Movement-activated Auricular Vagus Nerve Stimulation in Rehabilitation

NCT06623721 | Enrolling By Invitation

• 2 other identifiers: SmartVNSNeuroRehab2024-01425
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke Rehabilitation; Neurorehabilitation

Keywords

neurorehabilitation; feasibility; vagus; stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  On the first and last sessions of the study at weeks 1 and 2 or 4.

• Tolerance and safety

  From enrollment to the end of treatment at 2 or at 4 weeks.

• Motor deficit

  From enrollment to the end of treatment at 2 or at 4 weeks.

• Mood assessment

  From enrollment to the end of treatment at 2 or at 4 weeks.

Study Arms (1)

Intervention

EXPERIMENTAL

Patients undergoing prescribed neurorehabilitation therapy with additional intervention of movement-evoked auricular Vagus nerve stimulation.

Device: Movement-evoked transcutaneous auricular Vagus nerve stimulation

Interventions

Movement-evoked transcutaneous auricular Vagus nerve stimulation DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Olivier Lambercy: lead
• Cereneo AG: collaborator

Study Sites (1)

Cereneo Hertenstein

Weggis, 6353, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 37209010 BACKGROUND

• Baig 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.

  PMID: 37646161 BACKGROUND

• Dawson 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.

  PMID: 33894832 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Adjunct Professor and the Deputy Director of the Rehabilitation Engineering Laboratory at ETH Zurich

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 2, 2024
• Study Start: November 27, 2024
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)