StrokeNCT03124186
Sensory-driven Motor Recovery in Poorly Recovered Subacute Stroke Patients
A study testing S88 Dual Output Stimulator by Grass Technologies in people with Stroke and Cerebrovascular Accident, run by Lumy Sawaki.
Trial summary
This research project addresses a scientifically important question that cannot be answered by other means. The use of peripheral nerve stimulation has the potential to enhance recovery in subacute stroke patients with poor functional recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Accident
- What is being tested?
- S88 Dual Output Stimulator by Grass Technologies
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2008to 30 Jun 2013
- 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
- Having sustained a single ischemic or hemorrhagic stroke during the 3- to 12-month period preceding enrollment
- Single stroke
- Inability at the time of screening to demonstrate active extension of the affected metacarpophalangeal and interphalangeal joints at least 10°; and the wrist, 20° (ie, level of impairment that would preclude participation in constraint-induced therapy)
- Score of 47 or lower on the modified 30-item Fugl-Meyer Assessment of UE motor function
- Participants NOT 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
This research project addresses a scientifically important question that cannot be answered by other means. The use of peripheral nerve stimulation has the potential to enhance recovery in subacute stroke patients with poor functional recovery. The primary objective of this proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor training has the ability to further improve hand motor function when compared to intensive training alone or nerve stimulation alone. The results from this study have the potential to develop new strategies in neurorehabilitation.
Read the detailed description
Stroke is the leading cause of long-term disability in the United States. Approximately 70-88% of persons with ischemic stroke have some degree of motor impairment. A major goal of research in stroke rehabilitation is to harness the ability 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 (PNS) can be successfully combined to physical training, especially in poorly recovered subacute stroke patients. The proposed study will evaluate the effectiveness of sustained PNS coupled with motor training, to improve hand motor function in subacute stroke patients with severe motor deficit. Our preliminary data in chronic stroke patients with severe motor deficit demonstrate that motor function can be substantially enhanced when PNS is paired with motor training. In addition, a separate study in patients with mild motor deficit receiving motor training alone suggests that the optimal therapeutic time window to deliver motor training is within the first year after stroke. The improvement of behavioral motor function was associated with corticomotor reorganization. Therefore, this study proposes to evaluate the effectiveness of sustained PNS paired with motor training, to promote functional motor recovery in subacute stroke patients with severe motor deficit. The central hypothesis is that subacute stroke patients with severe motor deficit receiving PNS and intensive task-oriented therapy will have improved motor function compared to patients receiving sham-PNS and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation. The investigators plan to accept or reject the central hypothesis by accomplishing two Specific Aims: 1) test the effect of PNS preceding task-oriented therapy on hand motor function, and 2) test the effect of PNS preceding task-oriented therapy on motor map measured by transcranial magnetic stimulation. The long-range goals are: a) to maximize the restoration of hand motor function after stroke, b) to determine the impact of this intervention in activities of daily living, and c) collect solid data to prepare for a future multicenter randomized clinical trial.
- Conditions
- Stroke, Cerebrovascular Accident
- Being tested
- S88 Dual Output Stimulator by Grass Technologies
- Keywords
- motor recovery, neuroplasticity, subacute, human, sensory, nerve stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S88 Dual Output Stimulator by Grass TechnologiesDevice
Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation with motor training | Experimental | 2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies. Receives: Device: S88 Dual Output Stimulator by Grass Technologies |
| Sham stimulation with motor training | Active comparator | 2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies. Receives: Device: S88 Dual Output Stimulator by Grass Technologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl Meyer Assessment
The upper extremity FMA is a quantitative measure of motor recovery, sensation, coordination, and speed.
Measured: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Secondary outcomes (3)
Change in Action Arm Research Test (ARAT)
The ARAT was developed specifically to measure UE changes and consists of 4 specific tests to measure grasp, grip, pinch, and gross movement.
Measured: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Wolf Motor Function Test (WMFT)
The WMFT is a time- and function-based evaluation encompassing a battery of 17 tasks
Measured: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Stroke Impact Scale (SIS)
The SIS is a self-report measure that includes 64 items assessing 8 domains including strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation.
Measured: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Apr 2008
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumy Sawaki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lumy Sawaki, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124186
- Sponsor's protocol ID
- 5R01HD056002
- Status last verified
- Sep 2023
- First submitted
- 18 Apr 2017
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Carrico C, Westgate PM, Salmon Powell E, Chelette KC, Nichols L, Pettigrew LC, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Am J Phys Med Rehabil. 2018 Nov;97(11):808-815. doi: 10.1097/PHM.0000000000000971.
