StrokePhase 1/2NCT02587234
Driving Neuroplasticity With Nerve Stimulation and Modified CIT
A Phase 1/2 study testing peripheral nerve stimulation in people with Stroke and Cerebrovascular Accident, run by University of Kentucky.
Trial summary
The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- peripheral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Apr 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke patients
- Single stroke
- Chronic (more than 12 months after from stroke)
- At least 21 years old, but there is no upper age range for this project.
- Participants must be able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Who cannot join
- History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
- History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
- Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- Cognitive deficit severe enough to preclude informed consent
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
- Participants with history of untreated depression.
About this study
Official title: Driving Neuroplasticity With Nerve Stimulation and Modified Constraint-Induced Therapy
The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).
Read the detailed description
Stroke is one the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. A major goal of the research in stroke rehabilitation is to harness the capacity of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training. A new emerging approach called constraint-induced therapy (CIT) is an intensive functional motor training and has produced promising results in the field of stroke rehabilitation. CIT involves restraining the unaffected arm with a sling or glove combined with intense task-oriented therapy of the affected side for six hours daily during 2 weeks. This pilot study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training to improve hand motor function. While the functional motor training follows identical principles of CIT, the length of daily training will be shortened to 4 hours daily and thus the investigators will refer in this proposal as a modified CIT. Preliminary data for this study demonstrated that peripheral nerve stimulation results in increased cortical motor excitability in normal subjects. In addition, learning and use-dependent plasticity can be substantially enhanced by a single session of 2 hours of peripheral nerve stimulation in chronic stroke patients. The goal of this study is to test the hypothesis that stroke patients treated with upper extremity peripheral nerve stimulation preceding CIT (intervention group) will have improved hand motor function compared to a group receiving lower extremity peripheral nerve stimulation and CIT (control group).
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- peripheral nerve stimulation
- Keywords
- motor recovery, chronic, human, sensory, afferent input, motor training
- Medical subject headings
- Stroke, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve stimulationDevice
Non-invasive stimulation of median, ulnar and radial nerves
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training Receives: Device: peripheral nerve stimulation |
| Sham PNS | Sham comparator | 2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training Receives: Device: peripheral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wolf Motor Function Test (WMFT), Timed Portion
Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline
Measured: baseline, post-intervention, 1-month follow-up
Secondary outcomes (2)
Change in Fugl Meyer Assessment Motor Score
Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline. The scores can range from 0 to 66, with higher scores indicating better performance. The scores are calculated by summing the scores to the 33 individual tasks.
Measured: baseline, post-intervention, 1-month follow-up
Change in Action Research Arm Test (ARAT)
Values given are score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline.
The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement).
Performance on each item is rated on a 4-point ordinal scale ranging from:
3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty
1: Performs test partially 0: Can perform no part of test The maximum score on the ARTS is 57 points (possible range 0 to 57).
Measured: baseline, post-intervention, 1-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 posted27 Oct 2015 (estimated)
- Study startNov 2006
- Primary completionFeb 2010
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 21 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
- NCT02587234
- Sponsor's protocol ID
- R03HD049408
- Status last verified
- Sep 2023
- First submitted
- 23 Oct 2015
- Last updated
- 13 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Carrico C, Chelette KC 2nd, Westgate PM, Salmon-Powell E, Nichols L, Sawaki L. Randomized Trial of Peripheral Nerve Stimulation to Enhance Modified Constraint-Induced Therapy After Stroke. Am J Phys Med Rehabil. 2016 Jun;95(6):397-406. doi: 10.1097/PHM.0000000000000476.
PubMed 26945226
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Neuroplasticity With Nerve Stimulation and Modified Constraint-Induced Therapy
- ClinicalTrials.gov ID
- NCT02587234
- Acronym / sponsor ID
- R03HD049408
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- motor recovery, chronic, human, sensory, afferent input, motor training
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 14 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators proposed to evaluate the effectiveness of sustained peripheral nerve stimulation (PNS) to enhance the therapeutic effects of a modified form CIT (mCIT).
