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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04059848
Enrollment
30
Registered
2019-08-16
Start date
2017-01-13
Completion date
2019-07-31
Last updated
2019-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke

Keywords

Transcranial direct current stimulation, Neuromuscular electrical stimulation, Stroke, Rehabilitation

Brief 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.

Detailed 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.

Interventions

COMBINATION_PRODUCTtDCS(Intelect Mobile Stimulation and Combination, DJO, France)
COMBINATION_PRODUCTNMES(Enraf Nonius, Endomed-182, Netherlands)

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
upper extremity subscale of Fugl-Meyer assessmentat beginning of the intervention, after 3-week of treatment, and one-month follow-upThe 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.
Action Research Arm Testat beginning of the intervention, after 3-week of treatment, and one-month follow-upThe 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026