Stroke RehabilitationsVNS-rehabNCT06623721
Movement-activated Auricular Vagus Nerve Stimulation in Rehabilitation
A study testing Movement-evoked transcutaneous auricular Vagus nerve stimulation in people with Stroke Rehabilitation and Neurorehabilitation, run by Olivier Lambercy at 1 site in Switzerland.
Trial summary
Rehabilitation engineering laboratory (RELab) at the ETH Zurich is recruiting participants with a motor function deficit for studying a novel non-invasive brain stimulation method that may be a promising approach for benefiting motor recovery after conditions like stroke, traumatic brain injury or spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Rehabilitation, Neurorehabilitation
- What is being tested?
- Movement-evoked transcutaneous auricular Vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Nov 2024to 3 Oct 2025
- 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
- Age ≥ 18 years
- Ability to follow study instructions
- At least 1-2 weeks after a stroke or traumatic brain/spinal cord injury and with a residual motor deficit.
Who cannot join
- Inability to give informed consent or understand the tasks, other neurological or psychiatric illness that could confound execution/recovery. E.g. Global inattention or receptive aphasia.
- Presence of ongoing dysphagia or aspiration difficulties
- Subject receiving medication that may significantly interfere with actions of taVNS on neurotransmitter systems at study enrollment
- Prior injury to vagus nerve, either bilateral or unilateral (e.g., injury during carotid endarterectomy)
- Severe depression (Beck Depression Scale \> 29)
- Current use of any implanted electronic device, such as a pacemaker or other neurostimulator
Show all 9Show fewer
- Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent the subject from meeting protocol timeline
- Pregnancy or plans to become pregnant or to breastfeed during the study period
- Current requirement, or likely future requirement, of diathermy during the study duration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Tolerance of Movement-activated Auricular Vagus Nerve Stimulation in Motor Rehabilitation
Rehabilitation engineering laboratory (RELab) at the ETH Zurich is recruiting participants with a motor function deficit for studying a novel non-invasive brain stimulation method that may be a promising approach for benefiting motor recovery after conditions like stroke, traumatic brain injury or spinal cord injury. The study will be conducted at the cereneo Hertenstein clinic. Participants with residual motor function deficit due to stroke or spine/brain injury will be undergoing typical neurorehabilitation procedures in addition to the use of the automatically controlled non-invasive Vagus nerve stimulation (taVNS).
This study will analyze the feasibility of this method before it can be used by doctors generally. More specifically, this study aims to test whether controlling taVNS with a wearable wrist-worn sensor during rehabilitation exercises for movement is both practical and safe. This stimulation works by involves sending tiny electric pulses to the outside of the ear after the wrist sensor detects movement. These pulses activate the auricular Vagus nerve and in turn the brain. Over the course of multiple rehabilitation procedures, taVNS may to help with the speed of motor recovery as shown with previous, manually controlled studies. The goal of this study is wants to see if the automatically controlled taVNSs method works well and doesn\'t cause any harm while people are doing their therapy exercises. If successful, in the future it could offer a new way to improve the recovery process movement for people with motor difficulties.
Read the detailed description
Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a safe and medically approved non-invasive method for stimulating the vagus nerve, utilising a small electrode placed on the outer ear to transcutaneously activate an auricular branch of the vagus nerve. Studies indicate the potential benefits of both invasive and non-invasive vagus nerve stimulation for motor neurorehabilitation, particularly when combined with rehabilitation exercises. A recent pilot study has shown that pairing motor rehabilitation with taVNS in a movement-gated system resulted in improvement on Fugl-Meyer Assessment upper extremity scores and a greater effect size compared to an unpaired taVNS, while administering fewer stimulation pulses. This demonstrates that taVNS paired with movement therapy can reduce the intensity of stimulation, while still producing beneficial results. However, current approaches for performing stimulation during movement require either manual control or complex and non-specific sensor setup. There are no options for tracking and controlling stimulation based on movement kinematics in an objective, unsupervised manner. Therefore, an in-house developed taVNS system will be used (SmartVNS). The system includes inertial measurement unit (IMU) sensors to track patient's movement and then automatically initiates the taVNS stimulation during movements.