Detailed description
Stroke is one the most devastating and prevalent diseases, but efforts to limit the amount of tissue damaged in the acute phase have been disappointing, highlighting the need for effective therapeutic interventions after neurologic damage has occurred. A major goal of the research in stroke rehabilitation is to harness the capacity of the brain to reorganize after neurologic damage has occurred and thus ultimately lead to successful recovery of function. Data from animal and human models have suggested that sensory input plays an important role in motor output, possibly by influencing cortical plasticity. However, in spite of the advances to date, little is known about the extent to which sensory input in the form of peripheral nerve stimulation can be successfully combined to physical training. A new emerging approach called constraint-induced therapy (CIT) is an intensive functional motor training and has produced promising results in the field of stroke rehabilitation. CIT involves restraining the unaffected arm with a sling or glove combined with intense task-oriented therapy of the affected side for six hours daily during 2 weeks. This pilot study will evaluate the effectiveness of sustained peripheral nerve stimulation coupled with functional motor training to improve hand motor function. While the functional motor training follows identical principles of CIT, the length of daily training will be shortened to 4 hours daily and thus the investigators will refer in this proposal as a modified CIT. Preliminary data for this study demonstrated that peripheral nerve stimulation results in increased cortical motor excitability in normal subjects. In addition, learning and use-dependent plasticity can be substantially enhanced by a single session of 2 hours of peripheral nerve stimulation in chronic stroke patients. The goal of this study is to test the hypothesis that stroke patients treated with upper extremity peripheral nerve stimulation preceding CIT (intervention group) will have improved hand motor function compared to a group receiving lower extremity peripheral nerve stimulation and CIT (control group).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: peripheral nerve stimulation2 hours of active peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training |
| Sham PNS | Sham comparator | Device: peripheral nerve stimulation2 hours of sham peripheral nerve stimulation paired with 4 hours of intensive task-oriented upper extremity training |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic stroke patients
- Single stroke
- Chronic (more than 12 months after from stroke)
- At least 21 years old, but there is no upper age range for this project.
- Participants must be able to extend the affected metacarpophalangeal joints at least 10° and the wrist 20°.
Key exclusion criteria (6 listed)
- History of carpal tunnel syndrome and conditions that commonly cause peripheral neuropathy, including diabetes, uremia, or associated nutritional deficiencies
- History of head injury with loss of consciousness, severe alcohol or drug abuse, psychiatric illness
- Within 3 months of recruitment, use of drugs known to exert detrimental effects on motor recovery
- Cognitive deficit severe enough to preclude informed consent
- Positive pregnancy test or being of childbearing age and not using appropriate contraception
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 stimulationNon-invasive stimulation of median, ulnar and radial nerves | Device | Active, Sham PNS |
Primary outcome
Change in Wolf Motor Function Test (WMFT), Timed Portion
Time frame: baseline, post-intervention, 1-month follow-up
Score at post-intervention minus score at baseline, score at 1-month follow-up minus score at baseline
2 secondary outcomes
Change in Fugl Meyer Assessment Motor Score
Time frame: baseline, post-intervention, 1-month follow-up
Change in Action Research Arm Test (ARAT)
Time frame: baseline, post-intervention, 1-month follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26945226Carrico C, Chelette KC 2nd, Westgate PM, Salmon-Powell E, Nichols L, Sawaki L. Randomized Trial of Peripheral Nerve Stimulation to Enhance Modified Constraint-Induced Therapy After Stroke. Am J Phys Med Rehabil. 2016 Jun;95(6):397-406. doi: 10.1097/PHM.0000000000000476.
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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 Phase 1/2 study testing peripheral nerve stimulation in people with Stroke and Cerebrovascular Accident, run by University of Kentucky.
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 6 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 13 Sep 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Wolf Motor Function Test (WMFT), Timed Portion (time frame: baseline, post-intervention, 1-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02587234, which also lists 1 linked publication.
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 13 Sep 2023.