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

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Combination of tDCS and NMES

Combination of tDCS and sham NMES

Combination of sham tDCS and sham NMES

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Transcranial direct current stimulation, Neuromuscular electrical stimulation, upper extremity motor recovery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria(healthy subjects):

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

Exclusion Criteria(healthy subjects):

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
The patients is suitable for the experiment by investigator assessedInclusion

Inclusion Criteria(stroke):

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
Muscle tone at the wrist flexor with a modified Ashworth scale≦2

Exclusion Criteria(stoke):

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

Sites / Locations

Kaohsiung Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Combination of tDCS and NMES

Combination of tDCS and sham NMES

Combination of sham tDCS and sham NMES

Arm Description

Both tDCS and NMES conduct simultaneously for 30 minutes.

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.

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.

Outcomes

Primary Outcome Measures

Movement performance assessment

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

Secondary Outcome Measures

Mapping of brain cortex

This examination is optional use equipment of brain mapping (single pulse transcranial magnetic stimulation) and operated under trained staff, the attending is consulted. This examination can be stopped at any time if participants do not want to perform or feeling unwell.

Full Information

NCT ID

NCT02821884

First Posted

June 27, 2016

Last Updated

August 14, 2019

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02821884

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

January 13, 2017 (Actual)

Primary Completion Date

July 30, 2019 (Actual)

Study Completion Date

July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Combination of tDCS and NMES

Arm Type

Experimental

Arm Description

Both tDCS and NMES conduct simultaneously for 30 minutes.

Arm Title

Combination of tDCS and sham NMES

Arm Type

Active Comparator

Arm Description

Arm Title

Combination of sham tDCS and sham NMES

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Combination of tDCS and NMES

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Combination of tDCS and sham NMES

Intervention Description

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).

Intervention Type

Device

Intervention Name(s)

Combination of sham tDCS and sham NMES

Intervention Description

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).

Primary Outcome Measure Information:

Title

Movement performance assessment

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Mapping of brain cortex

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria(healthy subjects): Age: 20~65 years old Who are willing to participate in the experiment Signed the consent Right handed Exclusion Criteria(healthy subjects): 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 The patients is suitable for the experiment by investigator assessedInclusion Inclusion Criteria(stroke): 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 Muscle tone at the wrist flexor with a modified Ashworth scale≦2 Exclusion Criteria(stoke): Speech disorder or global aphasia Musculoskeletal pathology or neurological disorders affecting movements in the paretic upper limbs Epilepsy or family history Cardiac pacemaker Metallic implant in the head Pregnancy Diabetic, peripheral vascular disease or neuropathy that attributable to sensory complete injury Have intracranial space occupied lesion, ex: brain tumors, arteriovenous malformations Had brain surgery Meningitis and encephalitis Expected to conduct brain surgery and major surgery during the experiment The patients is suitable for the experiment by investigator assessed

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jau-Hong Lin, Professor

Organizational Affiliation

Kaohsiung Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kaohsiung Medical University

City

Kaohsiung

ZIP/Postal Code

807

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

33901041

Citation

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.

Results Reference

derived

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

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