Pupil-Indexed Noninvasive Neuromodulation

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
VA Office of Research and Development
Study ID
NCT06282406
Status
Recruiting
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Conditions

  • Paresis

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Transcutaneous Electrical Stimulation — OTHER
    Electrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
  • Sham — OTHER
    Electrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.

Study Details

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.

Key Dates

Start date
Jun 3, 2024
Status verified
Apr 2026
Primary completion
Apr 3, 2028
Completion
Aug 5, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Paired, Sub-Threshold Stim
    Sub-threshold stimulation paired with successful task repetitions
  • Experimental: Paired, Supra-Threshold Stim
    Supra-threshold stimulation paired with successful task repetition
  • Experimental: Unpaired, Sub-Threshold Stim
    Sub-threshold stimulation after successful task repetition
  • Experimental: Unpaired, Supra-Threshold Stim
    Supra-threshold stimulation after successful task repetition
  • Sham Comparator: Sham
    No stimulation

Primary Outcome Measure

Force Control Change [ Time Frame: Pre, 1-week Post, 1-month Post ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PAPittsburghPennsylvania15240
Nikitha Deepak, MS BS
[email protected]
412-822-3669
Camona Beth
(412) 822-3700
Michael A. Urbin, PhD (PRINCIPAL_INVESTIGATOR)

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