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

NCT02821884 | Completed

• 1 other identifier: KMUHIRB-F(I)-20150053
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Transcranial direct current stimulation; Neuromuscular electrical stimulation; upper extremity motor recovery

Outcome Measures

Primary Outcomes (1)

• Movement performance assessment

  Movement performance assessment by clinical motor assessment scales in upper extremity executed by qualified physiotherapy in 3 groups.

  Change from baseline motor performance at 3 weeks, 1 month and 6 months.

Secondary Outcomes (1)

• Mapping of brain cortex

  Change from baseline motor performance at 3 weeks, 1 month and 6 months.

Study Arms (3)

Combination of tDCS and NMES

EXPERIMENTAL

Both tDCS and NMES conduct simultaneously for 30 minutes.

Device: Combination of tDCS and NMES

Combination of tDCS and sham NMES

ACTIVE COMPARATOR

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.

Device: Combination of tDCS and sham NMES

Combination of sham tDCS and sham NMES

SHAM COMPARATOR

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.

Device: Combination of sham tDCS and sham NMES

Interventions

Combination of tDCS and NMES DEVICE

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).

Combination of tDCS and NMES

Combination of tDCS and sham NMES DEVICE

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).

Combination of tDCS and sham NMES

Combination of sham tDCS and sham NMES DEVICE

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).

Combination of sham tDCS and sham NMES

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 20\~65 years old
• Who are willing to participate in the experiment
• Signed the consent
• Right handed

You may not qualify if:

• Musculoskeletal pathology or neurological disorders affecting movements in the upper limbs
• Epilepsy or family history
• Cardiac pacemaker
• Metallic implant in the head
• Pregnancy
• Sensory complete injury in upper limb
• Had brain surgery
• Expected to conduct brain surgery and major surgery during the experiment
• Signed the informed consent
• First-ever ischemic stroke
• Stroke at least 6 months
• Unilateral hemiplegia
• No severe cognitive impairment (National Institutes of Health Stroke Scale-Level of Consciousness: 0, Level of Consciousness Questions: 0, Level of Consciousness Commands: 0)
• Sit on a chair for more than 30 minutes independently
• Brunnstrom recovery stage≧3 in the paretic hand

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

• Wei YY, Koh CL, Hsu MJ, Lo SK, Chen CH, Lin JH. Effects of Transcranial Direct Current Stimulation Combined With Neuromuscular Electrical Stimulation on Upper Extremity Motor Function in Patients With Stroke. Am J Phys Med Rehabil. 2022 Feb 1;101(2):145-151. doi: 10.1097/PHM.0000000000001759.

  PMID: 33901041 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jau-Hong Lin, Professor

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Department of Physical Therapy, Kaohsiung Medical University, Taiwan

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 4, 2016
• Study Start: January 13, 2017
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)