Neurological InjuryNCT05316519
Transcutaneous Auricular Vagus Nerve Stimulation to Enhance Motor Learning
A study testing Transcutaneous Vagus Nerve Stimulation in people with Neurological Injury and Motor Disorders, run by VA Pittsburgh Healthcare System at 1 site in United States.
Trial summary
Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurological Injury, Motor Disorders, Paresis
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 31 Dec 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (For prospective subjects diagnosed with stroke)
- Confirmed diagnosis of a single stroke at least six months prior to participation
Who cannot join
- History of vestibular disorders or dizziness
- Diagnosis of neurological disorders affecting movement
- Ocular disease and/or impairment in more than one eye
- Pregnant or expecting to become pregnant
- Difficulty maintaining alertness and/or remaining still
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Engineering Research Laboratories
Pittsburgh, Pennsylvania, 15206
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential
Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning.
- Conditions
- Neurological Injury, Motor Disorders, Paresis
- Being tested
- Transcutaneous Vagus Nerve Stimulation
- Medical subject headings
- Trauma, Nervous System, Motor Disorders, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationOther
Visuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Experimental | Transcutaneous vagus nerve stimulation paired with visuomotor task training Receives: Other: Transcutaneous Vagus Nerve Stimulation |
| Transcutaneous Stimulation (Sham) | Placebo comparator | Transcutaneous stimulation paired with visuomotor task training Receives: Other: Transcutaneous Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision grip stability (coefficient of variation or root-mean-square error)
The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force.
Measured: 1 month post training
Secondary outcomes (1)
Force signal composition (Fourier transform)
The force signal oscillates at various frequencies and will be decomposed with a Fourier transform to quantify the relative contribution of higher frequencies.
Measured: 1 month post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start1 Jun 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Pilot protocol terminated to begin trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sham-controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Pittsburgh Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Michael A. Urbin, VA Pittsburgh Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316519
- Sponsor's protocol ID
- 1619399
- Status last verified
- May 2024
- First submitted
- 16 Mar 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation: Mechanisms and Therapeutic Potential
- ClinicalTrials.gov ID
- NCT05316519
- Acronym / sponsor ID
- 1619399
- Conditions
- Neurological Injury, Motor Disorders, Paresis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pilot protocol terminated to begin trial.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- VA Pittsburgh Healthcare SystemUS federal agency
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Apr 2022 (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.
Vagus nerve stimulation (VNS) activates neural pathways leading to the release of chemicals that promote plasticity and learning. Previous work has shown that the auricular branch of the vagus nerve innervates landmarks on the external ear. Work from the PI's laboratory has shown that electrical current applied to the external ear activates neural pathways implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms that are modulated by auricular stimulation and its potential to enhance motor learning.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Sham-controlled
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Experimental | Other: Transcutaneous Vagus Nerve StimulationTranscutaneous vagus nerve stimulation paired with visuomotor task training |
| Transcutaneous Stimulation (Sham) | Placebo comparator | Other: Transcutaneous Vagus Nerve StimulationTranscutaneous stimulation paired with visuomotor task training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (For prospective subjects diagnosed with stroke)
- Confirmed diagnosis of a single stroke at least six months prior to participation
Key exclusion criteria (5 listed)
- History of vestibular disorders or dizziness
- Diagnosis of neurological disorders affecting movement
- Ocular disease and/or impairment in more than one eye
- Pregnant or expecting to become pregnant
- Difficulty maintaining alertness and/or remaining still
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 |
|---|---|---|
| Transcutaneous Vagus Nerve StimulationVisuomotor task training with transcutaneous stimulation targeting landmark that activates biomarker | Other | Transcutaneous Stimulation (Sham), Transcutaneous Vagus Nerve Stimulation |
Primary outcome
Precision grip stability (coefficient of variation or root-mean-square error)
Time frame: 1 month post training
The ability to stabilize precision grip according to target force and/or preload force will be quantified by calculating coefficient of variation (CV) or root-mean-square error (RMSE) which characterize variability in relation to mean force or target force.
1 secondary outcome
Force signal composition (Fourier transform)
Time frame: 1 month post training
Results and safety
The study was stopped early (reason given: Pilot protocol terminated to begin trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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 Transcutaneous Vagus Nerve Stimulation in people with Neurological Injury and Motor Disorders, run by VA Pittsburgh Healthcare System 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 2 inclusion and 5 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 9 May 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 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.
Are results available for this study?
The study was stopped early (reason given: Pilot protocol terminated to begin trial.). 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?
Precision grip stability (coefficient of variation or root-mean-square error) (time frame: 1 month post training). 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 9 May 2024.