Combine Transcranial Direct Current Stimulation and Neuromuscular Electrical Stimulation on Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Transcranial direct current stimulation (tDCS) has been shown not only to improve motor
      function but also increase cortical excitability and neural plasticity. Several studies
      demonstrated that the combination of tDCS and different treatments are more effective than a
      single tDCS alone. However, the effects of combination tDCS and neuromuscular electrical
      stimulation (NMES) on upper extremity motor recovery in patients with stroke have not yet
      been investigated. Taking into consideration the safety and feasibility of new medical
      technology, recruitment of healthy subjects as a pilot study. And then recruit the stroke
      patients to investigate the effects for the combination of tDCS and NMES on upper extremity
      motor recovery in stroke.
    

Detailed description: 
      The Transcranial direct current stimulation (tDCS) and neuromuscular electrical stimulation
      (NMES) is non-invasive electrical stimulation, and some studies have proved efficacy of the
      tDCS and NMES on healthy subjects and stroke patients. However, the effects of combination
      tDCS and NMES on upper extremity motor recovery and neural plasticity in healthy subjects and
      patients with stroke have not yet been investigated. Moreover in order to discover the tDCS
      combine NMES of the safety and feasibility and influences on neural plasticity and motor
      function, the cortical excitability and functional recovery measurements (clinical scales)
      are taken in the healthy subjects and stroke.

      The right-handed subjects will be received the combination of tDCS and NMES for 30 minutes.
      The changes in the hand function and cortical excitability were probed by recording movement
      performance scales in upper extremity and mapping of brain cortex before and after the
      intervention.

      The patients will be assigned into one of three groups (A, B,C) by block randomization. All
      participants will receive regular traditional rehabilitation. In addition, three groups will
      receive an additional 3 weeks, 5 times per week, 30 minutes once daily, total 15 session.
      Group A: both tDCS and NMES conduct simultaneously for 30 minutes. Group B: combination of
      tDCS and sham NMES Group C: combination of sham tDCS and sham NMES.
    

Intervention name(s): Combination of tDCS and NMES; Combination of tDCS and sham NMES; Combination of sham tDCS and sham NMES
Intervention type(s): Device; Device; Device
Intervention description(s): Both tDCS and NMES conduct simultaneously for 30 minutes. The anodal electrode of tDCS is placed on the scalp site corresponding to primary motor cortex (M1) of the hemisphere affected by stroke. The cathodal electrode of tDCS is placed on the scalp site corresponding to unaffected primary motor cortex. The current is initially increased in a ramp-like fashion over 30 seconds until reaching 2 mA and is decreased ramp-like fashion over 30 seconds until reaching 0 mA. The NMES electrodes are placed over the following muscle: extensor digitorum communis, extensor carpi radialis to produce wrist and hand extension. The settings for the NMES is frequency at 50 Hz, pulse width of 200μs,duty cycle of 10 seconds on and 10 seconds off,current amplitude is adjusted to patients comfort (10-20mA).; Both tDCS and sham NMES conduct simultaneously for 30 minutes. The anodal electrode of tDCS is placed on the scalp site corresponding to primary motor cortex (M1) of the hemisphere affected by stroke. The cathodal electrode of tDCS is placed on the scalp site corresponding to unaffected primary motor cortex. The current is initially increased in a ramp-like fashion over 30 seconds until reaching 2 mA and is decreased ramp-like fashion over 30 seconds until reaching 0 mA. Sham NMES electrodes are placed away from all extensor digitorum communis, extensor carpi radialis motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation(wrist extension).; Both sham tDCS and sham NMES conduct simultaneously for 30 minutes. Sham tDCS electrodes are placed in the same position on patients receiving the sham stimulation. Just like during real tDCS, stimulation is started in a ramp-like fashion but fade out slowly after 30 seconds. Sham NMES electrodes are placed away from all extensor digitorum communis, extensor carpi radialis motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation(wrist extension).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Transcranial direct current stimulation; Neuromuscular electrical stimulation; upper extremity motor recovery