ParesisNCT06282406
Pupil-Indexed Noninvasive Neuromodulation
A study testing Transcutaneous Electrical Stimulation in people with Paresis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which 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
- Paresis
- What is being tested?
- Transcutaneous Electrical Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 5 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ALL PROSPECTIVE SUBJECTS:
- 18-75 years of age
- PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
- Diagnosis of a single stroke resulting in hand impairment
- Diagnosis of stroke at least six months prior to the time of participation
Who cannot join
- ALL PROSPECTIVE SUBJECTS:
- History of vestibular disorders or dizziness
- Difficulty maintaining alertness and/or remaining still
- Pregnant or expecting to become pregnant
- Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
- Ocular disease and/or impairment in more than one eye
Show all 12Show fewer
- History of seizure and/or epilepsy
- Implants, devices, or foreign objects in the brain/body that are incompatible with MRI
- Body size that is incompatible with MRI scanner dimensions
- Anyone already enrolled and actively participating in another greater than minimal risk study.
- PROSPECTIVE SUBJECTS DIAGNOSED WITH STROKE:
- Other impairments secondary to stroke (e.g., attention, cognition, etc.) that would interfere with the ability to understand study goals or follow simple instructions, as judged by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
Nikitha Deepak, MS BS, 412-822-3669, nikitha.deepak@va.gov
Camona Beth, (412) 822-3700
About this study
Official title: Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms
Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which 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 modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.
Read the detailed description
Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.
- Conditions
- Paresis
- Being tested
- Transcutaneous Electrical Stimulation, Sham
- Keywords
- Learning, Neurological Rehabilitation
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical StimulationOther
Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
ShamOther
Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.
| Study group | Role | What they receive |
|---|---|---|
| Paired, Sub-Threshold Stim | Experimental | Sub-threshold stimulation paired with successful task repetitions Receives: Other: Transcutaneous Electrical Stimulation |
| Paired, Supra-Threshold Stim | Experimental | Supra-threshold stimulation paired with successful task repetition Receives: Other: Transcutaneous Electrical Stimulation |
| Unpaired, Sub-Threshold Stim | Experimental | Sub-threshold stimulation after successful task repetition Receives: Other: Transcutaneous Electrical Stimulation |
| Unpaired, Supra-Threshold Stim | Experimental | Supra-threshold stimulation after successful task repetition Receives: Other: Transcutaneous Electrical Stimulation |
| Sham | Sham comparator | No stimulation Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force Control Change
Subjects will be tested on the same task used for training that involves controlling finger forces.
Measured: Pre, 1-week Post, 1-month Post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start3 Jun 2024
- Primary completion3 Apr 2028 (estimated)
- Study completion5 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParesisStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael A. Urbin, PhD, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282406
- Sponsor's protocol ID
- N4532-R
- Other IDs
- I0X1RX004532
- Status last verified
- Apr 2026
- First submitted
- 20 Feb 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation: Motor Learning & Mechanisms
- ClinicalTrials.gov ID
- NCT06282406
- Acronym / sponsor ID
- N4532-R
- Conditions
- Paresis
- Keywords
- Learning, Neurological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 3 Apr 2028 (estimated)
- Study completion
- 5 Aug 2028 (estimated)
- First posted
- 28 Feb 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.
Vagus nerve stimulation (VNS) is thought to activate neural pathways that release chemicals which 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 modulates physiological indexes of brain states implicated in the therapeutic effects of VNS. The broad objective of this project is to better understand physiological mechanisms modulated by auricular stimulation to support possible therapeutic effects in the form of motor learning.
Detailed description
Existing evidence supports the use of VNS to enhance the effects of traditional therapy on impairments due to neurological injury. It is known that the vagus nerve forms contacts with neuromodulatory nuclei in the brainstem that release of chemicals shown to be critically involved in attentional control and memory formation. It is also known that the auricular branch of the vagus nerve innervates portions of the external ear providing a possible means to engage similar neural pathways noninvasively via transcutaneous auricular vagus nerve stimulation (taVNS). Recent work from the PI's laboratory shows that electrical current applied to landmarks on the external ear elicits transient effects on pupil dilation, an established physiological index of brain states that support learning. Given the ability to engage the biomarker, the investigators aim to further investigate physiological mechanisms modulated by taVNS and possible effects on learning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Subjects will be randomized into one of 5 groups and receive the designated stimulation/sham during a training protocol designed to facilitate motor learning.
| Arm | Type | Receives |
|---|---|---|
| Paired, Sub-Threshold Stim | Experimental | Other: Transcutaneous Electrical StimulationSub-threshold stimulation paired with successful task repetitions |
| Paired, Supra-Threshold Stim | Experimental | Other: Transcutaneous Electrical StimulationSupra-threshold stimulation paired with successful task repetition |
| Unpaired, Sub-Threshold Stim | Experimental | Other: Transcutaneous Electrical StimulationSub-threshold stimulation after successful task repetition |
| Unpaired, Supra-Threshold Stim | Experimental | Other: Transcutaneous Electrical StimulationSupra-threshold stimulation after successful task repetition |
| Sham | Sham comparator | Other: ShamNo stimulation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years of age
- Diagnosis of a single stroke resulting in hand impairment
- Diagnosis of stroke at least six months prior to the time of participation
Key exclusion criteria (12 listed)
- History of vestibular disorders or dizziness
- Difficulty maintaining alertness and/or remaining still
- Pregnant or expecting to become pregnant
- Diagnosis of neurological and/or musculoskeletal disorder(s) (other than stroke) that affect movement
- Ocular disease and/or impairment in more than one eye
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 Electrical StimulationElectrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation. | Other | Paired, Sub-Threshold Stim, Paired, Supra-Threshold Stim, Unpaired, Sub-Threshold Stim, Unpaired, Supra-Threshold Stim |
| ShamElectrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered. | Other | Sham |
Primary outcome
Force Control Change
Time frame: Pre, 1-week Post, 1-month Post
Subjects will be tested on the same task used for training that involves controlling finger forces.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Michael A. Urbin, PhD principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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 Electrical Stimulation in people with Paresis, run by VA Office of Research and Development 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael A Urbin, PhD ((412) 688-6000, Michael.Urbin@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force Control Change (time frame: Pre, 1-week Post, 1-month Post). 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 24 Apr 2026.