Stroke, IschemicNCT03839810
Stochastic Resonance Stimulation in Brain Plasticity and Post Stroke Motor Recovery
A study testing stochastic resonance electrical stimulation in people with Stroke, Ischemic and Healthy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
This study evaluates the effectiveness of stochastic resonance electric stimulation on neuromuscular control and proprioception in healthy and individuals with stroke. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Healthy
- What is being tested?
- stochastic resonance electrical stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2018to Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults without history of neurological disorders or limitation in range of motion for thumb flexion
- In the second stage
- first-ever cerebral cortical region involved chronic stroke, onset over a month
- able to perform active grasp on the affected side with the scores of manual muscle test at least two points
- at stable medical condition for intervention confirmed by a specialized physician.
- The exclusion criteria were
Show all 11Show fewer
- history of other neurological disorders
- cognitive impairment (Mini-Mental State Examination score < 24, MMSE)29
- unable to follow instructions
- contraindications of ES
- under 20 years old.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Yang-Ming University
Taipei, 112
Li-Wei Chou, PhD, +88628267092, lwchou@ym.edu.tw
Shiang-Lin Hou, +886988563887, g30622007@gm.ym.edu.tw
About this study
Official title: Effects of Stochastic Resonance Electrical Stimulation on Post Stroke Cortical Plasticity and Motor Function Recovery
This study evaluates the effectiveness of stochastic resonance electric stimulation on neuromuscular control and proprioception in healthy and individuals with stroke.
Read the detailed description
Stroke is one of the leading causes of motor disability. The main intervention strategy in stroke rehabilitation is to induce cortical plasticity for motor re-learning.
It has been demonstrated that electrical stimulation applied to the periphery can elicit abundant sensory afferent inputs to enhance excitability and activation area in the sensorimotor cortex. Recent evidence suggested that a new type of electrical stimulation pattern, stochastic resonance stimulation, is capable of efficiently enhancing the activation of peripheral and central nervous system. Therefore, the purpose of this study are to identify the effects of stochastic resonance electrical stimulation on neuromuscular control and proprioception, and to investigate the effectiveness of combining stochastic resonance electrical stimulation with rehabilitation program on post stroke motor function recovery.
- Conditions
- Stroke, Ischemic, Healthy
- Being tested
- stochastic resonance electrical stimulation
- Keywords
- stochastic resonance, proprioception, motor control, motor recovery
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stochastic resonance electrical stimulationOther
stochastic resonance electrical stimulation is applied in the upper extremity during motor functional training.
Sham comparator group uses sham stimulation - same electrode location, but no electrical current is applied during motor functional training
| Study group | Role | What they receive |
|---|---|---|
| stochastic resonance | Experimental | stochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function. Receives: Other: stochastic resonance electrical stimulation |
| sham stimulation | Sham comparator | sham electrical stimulation (same electrode location, but no electrical current is applied) is applied to the upper extremity during the subjects perform upper extremity motor function. Receives: Other: stochastic resonance electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG
we will calculate power spectral and see whether change in the alpha, beta, theta band
Measured: baseline and one minute after stimulation
Fugl-Meyer Assessment for Upper Extremity
changes in upper extremity function of the stroke subjects
Measured: baseline and one minute after stimulation
Secondary outcomes (3)
force deviation
we first calculated the absolute value of the difference between force output and the value of 50%MVC for each data point and then calculated the average force deviation value by dividing the sum of all values by the number of data points
Measured: baseline and one minute after stimulation
joint angle
ABS(the subject perform degree - target degree )
Measured: baseline and one minute after stimulation
muscle activation
EMG changes in stimulation
Measured: baseline and one minute after stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Sep 2018
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839810
- Sponsor's protocol ID
- MOST107-2314-B-010-050
- Status last verified
- Feb 2019
- First submitted
- 17 Jan 2019
- Last updated
- 15 Feb 2019
- 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 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stochastic Resonance Electrical Stimulation on Post Stroke Cortical Plasticity and Motor Function Recovery
- ClinicalTrials.gov ID
- NCT03839810
- Acronym / sponsor ID
- MOST107-2314-B-010-050
- Conditions
- Stroke, Ischemic, Healthy
- Keywords
- stochastic resonance, proprioception, motor control, motor recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Taipei Veterans General Hospital, Taiwan
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 15 Feb 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.
This study evaluates the effectiveness of stochastic resonance electric stimulation on neuromuscular control and proprioception in healthy and individuals with stroke.
Detailed description
Stroke is one of the leading causes of motor disability. The main intervention strategy in stroke rehabilitation is to induce cortical plasticity for motor re-learning.
It has been demonstrated that electrical stimulation applied to the periphery can elicit abundant sensory afferent inputs to enhance excitability and activation area in the sensorimotor cortex. Recent evidence suggested that a new type of electrical stimulation pattern, stochastic resonance stimulation, is capable of efficiently enhancing the activation of peripheral and central nervous system. Therefore, the purpose of this study are to identify the effects of stochastic resonance electrical stimulation on neuromuscular control and proprioception, and to investigate the effectiveness of combining stochastic resonance electrical stimulation with rehabilitation program on post stroke motor function recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stochastic resonance | Experimental | Other: stochastic resonance electrical stimulationstochastic resonance electrical stimulation is applied to the upper extremity during the subjects perform upper extremity motor function. |
| sham stimulation | Sham comparator | Other: stochastic resonance electrical stimulationsham electrical stimulation (same electrode location, but no electrical current is applied) is applied to the upper extremity during the subjects perform upper extremity motor function. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- healthy adults without history of neurological disorders or limitation in range of motion for thumb flexion
- In the second stage
- first-ever cerebral cortical region involved chronic stroke, onset over a month
- able to perform active grasp on the affected side with the scores of manual muscle test at least two points
- at stable medical condition for intervention confirmed by a specialized physician.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| stochastic resonance electrical stimulationstochastic resonance electrical stimulation is applied in the upper extremity during motor functional training. Sham comparator group uses sham stimulation - same electrode location, but no electrical current is applied during motor functional training | Other | sham stimulation, stochastic resonance |
Primary outcome
EEG
Time frame: baseline and one minute after stimulation
we will calculate power spectral and see whether change in the alpha, beta, theta band
Fugl-Meyer Assessment for Upper Extremity
Time frame: baseline and one minute after stimulation
changes in upper extremity function of the stroke subjects
3 secondary outcomes
force deviation
Time frame: baseline and one minute after stimulation
joint angle
Time frame: baseline and one minute after stimulation
muscle activation
Time frame: baseline and one minute after stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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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.
Li-Wei Chou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stochastic resonance electrical stimulation in people with Stroke, Ischemic and Healthy, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 11 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Wei Chou, PhD (+886228267092, lwchou@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG (time frame: baseline and one minute after stimulation). 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 15 Feb 2019.