Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke

Chronic Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04059848
• Other study ID #: KMUHIRB F(I)-20150053
• Status: Completed
• Phase: N/A
• Start date: January 13, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: August 2019
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to investigate the effects of the combination treatment strategy. A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset > 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

Description:

Background and objectives: Previous studies have shown that transcranial direct current stimulation (tDCS) and Neuromuscular electrical stimulation (NMES) could be effective for promoting motor recovery of stroke patients. However, the effects of tDCS combined with NMES on upper extremity (UE) motor recovery in patients with stroke have not been investigated. The purpose of this study was to investigate the effects of the combination treatment strategy. Methods: A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset > 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. Results: Most of the participants had mild to moderate disability in activity of daily living. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. Conclusion: This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• First onset

• Ischemic stroke

• Stroke onset > 6 months

• Brunnstrom recovery stage: ?3

• Modified Ashworth Scale Elbow flexor : ?3

Exclusion Criteria:

• Severe language or cognitive impairment

• Orthopaedic or neurological problems

• Pregnancy

• Contraindications for tDCS or NMES

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Combination Product:
• tDCS(Intelect Mobile Stimulation and Combination, DJO, France)

• NMES(Enraf Nonius, Endomed-182, Netherlands)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	upper extremity subscale of Fugl-Meyer assessment	The Fugl-Meyer assessment consists of the 33-item upper-extremity (UE-FM) and 17-item lower-extremity subscales.(Fugl-Meyer et al., 1975) The items of the FM are mainly scored on a 3-point scale, from 0 to 2. The total score of the UE-FM ranges from 0 to 66.	at beginning of the intervention, after 3-week of treatment, and one-month follow-up
Primary	Action Research Arm Test	The ARAT(Lyle, 1981) has 19 items in four categories: grasp, grip, pinch, and gross movement. Each item is graded on a 4-point scale, from 0 to 3. The total score has a range of 0 to 57.	at beginning of the intervention, after 3-week of treatment, and one-month follow-up