StrokeNCT03277534
Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke
A study testing Electrical stimulation in people with Stroke, run by National Yang Ming Chiao Tung University.
Trial summary
This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2013to 4 Jan 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first-ever cerebral cortical region involved chronic stroke, onset over a month,
- able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and
- at stable medical condition for intervention
Who cannot join
- history of other neurological disorders,
- cognitive impairment (Mini-Mental State Examination score <24, MMSE),26
- unable to follow orders,
- contraindications of ES, and
- under 20 years old
About this study
Official title: Effects of 8-week Sensory Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke
This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).
Read the detailed description
Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.
- Conditions
- Stroke
- Being tested
- Electrical stimulation, Sham electrical stimulation
- Keywords
- electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulationOther
sensory electrical stimulation was applied prior to upper limb functional training
Sham electrical stimulationOther
electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied
| Study group | Role | What they receive |
|---|---|---|
| Electrical stimulation | Experimental | Not described Receives: Other: Electrical stimulation |
| Control | Sham comparator | Not described Receives: Other: Sham electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment for Upper Extremity
evaluate changes in upper extremity function of the stroke subjects
Measured: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
EEG-EMG coherence
evaluate changes in functional connectivity between motor cortex and active muscles
Measured: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start28 Aug 2013
- Primary completion4 Jan 2017
- Study completion4 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Wei Chou, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277534
- Sponsor's protocol ID
- 104-2314-B-010-024
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 8-week Sensory Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke
- ClinicalTrials.gov ID
- NCT03277534
- Acronym / sponsor ID
- 104-2314-B-010-024
- Conditions
- Stroke
- Keywords
- electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 28 Aug 2013 (actual)
- Primary completion
- 4 Jan 2017 (actual)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 11 Sep 2017 (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.
This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).
Detailed description
Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electrical stimulation | Experimental | Other: Electrical stimulation |
| Control | Sham comparator | Other: Sham electrical stimulation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- first-ever cerebral cortical region involved chronic stroke, onset over a month,
- able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and
- at stable medical condition for intervention
Key exclusion criteria (5 listed)
- history of other neurological disorders,
- cognitive impairment (Mini-Mental State Examination score <24, MMSE),26
- unable to follow orders,
- contraindications of ES, and
- under 20 years old
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 |
|---|---|---|
| Electrical stimulationsensory electrical stimulation was applied prior to upper limb functional training | Other | Electrical stimulation |
| Sham electrical stimulationelectrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied | Other | Control |
Primary outcome
Fugl-Meyer Assessment for Upper Extremity
Time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
evaluate changes in upper extremity function of the stroke subjects
EEG-EMG coherence
Time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended
evaluate changes in functional connectivity between motor cortex and active muscles
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 11 Sep 2017.
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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 Electrical stimulation in people with Stroke, run by National Yang Ming Chiao Tung University.
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 3 inclusion and 5 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 11 Sep 2017. 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?
Fugl-Meyer Assessment for Upper Extremity (time frame: before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended). 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 11 Sep 2017.