PubMed 29794530
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory-driven Motor Recovery in Poorly Recovered Subacute Stroke Patients
- ClinicalTrials.gov ID
- NCT03124186
- Acronym / sponsor ID
- 5R01HD056002
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- motor recovery, neuroplasticity, subacute, human, sensory, nerve stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Lumy SawakiUniversity, hospital or other
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 21 Apr 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 research project addresses a scientifically important question that cannot be answered by other means. The use of peripheral nerve stimulation has the potential to enhance recovery in subacute stroke patients with poor functional recovery. The primary objective of this proposal is to demonstrate that peripheral nerve stimulation combined with intensive motor training has the ability to further improve hand motor function when compared to intensive training alone or nerve stimulation alone. The results from this study have the potential to develop new strategies in neurorehabilitation.
Detailed description
Stroke is the leading cause of long-term disability in the United States. Approximately 70-88% of persons with ischemic stroke have some degree of motor impairment. A major goal of research in stroke rehabilitation is to harness the ability 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 (PNS) can be successfully combined to physical training, especially in poorly recovered subacute stroke patients. The proposed study will evaluate the effectiveness of sustained PNS coupled with motor training, to improve hand motor function in subacute stroke patients with severe motor deficit. Our preliminary data in chronic stroke patients with severe motor deficit demonstrate that motor function can be substantially enhanced when PNS is paired with motor training. In addition, a separate study in patients with mild motor deficit receiving motor training alone suggests that the optimal therapeutic time window to deliver motor training is within the first year after stroke. The improvement of behavioral motor function was associated with corticomotor reorganization. Therefore, this study proposes to evaluate the effectiveness of sustained PNS paired with motor training, to promote functional motor recovery in subacute stroke patients with severe motor deficit. The central hypothesis is that subacute stroke patients with severe motor deficit receiving PNS and intensive task-oriented therapy will have improved motor function compared to patients receiving sham-PNS and task-oriented therapy, and the degree of this behaviorally-measured effect will correlate with the neurophysiological effect measured by transcranial magnetic stimulation. The investigators plan to accept or reject the central hypothesis by accomplishing two Specific Aims: 1) test the effect of PNS preceding task-oriented therapy on hand motor function, and 2) test the effect of PNS preceding task-oriented therapy on motor map measured by transcranial magnetic stimulation. The long-range goals are: a) to maximize the restoration of hand motor function after stroke, b) to determine the impact of this intervention in activities of daily living, and c) collect solid data to prepare for a future multicenter randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation with motor training | Experimental | Device: S88 Dual Output Stimulator by Grass Technologies2 hours of active peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies. |
| Sham stimulation with motor training | Active comparator | Device: S88 Dual Output Stimulator by Grass Technologies2 hours of sham peripheral nerve stimulation (intervention) paired with 4 hours of intensive task-oriented upper extremity training. Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy. Peripheral nerve stimulation will be delivered using a S88 Dual Output Stimulator by Grass Technologies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having sustained a single ischemic or hemorrhagic stroke during the 3- to 12-month period preceding enrollment
- Single stroke
- Inability at the time of screening to demonstrate active extension of the affected metacarpophalangeal and interphalangeal joints at least 10°; and the wrist, 20° (ie, level of impairment that would preclude participation in constraint-induced therapy)
- Score of 47 or lower on the modified 30-item Fugl-Meyer Assessment of UE motor function
- Participants NOT 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 |
|---|---|---|
| S88 Dual Output Stimulator by Grass TechnologiesPeripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy | Device | Active stimulation with motor training, Sham stimulation with motor training |
Primary outcome
Change in Fugl Meyer Assessment
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
The upper extremity FMA is a quantitative measure of motor recovery, sensation, coordination, and speed.
3 secondary outcomes
Change in Action Arm Research Test (ARAT)
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Wolf Motor Function Test (WMFT)
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
Change in Stroke Impact Scale (SIS)
Time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline
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 2023.
- Derived from this study: PubMed 29794530Carrico C, Westgate PM, Salmon Powell E, Chelette KC, Nichols L, Pettigrew LC, Sawaki L. Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Am J Phys Med Rehabil. 2018 Nov;97(11):808-815. doi: 10.1097/PHM.0000000000000971.
- 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 S88 Dual Output Stimulator by Grass Technologies in people with Stroke and Cerebrovascular Accident, run by Lumy Sawaki.
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 11 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. 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?
Change in Fugl Meyer Assessment (time frame: Score change after 18 days of intervention compared to baseline; Score change after 1- and 4-month after the intervention compared to baseline). 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 NCT03124186, 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 11 Sep 2023.