Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2013-04-30
2015-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke
NCT04059848
The Influence of tDCS on the Arm and Hand Function in Stroke Patients
NCT02210403
Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery
NCT00792428
Rehabilitation Combined With Bihemispherictranscranial Direct Current Stimulation in Subacute Ischemic Stroke
NCT01644929
Dual-tDCS and Anodal PMC tDCS Over the Contralesional Hemisphere on the Upper Limb Function in Stroke Patients
NCT05180929
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active treatment
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.
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
Sham comparator
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinical Centre of Serbia
OTHER
Military Medical Academy, Belgrade, Serbia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Tihomir Ilic
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tihomir V Ilic, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Military Medical Academy, Serbia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinic of Neurology, Military Medical Academy, Belgrade
Belgrade, , Serbia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MFVMA/12/13-15
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.