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Behavioural Intervention

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation (OMT_taVNS Trial)

N/A
Recruiting
Led By Harald M Stauss, MD, PhD
Research Sponsored by Burrell College of Osteopathic Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 110 minutes
Awards & highlights

OMT_taVNS Trial Summary

This trial will evaluate the hypothesis that osteopathic manipulative treatment (OMT) and non-invasive transcutaneous auricular vagus nerve stimulation (taVNS) can help to reduce inflammation by activating the nervous system.

OMT_taVNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~110 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 110 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of the Interventions on Inflammation
Secondary outcome measures
Change in Autonomic Nervous System Function Induced by the Interventions
Cumulative Effect of the Interventions on Autonomic Nervous System Function

OMT_taVNS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Experimental Treatment4 Interventions
In 4 randomized study sessions, combinations of non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), osteopathic splenic lymphatic pump technique (SpLPT) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of taVNS, SpLPT, or sham interventions will be performed.
Group II: Osteopathic Manipulative Treatment (OMT)Experimental Treatment4 Interventions
In 4 randomized study sessions, combinations of two different osteopathic manipulative treatment (OMT) techniques (occipito-atlantal decompression [OA DC] and splenic lymphatic pump technique [SpLPT]) or their respective sham interventions will be performed. The 4 study sessions are at least one month apart and consist of 3 consecutive study days on which the same combination of OMT techniques or sham interventions will be performed.
Group III: Time ControlActive Control1 Intervention
In 4 study sessions, no intervention will be performed. As with the two experimental arms, the 4 study sessions are at least one month apart and consist of 3 consecutive study days on which no intervention will be performed. This arm serves as a time control group.

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Who is running the clinical trial?

Burrell College of Osteopathic MedicineLead Sponsor
4 Previous Clinical Trials
260 Total Patients Enrolled
Harald M Stauss, MD, PhDPrincipal InvestigatorBurrell College of Osteopathic Medicine
3 Previous Clinical Trials
110 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for this research project?

"The data available on clinicaltrials.gov confirms that this research has opened its recruitment program and is actively looking for participants. The trial was posted on June 1st 2020, with the most recent update taking place in January 28th 2022."

Answered by AI

How many participants are slated to take part in this research study?

"Yes, according to clinicaltrials.gov's records, recruitment for this medical experiment is currently ongoing; the study was initially posted on June 1st 2020 and last modified on January 28th 2022. A total of 36 patients need to be enrolled from a single site."

Answered by AI
~7 spots leftby Mar 2025