Pupil-Indexed Noninvasive Neuromodulation
ConditionParesis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Electrical Stimulation
Other interventionElectrical pulse trains applied to the skin overlying putative sites of auricular vagal innervation.
Sham
Other interventionElectrodes placed on the skin overlying putative sites of auricular vagal innervation but no current administered.
Treatment groups
110 Participants
are divided into 5 treatment groupsGroup A: Paired, Sub-Threshold StimExperimental treatment 1 intervention
Group B: Paired, Supra-Threshold StimExperimental treatment 1 intervention
Group C: Unpaired, Sub-Threshold StimExperimental treatment 1 intervention
Group D: Unpaired, Supra-Threshold StimExperimental treatment 1 intervention
Group E: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Force Control Change
Subjects will be tested on the same task used for training that involves controlling finger forces.
Time frame
Pre, 1-week Post, 1-month PostSponsors and contacts
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Source ClinicalTrials.gov