StrokeNCT02243020
VNS During Rehabilitation for Improved Upper Limb Motor Function After Stroke
A study testing Vagus Nerve Stimulation (VNS) in people with Stroke and Upper Limb Deficits, run by MicroTransponder Inc. at 3 sites in United States.
Trial summary
The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke, Upper Limb Deficits
- What is being tested?
- Vagus Nerve Stimulation (VNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2014to 1 Jun 2022
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
- Age >30 years and <80 years
- Right or left sided weakness of upper extremity
- UEFM score within designated range.
- At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits
Who cannot join
- History of hemorrhagic stroke
- Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
- Significant sensory loss.
- Presence of ongoing dysphagia or aspiration difficulties.
- Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
- Subject receiving any therapy (medication or otherwise) at study entry that would interfere with VNS (e.g. drugs that interfere with neurotransmitter mechanisms). Additionally, no psychoactive medications - including nicotine - may be used during the acute study.
Show all 17Show fewer
- Prior injury to vagus nerve - either bilateral or unilateral (e.g., injury during carotid endarterectomy)
- Severe depression
- Not considered candidate for a device implant surgery (history of adverse reactions to anesthetics, poor surgical candidate in surgeon's opinion, etc.)
- Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse)
- Pregnant or plan on becoming pregnant or breastfeeding during the study period
- Currently require, or likely to require, diathermy during the study duration
- Any health problem requiring surveillance with MRI imaging
- Active rehabilitation within 4-weeks prior to therapy
- Botox injections or any other non-study active rehabilitation of the upper extremity 4-weeks prior to and during therapy
- Severe spasticity of the upper limb
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UT Southwestern
Dallas, Texas
UT Houston
Houston, Texas, 77030
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)
The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.
- Conditions
- Stroke, Upper Limb Deficits
- Being tested
- Vagus Nerve Stimulation (VNS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve Stimulation (VNS)Device
Also called VNS
| Study group | Role | What they receive |
|---|---|---|
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Experimental | This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. Receives: Device: Vagus Nerve Stimulation (VNS) |
| Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | Active comparator | This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation. Receives: Device: Vagus Nerve Stimulation (VNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Extremity Fugl-Meyer (UEFM)
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
Measured: 6-weeks
Secondary outcomes (1)
Change in Wolf Motor Function Test Functional Assessment (WMFT)
Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016
- Study completion1 Jun 2022
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 (5)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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroTransponder Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patty Smith, Ph.D., Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243020
- Sponsor's protocol ID
- MT-St-02
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2014
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.
PubMed 30355189Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.
PubMed 31903435Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.
PubMed 31685853Beovich A, Boose J, Patel R, Wolf SL. Vagus Nerve Stimulation Paired With Rehabilitation for Chronic Stroke: Characterizing Responders. J Neurol Phys Ther. 2024 Oct 1;48(4):217-223. doi: 10.1097/NPT.0000000000000488. Epub 2024 Sep 17.
PubMed 39028576Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.
PubMed 32476617
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study MT-St-02 - Stroke - A Randomized Pilot Study Assessing Vagus Nerve Stimulation (VNS) During Rehabilitation for Improved Upper Limb Motor Function After Stroke (MicroTransponder's Vivistim System)
- ClinicalTrials.gov ID
- NCT02243020
- Acronym / sponsor ID
- MT-St-02
- Conditions
- Stroke, Upper Limb Deficits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- MicroTransponder Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 17 Sep 2014 (estimated)
- Results
- Posted 15 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.
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 |
|---|---|---|
| Vagus Nerve Stimulation (VNS) + Rehabilitation (1) | Experimental | Device: Vagus Nerve Stimulation (VNS)This group receives vagus nerve stimulation during rehabilitation. VNS and rehabilitation are the interventions. |
| Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator | Active comparator | Device: Vagus Nerve Stimulation (VNS)This group receives rehabilitation and VNS, but the VNS is different than given in the other group (rehabilitation is the only true intervention in this group). It may not be as effective as the other group's settings. Both groups receive the same amount of rehabilitation. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of ischemic stroke that occurred at least 4 months prior to enrollment, but not more than 24 months prior
- Age >30 years and <80 years
- Right or left sided weakness of upper extremity
- UEFM score within designated range.
