~0 spots leftby Apr 2026

Vagal Nerve Stimulation to Reduce Inflammation and Hyperadrenergia

MS
Overseen byMark S Nash, Ph.D.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Miami

Trial Summary

What is the purpose of this trial?

The purpose of this research device study is to learn more about the autonomic nervous system. This system uses nerves to send information from the brain to the rest of the body by electrical signaling and has two divisions, the sympathetic and the parasympathetic branches. It has been thought that electrical stimulation devices could be used to restore balance to the nervous system. Because most of the imbalance seems to happen due to too much sympathetic activity, the investigator plans to focus on the parasympathetic branch. Specifically, the investigator hopes to restore balance by targeting the vagus nerve, which is the main communicator of the parasympathetic branch. The study will examine whether the investigator can decrease sympathetic activity and chronic inflammation by increasing parasympathetic activity. This is a device study that will examine the use of non-invasive vagal nerve stimulation to attenuate inflammatory stress and sympathetic hyperactivity in persons with Spinal Cord Injury and Non-Disabled Controls.

Research Team

MS

Mark S Nash, Ph.D.

Principal Investigator

University of Miami

Eligibility Criteria

Inclusion Criteria

Age 18-65
Willingness to participate in the study

Treatment Details

Interventions

  • InTENsity MicroCombo (Vagal Nerve Stimulation)
Participant Groups
9Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 4: 30 HzExperimental Treatment1 Intervention
Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Participants will also receive stimulation on a subsequent session prior to urodynamic testing. Device: InTENsity MicroCombo
Group II: Group 3: 30 HzExperimental Treatment1 Intervention
Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo
Group III: Group 2: Pre-stressorExperimental Treatment1 Intervention
Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session prior to receiving experimental sympathetic induction. Device: InTENsity MicroCombo
Group IV: Group 2: Post-stressorExperimental Treatment1 Intervention
Participants will receive 10 or 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session after experimental sympathetic induction. Device: InTENsity MicroCombo
Group V: Group 1: ResponseExperimental Treatment1 Intervention
Participants will receive 10-30 hertz stimulation to the left auricular branch of the vagus nerve, delivered over the course of 1 hour. Device: InTENsity MicroCombo
Group VI: Group 1: Low HertzExperimental Treatment1 Intervention
Participants will receive 10 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo
Group VII: Group 1: High HertzExperimental Treatment1 Intervention
Participants will receive 30 hertz stimulation to the left auricular branch of the vagus nerve, delivered in one 15 minute session. Device: InTENsity MicroCombo
Group VIII: Group 1: ControlPlacebo Group1 Intervention
Participants will receive 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session. Device: InTENsity MicroCombo
Group IX: Group 2: ControlPlacebo Group1 Intervention
Participants will receive 10 or 30 hertz stimulation to a non-vagally innervated region of the left ear, delivered in one 15 minute session prior to receiving experimental sympathetic induction. Device: InTENsity MicroCombo

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials
976
Recruited
423,000+
Sylvia Daunert profile image

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh profile image

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal