Chronic StrokeNCT04059848
Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke
A study testing tDCS(Intelect Mobile Stimulation and Combination, DJO, France) and NMES(Enraf Nonius, Endomed-182, Netherlands) in people with Chronic Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- tDCS(Intelect Mobile Stimulation and Combination, DJO, France) and NMES(Enraf Nonius, Endomed-182, Netherlands)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First onset
- Ischemic stroke
- Stroke onset > 6 months
- Brunnstrom recovery stage: ≧3
- Modified Ashworth Scale Elbow flexor : ≦3
Who cannot join
- Severe language or cognitive impairment
- Orthopaedic or neurological problems
- Pregnancy
- Contraindications for tDCS or NMES
About this study
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.
Read the 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.
- Conditions
- Chronic Stroke
- Being tested
- tDCS(Intelect Mobile Stimulation and Combination, DJO, France), NMES(Enraf Nonius, Endomed-182, Netherlands)
- Keywords
- Transcranial direct current stimulation, Neuromuscular electrical stimulation, Stroke, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS(Intelect Mobile Stimulation and Combination, DJO, France)Combination product
NMES(Enraf Nonius, Endomed-182, Netherlands)Combination product
| Study group | Role | What they receive |
|---|---|---|
| tDCS combined with NMES | Experimental | In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). Receives: Combination Product: tDCS(Intelect Mobile Stimulation and Combination, DJO, France); Combination Product: NMES(Enraf Nonius, Endomed-182, Netherlands) |
| tDCS combined with sham NMES | Active comparator | In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). Receives: Combination Product: tDCS(Intelect Mobile Stimulation and Combination, DJO, France); Combination Product: NMES(Enraf Nonius, Endomed-182, Netherlands) |
| sham tDCS combined with sham NMES | Sham comparator | In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). Receives: Combination Product: tDCS(Intelect Mobile Stimulation and Combination, DJO, France); Combination Product: NMES(Enraf Nonius, Endomed-182, Netherlands) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at beginning of the intervention, after 3-week of treatment, and one-month follow-up
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.
Measured: at beginning of the intervention, after 3-week of treatment, and one-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start13 Jan 2017
- Primary completion30 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059848
- Sponsor's protocol ID
- KMUHIRB F(I)-20150053
- Status last verified
- Aug 2019
- First submitted
- 14 Aug 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke
- ClinicalTrials.gov ID
- NCT04059848
- Acronym / sponsor ID
- KMUHIRB F(I)-20150053
- Conditions
- Chronic Stroke
- Keywords
- Transcranial direct current stimulation, Neuromuscular electrical stimulation, Stroke, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS combined with NMES | Experimental | Combination Product: tDCS(Intelect Mobile Stimulation and Combination, DJO, France), Combination Product: NMES(Enraf Nonius, Endomed-182, Netherlands)In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). |
| tDCS combined with sham NMES | Active comparator | Combination Product: tDCS(Intelect Mobile Stimulation and Combination, DJO, France), Combination Product: NMES(Enraf Nonius, Endomed-182, Netherlands)In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). |
| sham tDCS combined with sham NMES | Sham comparator | Combination Product: tDCS(Intelect Mobile Stimulation and Combination, DJO, France), Combination Product: NMES(Enraf Nonius, Endomed-182, Netherlands)In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First onset
- Ischemic stroke
- Stroke onset > 6 months
- Brunnstrom recovery stage: ≧3
- Modified Ashworth Scale Elbow flexor : ≦3
Key exclusion criteria (4 listed)
- Severe language or cognitive impairment
- Orthopaedic or neurological problems
- Pregnancy
- Contraindications for tDCS or NMES
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCS(Intelect Mobile Stimulation and Combination, DJO, France) | Combination product | sham tDCS combined with sham NMES, tDCS combined with NMES, tDCS combined with sham NMES |
| NMES(Enraf Nonius, Endomed-182, Netherlands) | Combination product | sham tDCS combined with sham NMES, tDCS combined with NMES, tDCS combined with sham NMES |
Primary outcome
upper extremity subscale of Fugl-Meyer assessment
Time frame: at beginning of the intervention, after 3-week of treatment, and one-month follow-up
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.
Action Research Arm Test
Time frame: at beginning of the intervention, after 3-week of treatment, and one-month follow-up
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS(Intelect Mobile Stimulation and Combination, DJO, France) and NMES(Enraf Nonius, Endomed-182, Netherlands) in people with Chronic Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper extremity subscale of Fugl-Meyer assessment (time frame: at beginning of the intervention, after 3-week of treatment, and one-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2019.