- At least 10 degrees of wrist extension, 10° of thumb abduction/extension, and at least 10° of extension in at least 2 additional digits
Key exclusion criteria (17 listed)
- History of hemorrhagic stroke
- Any deficits in language or cognitive functioning that hinders participation, for example, (aphasia) or unable to follow 2 step commands.
- Significant sensory loss.
- Presence of ongoing dysphagia or aspiration difficulties.
- Active major neurological or psychiatric diagnosis that would likely interfere with study protocol including prior history of brain lesions (including dementia, etc.), and current alcohol abuse, drug abuse, or epilepsy.
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 |
|---|---|---|
| Vagus Nerve Stimulation (VNS)Also: VNS | Device | Vagus Nerve Stim (VNS) + Rehabilitation (2) - Comparator, Vagus Nerve Stimulation (VNS) + Rehabilitation (1) |
Primary outcome
Change in Upper Extremity Fugl-Meyer (UEFM)
Time frame: 6-weeks
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
1 secondary outcome
Change in Wolf Motor Function Test Functional Assessment (WMFT)
Time frame: 6-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30355189Kimberley TJ, Pierce D, Prudente CN, Francisco GE, Yozbatiran N, Smith P, Tarver B, Engineer ND, Alexander Dickie D, Kline DK, Wigginton JG, Cramer SC, Dawson J. Vagus Nerve Stimulation Paired With Upper Limb Rehabilitation After Chronic Stroke. Stroke. 2018 Nov;49(11):2789-2792. doi: 10.1161/STROKEAHA.118.022279.
- Results publication: PubMed 31903435Kimberley TJ, Prudente CN, Engineer ND, Pierce D, Tarver B, Cramer SC, Dickie DA, Dawson J. Study protocol for a pivotal randomised study assessing vagus nerve stimulation during rehabilitation for improved upper limb motor function after stroke. Eur Stroke J. 2019 Dec;4(4):363-377. doi: 10.1177/2396987319855306. Epub 2019 Jun 17.
- Results publication: PubMed 31685853Dickie DA, Kimberley TJ, Pierce D, Engineer N, Tarver WB, Dawson J. An Exploratory Study of Predictors of Response to Vagus Nerve Stimulation Paired with Upper-Limb Rehabilitation After Ischemic Stroke. Sci Rep. 2019 Nov 4;9(1):15902. doi: 10.1038/s41598-019-52092-x.
- Derived from this study: PubMed 39028576Beovich A, Boose J, Patel R, Wolf SL. Vagus Nerve Stimulation Paired With Rehabilitation for Chronic Stroke: Characterizing Responders. J Neurol Phys Ther. 2024 Oct 1;48(4):217-223. doi: 10.1097/NPT.0000000000000488. Epub 2024 Sep 17.
- Derived from this study: PubMed 32476617Dawson J, Engineer ND, Prudente CN, Pierce D, Francisco G, Yozbatiran N, Tarver WB, Casavant R, Kline DK, Cramer SC, Van de Winckel A, Kimberley TJ. Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up. Neurorehabil Neural Repair. 2020 Jul;34(7):609-615. doi: 10.1177/1545968320924361. Epub 2020 Jun 1.
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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.
Patty Smith, Ph.D. principal investigator
UT Southwestern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation (VNS) in people with Stroke and Upper Limb Deficits, run by MicroTransponder Inc. at 3 sites 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 5 inclusion and 17 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 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Yes. Results are posted in the registry (first posted 15 May 2019). 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 Upper Extremity Fugl-Meyer (UEFM) (time frame: 6-weeks). 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 NCT02243020, which also lists 5 linked publications.
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 Sep 2022.