The benefit for participants in the study involving transcutaneous auricular vagus nerve stimulation (taVNS) paired with rehabilitation exercises outweighs the potential risks. The intervention, taVNS, is a medically approved procedure with minimal and extremely rare adverse effects, particularly when used within approved parameters. The study protocol ensures that taVNS will be administered at safe and tolerable intensity levels, with immediate removal of electrodes if any discomfort occurs. Additionally, the intervention will not alter the typical rehabilitation program of the participants, and motion-triggered taVNS will be while participants perform repetitive rehabilitation exercise movements with the affected limb. The potential benefits of the study include contributing to the quality of future neurorehabilitation outcomes and informing decisions for protocols in future clinical studies to explore the efficacy of taVNS in enhancing neurorehabilitation and motor learning in adults with motor deficits. Overall, the study aims to prioritise participant safety while offering the potential for meaningful therapeutic benefits.
- Conditions
- Stroke Rehabilitation, Neurorehabilitation
- Being tested
- Movement-evoked transcutaneous auricular Vagus nerve stimulation
- Keywords
- neurorehabilitation, feasibility, vagus, stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-evoked transcutaneous auricular Vagus nerve stimulationDevice
Intervention requires wearing of an inertial measurement unit (IMU) sensor on an affected upper limb together with a transcutaneous auricular Vagus nerve (taVNS) stimulator on an outer ear on the contralateral side.
Intervention involves IMU measurement-evoked initiation of taVNS during conventional neurorehabilitation therapy that is defined by the patient\'s doctor and therapist. Typically this is around 60 minutes/day of 50-300 repetitive upper limb movements targeting specific deficits such as flexor synergies and/or wrist, triceps or shoulder activation.
taVNS intensity is calibrated at the start of every neurorehabilitation session by the patient to the maximal comfortable level with instructions to avoid pain or any serious discomfort. Patient is always accompanied by a therapist trained in the use of taVNS and the device is easy to immediately remove should any discomfort occur.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients undergoing prescribed neurorehabilitation therapy with additional intervention of movement-evoked auricular Vagus nerve stimulation. Receives: Device: Movement-evoked transcutaneous auricular Vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of automatic movement-initiated taVNS
Perceived feasibility of automatic movement-initiated taVNS, assessed through validated questionnaires. This includes subjective ratings on ease of use, comfort, and perceived effects by therapists and patients. Questionnaires include: UMUX, IMI and UE.
Measured: From enrollment to the end of treatment at 2 or at 4 weeks with an additional follow-up at 1 week after
Secondary outcomes (4)
Feasibility of automatic movement detection during therapy
Agreement between manual movement detection by therapists and automatic sensor-triggered stimulation timings, based on ground-truth video recording, assessing technical feasibility.
Measured: On the first and last sessions of the study at weeks 1 and 2 or 4.
Tolerance and safety
Recording incidences of adverse events and subjective unstructured feedback.
Measured: From enrollment to the end of treatment at 2 or at 4 weeks.
Motor deficit
Analysis of routine clinical assessments of motor deficit using the Fugl-Meyer Assessment for upper extremity (FMA-UE). Higher FMA-UE scores indicate reduction of deficit and improvement in patient\'s motor skills. Comparison of post-rehabilitation against baseline to ensure no deterioration, using statistical comparison of evaluation of standard clinical assessments performed during patients stay.
Measured: From enrollment to the end of treatment at 2 or at 4 weeks.
Mood assessment
Description: Analysis of routine clinical assessments of assessning mood by using the Hospital Anxiety and Depression Scale (HADS). High scores indicate abnormal anxiety and/or depression. Comparison of post-rehabilitation against baseline to ensure no deterioration, using statistical comparison of evaluation of standard clinical assessments performed during patients stay.
Time Frame: From enrollment to the end of treatment at 2 or at 4 weeks.
Measured: From enrollment to the end of treatment at 2 or at 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start27 Nov 2024
- Primary completion3 Oct 2025 (estimated)
- Study completion3 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier Lambercy
- Sponsor type
- University, hospital or other
- Collaborators
- Cereneo AG
- Responsible party
- Sponsor-investigator, Olivier Lambercy, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623721
- Sponsor's protocol ID
- SmartVNSNeuroRehab
- Other IDs
- 2024-01425
- Acronym
- sVNS-rehab
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned.
Publications
Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
PubMed 37209010Baig SS, Kamarova M, Bell SM, Ali AN, Su L, Dimairo M, Dawson J, Redgrave JN, Majid A. tVNS in Stroke: A Narrative Review on the Current State and the Future. Stroke. 2023 Oct;54(10):2676-2687. doi: 10.1161/STROKEAHA.123.043414. Epub 2023 Aug 30.
