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Neuromodulation

Neuromodulation Therapy for Heart Failure

Q: Does this research currently have any openings for participants?

Indeed, clinicaltrials.gov shows that this research is recruiting participants; it was published on May 1st 2022 and updated in the 11th of that same month. The study requires 158 individuals from a single medical center to join.

Q: Does this clinical trial accept applicants above the age of eighty?

To be considered for this clinical trial, applicants must fall within the bracket of 18 to 85. For those outside these age parameters, there are 50 trials available for minors and 969 specifically designed for elderly adults.

Q: How many participants are currently participating in this clinical trial?

Affirmative. Clinicaltrials.gov has evidence indicating that this trial is actively recruiting participants, with the original post made on May 1st 2022 and the most recent update occurring on May 11th 2022. Currently, 158 individuals are sought from a single site.

Q: Who satisfies the eligibility criteria for participating in this research project?

This clinical trial seeks 158 patients who are between 18 and 85 years old, suffering from inflammation. The criteria for eligibility is that simple.

N/A

Recruiting

Led By Tarun Dasari, MD, MPH

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Systolic heart failure with EF < or equal to 50%.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in inflammatory markers after 12 weeks compared to baseline

Awards & highlights

Study Summary

This trial is testing the effects of low level transcutaneous electrical stimulation of the vagus nerve at the tragus (LLTS) on heart failure symptoms, exercise capacity and quality of life in patients with HFrEF, and simultaneously determine the impact of LLTS on the suppression of inflammation and improvement in endothelial function.

Who is the study for?

This trial is for adults with heart failure where the heart's pumping ability is reduced (EF ≤ 50%). It's not suitable for pregnant individuals, those with severe liver disease, recent heart attacks or unstable angina, active cancer, certain nerve surgeries (vagotomy), frequent fainting due to low blood pressure, specific irregular heartbeat conditions without a pacemaker, or dangerously low blood pressure from autonomic dysfunction.Check my eligibility

What is being tested?

The study tests if a neuromodulation device that stimulates the vagus nerve can improve symptoms and quality of life in patients with heart failure. Participants will use this device for an hour daily over three months and compare it against a sham (fake) treatment to measure effects on exercise capacity, inflammation levels and endothelial function.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort at the stimulation site, headache, voice changes due to nerve stimulation or skin irritation. More serious but rare risks might involve changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My heart's pumping ability is reduced (EF ≤ 50%).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in 6mwd after 12 weeks compared to baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in 6mwd after 12 weeks compared to baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in 6mwd after 12 weeks compared to baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

6MWD

Secondary outcome measures

QoL

Other outcome measures

FMD

HRV

Inflammation

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ExperimentalExperimental Treatment1 Intervention

Active LLTS will be performed by use of a neuromodulation device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 12 weeks.

Group II: Control armPlacebo Group1 Intervention

Sham LLTS will be performed by use of a neuromodulation device with electrodes attached to the ear lobule. Stimulator will be applied continuously for 1 hour daily for 12 weeks.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,674 Previous Clinical Trials

28,020,747 Total Patients Enrolled

42 Trials studying Heart Failure

213,157 Patients Enrolled for Heart Failure

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,767 Total Patients Enrolled

4 Trials studying Heart Failure

209 Patients Enrolled for Heart Failure

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,718 Total Patients Enrolled

35 Trials studying Heart Failure

7,728 Patients Enrolled for Heart Failure

Media Library

Tragus Stimulator (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT05230732 — N/A

Heart Failure Research Study Groups: Experimental, Control arm

Heart Failure Clinical Trial 2023: Tragus Stimulator Highlights & Side Effects. Trial Name: NCT05230732 — N/A

Tragus Stimulator (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230732 — N/A

Frequently Asked Questions

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

Does this research currently have any openings for participants?

"Indeed, clinicaltrials.gov shows that this research is recruiting participants; it was published on May 1st 2022 and updated in the 11th of that same month. The study requires 158 individuals from a single medical center to join."

Answered by AI

Does this clinical trial accept applicants above the age of eighty?

"To be considered for this clinical trial, applicants must fall within the bracket of 18 to 85. For those outside these age parameters, there are 50 trials available for minors and 969 specifically designed for elderly adults."

Answered by AI

How many participants are currently participating in this clinical trial?

"Affirmative. Clinicaltrials.gov has evidence indicating that this trial is actively recruiting participants, with the original post made on May 1st 2022 and the most recent update occurring on May 11th 2022. Currently, 158 individuals are sought from a single site."

Answered by AI

Who satisfies the eligibility criteria for participating in this research project?

"This clinical trial seeks 158 patients who are between 18 and 85 years old, suffering from inflammation. The criteria for eligibility is that simple."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Neuromodulation of Inflammation and Endothelial Function

2022. "Neuromodulation of Inflammation and Endothelial Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05230732.