StrokePhase 1/2NCT03292159
Transcutaneous Vagus Nerve Stimulation for Motor Recovery After Stroke
A Phase 1/2 study testing Active RAVANS concurrent with arm motor training and Inactive RAVANS concurrent with arm motor training in people with Stroke and Upper Extremity Paresis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- Active RAVANS concurrent with arm motor training and Inactive RAVANS concurrent with arm motor training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 20 Nov 2018
- Phase
- Phase 1/2
- 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
- Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
- Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
- Age ≥ 18;
- Able to provide written informed consent.
Who cannot join
- Implanted electronic device (e.g., pacemaker, neurostimulator);
- Pregnancy;
- Major psychiatric or medical condition that could interfere with study participation;
- Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
- Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score < 4 (scale: 0-5);
- History of seizure during year before stroke or > 1 post-stroke seizure;
Show all 14Show fewer
- Significant cognitive or language impairment that would interfere with informed consent or study participation;
- Severe dysphagia;
- Bradycardia defined as resting heart rate < 50 bpm;
- Nonsustained ventricular tachycardia;
- Cardiac conduction disorder (i.e., bundle branch block, heart block, long Q-T syndrome);
- History of asystole;
- History of recurrent vaso-vagal syncope;
- Hypotension defined as blood pressure < 90/60 mmHg.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
Official title: Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke
This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.
Read the detailed description
This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- Active RAVANS concurrent with arm motor training, Inactive RAVANS concurrent with arm motor training
- Keywords
- stroke, vagus nerve stimulation, upper extremity paresis
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RAVANS concurrent with arm motor trainingDevice
Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training
Inactive RAVANS concurrent with arm motor trainingDevice
Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
| Study group | Role | What they receive |
|---|---|---|
| RAVANS | Experimental | Not described Receives: Device: Active RAVANS concurrent with arm motor training |
| Sham stimulation | Sham comparator | Not described Receives: Device: Inactive RAVANS concurrent with arm motor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity motor impairment
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score
Measured: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Secondary outcomes (4)
Upper extremity motor function
Change in Action Research Arm Test (ARAT) score
Measured: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Grip force control
Change in accuracy, variability and temporal structure of performance on a grip force control task
Measured: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Upper extremity disability
Change in hand subtest of Stroke Impact Scale (SIS-hand) score
Measured: Baseline to 3 months post-stroke
Mood state, anxiety and depression
Change in Hospital Anxiety and Depression Scale (HADS) scores
Measured: Baseline to 3 months post-stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start17 May 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Why it stopped: funding not continued
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.
- More trials run by Massachusetts General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana Foundation, Spaulding Rehabilitation Hospital
- Responsible party
- Principal investigator, Judith Schaechter, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292159
- Sponsor's protocol ID
- 2017P000129
- Status last verified
- Sep 2021
- First submitted
- 20 Sep 2017
- Last updated
- 21 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Transcutaneous Vagus Nerve Stimulation Therapy to Improve Motor Recovery After Stroke
- ClinicalTrials.gov ID
- NCT03292159
- Acronym / sponsor ID
- 2017P000129
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- stroke, vagus nerve stimulation, upper extremity paresis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding not continued
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana Foundation, Spaulding Rehabilitation Hospital
- Study start
- 17 May 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 25 Sep 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 study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.
Detailed description
This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAVANS | Experimental | Device: Active RAVANS concurrent with arm motor training |
| Sham stimulation | Sham comparator | Device: Inactive RAVANS concurrent with arm motor training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Supratentorial ischemic or hemorrhagic stroke incurred 4-30 days prior;
- Contralesional UL motor impairment defined by NIHSS item 5 score 1 or 2 (scale 0-4);
- Age ≥ 18;
- Able to provide written informed consent.
Key exclusion criteria (14 listed)
- Implanted electronic device (e.g., pacemaker, neurostimulator);
- Pregnancy;
- Major psychiatric or medical condition that could interfere with study participation;
- Medical condition affecting left ear that could interfere with delivering RAVANS (e.g., wound, infection, malignancy, hypoesthesia);
- Significant pre-existing disability of stroke-affected UL in activities of daily living due to prior stroke or other medical cause defined by Stroke Impact Scale item 7 (SIS-hand) mean score < 4 (scale: 0-5);
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 |
|---|---|---|
| Active RAVANS concurrent with arm motor trainingPatient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training | Device | RAVANS |
| Inactive RAVANS concurrent with arm motor trainingPatient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training | Device | Sham stimulation |
Primary outcome
Upper extremity motor impairment
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score
4 secondary outcomes
Upper extremity motor function
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Grip force control
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Upper extremity disability
Time frame: Baseline to 3 months post-stroke
Mood state, anxiety and depression
Time frame: Baseline to 3 months post-stroke
Results and safety
The study was stopped early (reason given: funding not continued). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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 Phase 1/2 study testing Active RAVANS concurrent with arm motor training and Inactive RAVANS concurrent with arm motor training in people with Stroke and Upper Extremity Paresis, run by Massachusetts General Hospital 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 4 inclusion and 14 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 21 Sep 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.
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?
The study was stopped early (reason given: funding not continued). 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?
Upper extremity motor impairment (time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke). 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 21 Sep 2021.