PubMed 37646161Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
PubMed 33894832
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Tolerance of Movement-activated Auricular Vagus Nerve Stimulation in Motor Rehabilitation
- ClinicalTrials.gov ID
- NCT06623721
- Acronym / sponsor ID
- sVNS-rehab / SmartVNSNeuroRehab
- Conditions
- Stroke Rehabilitation, Neurorehabilitation
- Keywords
- neurorehabilitation, feasibility, vagus, stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Olivier LambercyUniversity, hospital or other
- Collaborators
- Cereneo AG
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 3 Oct 2025 (estimated)
- Study completion
- 3 Oct 2025 (estimated)
- First posted
- 2 Oct 2024 (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.
Rehabilitation engineering laboratory (RELab) at the ETH Zurich is recruiting participants with a motor function deficit for studying a novel non-invasive brain stimulation method that may be a promising approach for benefiting motor recovery after conditions like stroke, traumatic brain injury or spinal cord injury. The study will be conducted at the cereneo Hertenstein clinic. Participants with residual motor function deficit due to stroke or spine/brain injury will be undergoing typical neurorehabilitation procedures in addition to the use of the automatically controlled non-invasive Vagus nerve stimulation (taVNS).
This study will analyze the feasibility of this method before it can be used by doctors generally. More specifically, this study aims to test whether controlling taVNS with a wearable wrist-worn sensor during rehabilitation exercises for movement is both practical and safe. This stimulation works by involves sending tiny electric pulses to the outside of the ear after the wrist sensor detects movement. These pulses activate the auricular Vagus nerve and in turn the brain. Over the course of multiple rehabilitation procedures, taVNS may to help with the speed of motor recovery as shown with previous, manually controlled studies. The goal of this study is wants to see if the automatically controlled taVNSs method works well and doesn\'t cause any harm while people are doing their therapy exercises. If successful, in the future it could offer a new way to improve the recovery process movement for people with motor difficulties.
Detailed description
Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a safe and medically approved non-invasive method for stimulating the vagus nerve, utilising a small electrode placed on the outer ear to transcutaneously activate an auricular branch of the vagus nerve. Studies indicate the potential benefits of both invasive and non-invasive vagus nerve stimulation for motor neurorehabilitation, particularly when combined with rehabilitation exercises. A recent pilot study has shown that pairing motor rehabilitation with taVNS in a movement-gated system resulted in improvement on Fugl-Meyer Assessment upper extremity scores and a greater effect size compared to an unpaired taVNS, while administering fewer stimulation pulses. This demonstrates that taVNS paired with movement therapy can reduce the intensity of stimulation, while still producing beneficial results. However, current approaches for performing stimulation during movement require either manual control or complex and non-specific sensor setup. There are no options for tracking and controlling stimulation based on movement kinematics in an objective, unsupervised manner. Therefore, an in-house developed taVNS system will be used (SmartVNS). The system includes inertial measurement unit (IMU) sensors to track patient's movement and then automatically initiates the taVNS stimulation during movements.
The benefit for participants in the study involving transcutaneous auricular vagus nerve stimulation (taVNS) paired with rehabilitation exercises outweighs the potential risks. The intervention, taVNS, is a medically approved procedure with minimal and extremely rare adverse effects, particularly when used within approved parameters. The study protocol ensures that taVNS will be administered at safe and tolerable intensity levels, with immediate removal of electrodes if any discomfort occurs. Additionally, the intervention will not alter the typical rehabilitation program of the participants, and motion-triggered taVNS will be while participants perform repetitive rehabilitation exercise movements with the affected limb. The potential benefits of the study include contributing to the quality of future neurorehabilitation outcomes and informing decisions for protocols in future clinical studies to explore the efficacy of taVNS in enhancing neurorehabilitation and motor learning in adults with motor deficits. Overall, the study aims to prioritise participant safety while offering the potential for meaningful therapeutic benefits.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Movement-evoked transcutaneous auricular Vagus nerve stimulationPatients undergoing prescribed neurorehabilitation therapy with additional intervention of movement-evoked auricular Vagus nerve stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Ability to follow study instructions
- At least 1-2 weeks after a stroke or traumatic brain/spinal cord injury and with a residual motor deficit.
