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NCT Number: NCT02542982

tDCS and Motor Training and Motor Deficit After Stroke

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinic of Neurology, Military Medical Academy, Belgrade

Belgrade, 11000, Serbia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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 outcomes

  1. Jebsen Taylor Test of Hand Function

    Time frame: one day, two weeks and one month

    changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately

Secondary outcomes

  1. hand grip force

    Time frame: two weeks and one month

    changes of baseline maximum grip force of the hand measured by whole-hand dynamometer

  2. upper limb Fugl-Meyer assessment of Motor Recovery after Stroke

    Time frame: one day, two weeks and one month

    changes of initial score from domain of motor functions for upper limb

Sponsors and collaborators

Lead sponsor

Military Medical Academy, Belgrade, Serbia

Other

Collaborators

  • Clinical Centre of Serbia

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2015
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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