Combine Transcranial Direct Current Stimulation and Neuromuscular Electrical Stimulation on Stroke Patients

Kaohsiung Medical University

Status: Completed

Conditions: Stroke

Treatments: Device: Combination of sham tDCS and sham NMES; Device: Combination of tDCS and NMES; Device: Combination of tDCS and sham NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT02821884

KMUHIRB-F(I)-20150053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria(healthy subjects):

1. Age: 20~65 years old
2. Who are willing to participate in the experiment
3. Signed the consent
4. Right handed

Exclusion Criteria(healthy subjects):

1. Musculoskeletal pathology or neurological disorders affecting movements in the upper limbs
2. Epilepsy or family history
3. Cardiac pacemaker
4. Metallic implant in the head
5. Pregnancy
6. Sensory complete injury in upper limb
7. Had brain surgery
8. Expected to conduct brain surgery and major surgery during the experiment
9. The patients is suitable for the experiment by investigator assessedInclusion

Inclusion Criteria(stroke):

1. Signed the informed consent
2. First-ever ischemic stroke
3. Stroke at least 6 months
4. Unilateral hemiplegia
5. No severe cognitive impairment (National Institutes of Health Stroke Scale-Level of Consciousness: 0, Level of Consciousness Questions: 0, Level of Consciousness Commands: 0)
6. Sit on a chair for more than 30 minutes independently
7. Brunnstrom recovery stage≧3 in the paretic hand
8. Muscle tone at the wrist flexor with a modified Ashworth scale≦2

Exclusion Criteria(stoke):

1. Speech disorder or global aphasia
2. Musculoskeletal pathology or neurological disorders affecting movements in the paretic upper limbs
3. Epilepsy or family history
4. Cardiac pacemaker
5. Metallic implant in the head
6. Pregnancy
7. Diabetic, peripheral vascular disease or neuropathy that attributable to sensory complete injury
8. Have intracranial space occupied lesion, ex: brain tumors, arteriovenous malformations
9. Had brain surgery
10. Meningitis and encephalitis
11. Expected to conduct brain surgery and major surgery during the experiment
12. The patients is suitable for the experiment by investigator assessed

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

Combination of tDCS and NMES

Experimental group

Description:

Both tDCS and NMES conduct simultaneously for 30 minutes.

Treatment:

Device: Combination of tDCS and NMES

Combination of tDCS and sham NMES

Active Comparator group

Description:

Both tDCS and sham NMES conduct simultaneously for 30 minutes. Sham NMES electrodes are placed away from all motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation.

Treatment:

Device: Combination of tDCS and sham NMES

Combination of sham tDCS and sham NMES

Sham Comparator group

Description:

Both sham tDCS and sham NMES conduct simultaneously for 30 minutes. Shame tDCS is started in a ramp-like fashion but fade out slowly after 30 seconds. Sham NMES electrodes are placed away from all motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation.

Treatment:

Device: Combination of sham tDCS and sham NMES