Key exclusion criteria (9 listed)
- Inability to give informed consent or understand the tasks, other neurological or psychiatric illness that could confound execution/recovery. E.g. Global inattention or receptive aphasia.
- Presence of ongoing dysphagia or aspiration difficulties
- Subject receiving medication that may significantly interfere with actions of taVNS on neurotransmitter systems at study enrollment
- Prior injury to vagus nerve, either bilateral or unilateral (e.g., injury during carotid endarterectomy)
- Severe depression (Beck Depression Scale \> 29)
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 |
|---|---|---|
| Movement-evoked transcutaneous auricular Vagus nerve stimulationIntervention requires wearing of an inertial measurement unit (IMU) sensor on an affected upper limb together with a transcutaneous auricular Vagus nerve (taVNS) stimulator on an outer ear on the contralateral side. Intervention involves IMU measurement-evoked initiation of taVNS during conventional neurorehabilitation therapy that is defined by the patient\'s doctor and therapist. Typically this is around 60 minutes/day of 50-300 repetitive upper limb movements targeting specific deficits such as flexor synergies and/or wrist, triceps or shoulder activation. taVNS intensity is calibrated at the start of every neurorehabilitation session by the patient to the maximal comfortable level with instructions to avoid pain or any serious discomfort. Patient is always accompanied by a therapist trained in the use of taVNS and the device is easy to immediately remove should any discomfort occur. | Device | Intervention |
Primary outcome
Feasibility of automatic movement-initiated taVNS
Time frame: From enrollment to the end of treatment at 2 or at 4 weeks with an additional follow-up at 1 week after
Perceived feasibility of automatic movement-initiated taVNS, assessed through validated questionnaires. This includes subjective ratings on ease of use, comfort, and perceived effects by therapists and patients. Questionnaires include: UMUX, IMI and UE.
4 secondary outcomes
Feasibility of automatic movement detection during therapy
Time frame: On the first and last sessions of the study at weeks 1 and 2 or 4.
Tolerance and safety
Time frame: From enrollment to the end of treatment at 2 or at 4 weeks.
Motor deficit
Time frame: From enrollment to the end of treatment at 2 or at 4 weeks.
Mood assessment
Time frame: From enrollment to the end of treatment at 2 or at 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Background: PubMed 37209010Badran BW, Peng X, Baker-Vogel B, Hutchison S, Finetto P, Rishe K, Fortune A, Kitchens E, O'Leary GH, Short A, Finetto C, Woodbury ML, Kautz S. Motor Activated Auricular Vagus Nerve Stimulation as a Potential Neuromodulation Approach for Post-Stroke Motor Rehabilitation: A Pilot Study. Neurorehabil Neural Repair. 2023 Jun;37(6):374-383. doi: 10.1177/15459683231173357. Epub 2023 May 20.
- Background: PubMed 37646161Baig SS, Kamarova M, Bell SM, Ali AN, Su L, Dimairo M, Dawson J, Redgrave JN, Majid A. tVNS in Stroke: A Narrative Review on the Current State and the Future. Stroke. 2023 Oct;54(10):2676-2687. doi: 10.1161/STROKEAHA.123.043414. Epub 2023 Aug 30.
- Background: PubMed 33894832Dawson J, Liu CY, Francisco GE, Cramer SC, Wolf SL, Dixit A, Alexander J, Ali R, Brown BL, Feng W, DeMark L, Hochberg LR, Kautz SA, Majid A, O'Dell MW, Pierce D, Prudente CN, Redgrave J, Turner DL, Engineer ND, Kimberley TJ. Vagus nerve stimulation paired with rehabilitation for upper limb motor function after ischaemic stroke (VNS-REHAB): a randomised, blinded, pivotal, device trial. Lancet. 2021 Apr 24;397(10284):1545-1553. doi: 10.1016/S0140-6736(21)00475-X.
- Individual participant dataSharing planned: No. Not planned.
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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 Movement-evoked transcutaneous auricular Vagus nerve stimulation in people with Stroke Rehabilitation and Neurorehabilitation, run by Olivier Lambercy at 1 site in Switzerland.
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 3 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: status not confirmed, as of the sponsor's last update on 29 Nov 2024. 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 Switzerland. 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?
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?
Feasibility of automatic movement-initiated taVNS (time frame: From enrollment to the end of treatment at 2 or at 4 weeks with an additional follow-up at 1 week after). 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 NCT06623721, which also lists 3 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 29 Nov 2024.