Effects of Bihemispheric Transcranial Direct Current Stimulation on Motor Function in Stroke Patients
Condition: Stroke; Upper Extremity Paresis; Transcranial Direct Current Stimulation
MeSH terms: Stroke; Paresis
Study type: Interventional

Summary: 
      Motor impairment (impairment of movement) due to stroke is one of the leading disabilities in
      adults. In addition to established means of facilitating motor recovery after stroke such as
      physical and occupational therapy, a variety of experimental rehabilitation approaches have
      been tested. Although there have been significant advances in stroke rehabilitation with
      these techniques and treatments, research on this subject is continuing. Recent studies have
      focused on non-invasive brain stimulation techniques. Transcranial magnetic stimulation (TMS)
      or transcranial direct current stimulation (tDCS) therapies, which are methods of
      non-invasive brain stimulation that may be effective on cerebral remodelling, aim to
      reestablish the disturbed balance between the anatomic areas of the brain seen in stroke
      patients.

      The primary aim of this study is to evaluate the effectiveness of bihemispheric transcranial
      direct current stimulation (tDCS) applications on the upper extremity motor functions of
      patients with stroke.
    

Detailed description: 
      Motor impairment due to ischemic and hemorrhagic stroke is one of the leading disabilities in
      adults. In addition to established means of facilitating motor recovery after stroke such as
      physical and occupational therapy, a variety of experimental rehabilitation approaches have
      been tested. Recent developments include noninvasive brain stimulation techniques such as
      repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current
      stimulation (tDCS). The use of these tools is based on neurophysiologic studies demonstrating
      an imbalance of interhemispheric interactions which appears to interfere with the recovery
      process.

      The model of interhemispheric imbalance provides a framework for developing hypotheses based
      on its 2 facets: 1) upregulating excitability of intact portions of the ipsilesional motor
      cortex and 2) downregulating excitability of the contralesional motor cortex to modulate its
      unrestrained inhibitory influence on ipsilesional regions. Studies to date have shown have
      shown the beneficial effects of tDCS on motor skills and motor learning.

      Bihemispheric tDCS may potentiate the effects of anodal stimulation to the lesional
      hemisphere through additional modulation of interhemispheric interactions via cathodal
      stimulation to the contralesional motor cortex.

      The primary aim of this prospective, randomized, sham controlled study is to evaluate the
      effectiveness of bihemispheric transcranial direct current stimulation (tDCS) applications on
      the upper extremity motor functions of patients with stroke.
    

Intervention name(s): tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): A constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system).; For sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation
Other intervention name(s): Conventional physiotherapy and occupational therapy; Conventional physiotherapy and occupational therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The aim of the study is to evaluate and compare the effect of tDCS plus conventional physiotherapy and occupational therapy to sham tDCS plus conventional physiotherapy and occupational therapy on upper extremity motor function in patients with subacute stroke was aimed in our study.
32 patients will be randomly assigned to one of two groups in parallel for the duration of the study: bihemispheric tDCS (n:16), or sham tDCS (n:16). In addition to a conventional physiotherapy and occupational therapy program, bihemispheric tDCS application will be applied to one group and sham tDCS applied to the second group. A constant current stimulator(ZMI Electronics Limited,Taiwan,2012) will be used for the application of tDCS. In both groups, the tDCS application will be started simultaneously with the occupational therapy session and will last for thirty minutes.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cortical stimulation; Motor function; Rehabilitation; Stroke