StrokeNCT04576013
Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
A study testing Peripheral nerve stimulation (PNS) and Intensive upper extremity motor training in people with Stroke, run by University of Kentucky at 1 site in United States.
Trial summary
Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Peripheral nerve stimulation (PNS) and Intensive upper extremity motor training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2016to 22 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have severe upper extremity motor deficit after a single stroke
- Stroke onset at least 12 months ago
Who cannot join
- Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
- Untreated depression
- History of multiple strokes
- History of seizure
- History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
Show all 9Show fewer
- Presence of ferromagnetic material in the cranium except in the mouth, including metal fragments from occupational exposure, and surgical clips in or near the brain
- Cardiac or neural pacemakers or implanted medication pumps
- Receptive aphasia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky at Cardinal Hill Rehabilitation Hospital
Lexington, Kentucky, 40504
About this study
Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.
Read the detailed description
This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.
- Conditions
- Stroke
- Being tested
- Peripheral nerve stimulation (PNS), Intensive upper extremity motor training
- Keywords
- neuroplasticity, rehabilitation, peripheral nerve stimulation, motor training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve stimulation (PNS)Device
Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
Intensive upper extremity motor trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Active PNS during training | Experimental | Individuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm. Receives: Device: Peripheral nerve stimulation (PNS); Behavioral: Intensive upper extremity motor training |
| Active PNS before training | Active comparator | Individuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm. Receives: Device: Peripheral nerve stimulation (PNS); Behavioral: Intensive upper extremity motor training |
| Sham PNS during training | Sham comparator | Individuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm. Receives: Device: Peripheral nerve stimulation (PNS); Behavioral: Intensive upper extremity motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment
This is a quantitative measure of motor recovery, coordination, and speed.
Measured: Baseline, Immediately post-intervention
Secondary outcomes (3)
Action Research Arm Test
This test measures changes in the upper extremity and consists of four specific tests to measure grasp, grip, pinch, and gross movement.
Measured: Baseline, Immediately post-intervention
Stroke Impact Scale
This is a self-report that assesses strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, and participation.
Measured: Baseline, Immediately post-intervention
Cortical motor map volume
This is performed using non-invasive transcranial magnetic stimulation to determine which parts of the brain control a muscle in the arm or hand.
Measured: Baseline, Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study start23 Feb 2016
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Why it stopped: PI is leaving the university.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lumy Sawaki, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576013
- Sponsor's protocol ID
- 44185
- Status last verified
- Feb 2021
- First submitted
- 29 Sep 2020
- Last updated
- 25 Feb 2021
- 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 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Stimulation to Improve Upper Extremity Function After Severe Stroke
- ClinicalTrials.gov ID
- NCT04576013
- Acronym / sponsor ID
- 44185
- Conditions
- Stroke
- Keywords
- neuroplasticity, rehabilitation, peripheral nerve stimulation, motor training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is leaving the university.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- 23 Feb 2016 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 5 Oct 2020 (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.
Subjects will receive non-invasive stimulation of nerves on their arm and intensive motor training of their arm. The timing of the stimulation in relation to the training will vary by group.
Detailed description
This study will look at the differences in improvement of hand and arm function when nerve stimulation is applied at different times in relation to motor training. The nerve stimulation, called peripheral nerve stimulation (PNS), is non-invasive and painless. Subjects in the study may receive strong or mild PNS. Subjects will also vary by whether PNS is delivered for 2 hours before the 2 hours of motor training, or during the 2 hours of motor training. Which level of stimulation and its timing will be determined randomly for each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active PNS during training | Experimental | Device: Peripheral nerve stimulation (PNS), Behavioral: Intensive upper extremity motor trainingIndividuals in this group will receive active PNS while participating in 2 hours of motor training of the affected arm. |
| Active PNS before training | Active comparator | Device: Peripheral nerve stimulation (PNS), Behavioral: Intensive upper extremity motor trainingIndividuals in this group will receive 2 hours of active PNS before participating in 2 hours of motor training of the affected arm. |
| Sham PNS during training | Sham comparator | Device: Peripheral nerve stimulation (PNS), Behavioral: Intensive upper extremity motor trainingIndividuals in this group will receive 2 hours of sham PNS while participating in 2 hours of motor training of the affected arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have severe upper extremity motor deficit after a single stroke
- Stroke onset at least 12 months ago
Key exclusion criteria (9 listed)
- Addition or change in the dosage of drugs known to exert detrimental effects on motor recovery within 3 months of enrollment
- Untreated depression
- History of multiple strokes
- History of seizure
- History of head injury with loss of consciousness, severe alcohol or drug abuse, or psychiatric illness
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 |
|---|---|---|
| Peripheral nerve stimulation (PNS)Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable. | Device | Active PNS before training, Active PNS during training, Sham PNS during training |
| Intensive upper extremity motor training | Behavioural | Active PNS before training, Active PNS during training, Sham PNS during training |
Primary outcome
Fugl-Meyer Assessment
Time frame: Baseline, Immediately post-intervention
This is a quantitative measure of motor recovery, coordination, and speed.
3 secondary outcomes
Action Research Arm Test
Time frame: Baseline, Immediately post-intervention
Stroke Impact Scale
Time frame: Baseline, Immediately post-intervention
Cortical motor map volume
Time frame: Baseline, Immediately post-intervention
Results and safety
The study was stopped early (reason given: PI is leaving the university.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral nerve stimulation (PNS) and Intensive upper extremity motor training in people with Stroke, run by University of Kentucky at 1 site in United States.
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 2 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Feb 2021. 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 United States. 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?
The study was stopped early (reason given: PI is leaving the university.). Results are not available in the source record.
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 (time frame: Baseline, Immediately post-intervention). 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 25 Feb 2021.