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At-Home taVNS for Neurorehabilitation in Parkinson's Disease

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Summary

NIH registered a new clinical trial (NCT07536022) evaluating at-home transcutaneous auricular vagus nerve stimulation (taVNS) for neurorehabilitation in approximately 40 adults with Parkinson's Disease. The 8-week study will assess feasibility, tolerability, and preliminary efficacy of self-administered daily 1-hour taVNS sessions using a threshold-based individual dosing protocol. Secondary objectives include measuring changes in motor and non-motor symptoms and examining neural network connectivity via MRI.

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What changed

NIH registered a new clinical trial on ClinicalTrials.gov studying at-home transcutaneous auricular vagus nerve stimulation (taVNS) as a potential neurorehabilitation treatment for Parkinson's Disease. The single-arm feasibility study will enroll approximately 40 adult participants who will self-administer 1-hour daily taVNS sessions for 8 weeks following threshold measurement and initial supervised training with vital monitoring.

For clinical investigators and researchers focused on neuromodulation or movement disorders, this trial represents a novel application of non-invasive vagus nerve stimulation for neurodegenerative disease. Medical device manufacturers developing or marketing taVNS or similar peripheral nerve stimulation devices should monitor enrollment outcomes and preliminary efficacy data, as positive results could support expanded clinical development or regulatory submissions. Patients with Parkinson's Disease may wish to discuss trial participation eligibility with their neurologists.

Archived snapshot

Apr 18, 2026

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At-home taVNS for Neurorehabilitation in Parkinson's Disease

N/A NCT07536022 Kind: NA Apr 17, 2026

Abstract

The goal of this clinical trial is to learn if taVNS works to treat symptoms of Parkinson's Disease in adults. It will also learn about the feasibility and preliminary efficacy of taVNS administered at home by the participant.

The main questions it aims to answer are:

  1. Is at-home taVNS feasible and effective for treating symptoms of Parkinson's Disease? How often are participants completing the stimulation protocol? What are the side effects of stimulation experienced by participants? How do participants rate the experience of taVNS sessions at home? How do participants' scores on assessments and questionnaires change with taVNS treatments?
  2. How does taVNS impact connections between neural networks in the brain of patients with Parkinson's Disease at rest?

Participants will:

  • Have a baseline MRI scan to take images of their brain.
  • Complete a series of assessments and questionnaires to evaluate their Parkinson's Disease motor symptoms, cognitive and neuropsychiatric symptoms, and other non-motor symptoms.
  • Have an initial taVNS session where their threshold to perceive the stimulation will be measured. This value will be used to stimulate each participant at a specific dose relative to their individual perception of stimulation.
  • Be trained on how to use the taVNS device and system and have one 1-hour taVNS session where their vitals will be monitored.
  • Self-administer 1-hour daily taVNS sessions for 8 weeks at-home, complete tolerability questionnaires, and w...

Conditions: Parkinson's Disease

Interventions: transcutaneous auricular nerve stimulation

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Named provisions

Transcutaneous auricular vagus nerve stimulation Parkinson's Disease Feasibility and efficacy study

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Last updated

Classification

Agency
NIH
Published
April 17th, 2024
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07536022

Who this affects

Applies to
Clinical investigators Medical device makers Patients
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Clinical trial registration Medical device research Neurorehabilitation
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals Public Health

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