015
Last Updated
September 3, 2015
Sponsor
Military Medical Academy, Belgrade, Serbia
Collaborators
Clinical Centre of Serbia
1. Study Identification
Unique Protocol Identification Number
NCT02542982
Brief Title
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
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military Medical Academy, Belgrade, Serbia
Collaborators
Clinical Centre of Serbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
tDCS, motor recovery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Experimental
Arm 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.
Arm Title
Sham comparator
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
tDCS (Endomed 482; Enraf-Nonius B.V.)
Intervention Description
non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered
Primary Outcome Measure Information:
Title
Jebsen Taylor Test of Hand Function
Description
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 Outcome Measure Information:
Title
hand grip force
Description
changes of baseline maximum grip force of the hand measured by whole-hand dynamometer
Time Frame
two weeks and one month
Title
upper limb Fugl-Meyer assessment of Motor Recovery after Stroke
Description
changes of initial score from domain of motor functions for upper limb
Time Frame
one day, two weeks and one month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tihomir V Ilic, MD, PhD
Organizational Affiliation
Military Medical Academy, Serbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of Neurology, Military Medical Academy, Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Learn more about this trial
tDCS and Motor Training and Motor Deficit After Stroke
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