Nerve Stimulation Therapy for Stress

Overseen By Kimi Harada

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Spark Biomedical, Inc.

Disqualifiers: Epileptic seizures, Neurologic diseases, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new nerve stimulation therapy to help first responders manage stress. The therapy uses a device called Sparrow Link to stimulate specific nerves near the ear, potentially improving mood, reducing stress, and combating fatigue and burnout. Participants will use the therapy daily for 28 days and complete questionnaires about their stress, sleep, and overall well-being. The trial seeks first responders who feel stressed and have internet access to complete surveys. As an unphased trial, it offers first responders a unique opportunity to explore innovative stress management techniques.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that this nerve stimulation therapy is safe for first responders?

Research has shown that transcutaneous auricular neurostimulation (tAN) is generally safe for people. In earlier studies, participants using tAN experienced no serious side effects, with only a few minor issues reported. Another study found that tAN effectively reduces symptoms of opioid withdrawal, leading to FDA approval for a similar device. This suggests that tAN is well-tolerated and safe for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for stress that often involve medication or therapy sessions, Sparrow Link is a non-invasive nerve stimulation therapy. It uses transcutaneous auricular nerve stimulation (tAN), allowing individuals to self-administer the treatment daily, potentially increasing convenience and adherence. Researchers are particularly excited about its unique mechanism of action, which targets specific nerves to help manage stress levels directly, offering a promising alternative to conventional methods.

What evidence suggests that this nerve stimulation therapy is effective for stress?

Research has shown that transcutaneous auricular neurostimulation (tAN) is a promising treatment, particularly for managing opioid withdrawal symptoms. Studies have found that tAN can reduce these symptoms by up to 74.7% in just a few days. This treatment stimulates nerves in the ear, helping to control stress and mood. While most research focuses on its use for opioid withdrawal, its mechanism suggests potential benefits for stress management by affecting the nervous system. In this trial, first responders will self-administer once-daily active tAN sessions to evaluate its potential for managing stress, making tAN an intriguing option for this purpose. ^{1 2 3 5 6}

Who Is on the Research Team?

Navid Khodaparast, PhD

Principal Investigator

Spark Biomedical, Inc.

Are You a Good Fit for This Trial?

The trial is for first responders experiencing mental fatigue and stress. Participants will engage in an 8-week study, using a device called Sparrow Link for transcutaneous auricular neurostimulation (tAN) therapy. They must be willing to self-administer tAN sessions daily post-shift and complete various questionnaires about their mood, stress, sleep, energy/fatigue, and burnout.

Inclusion Criteria

GAD-7 score ≥ 5

Reliable access to an internet-enabled device to complete required questionnaires

I am 18 years old or older.

Exclusion Criteria

I am not pregnant or breastfeeding.

I have hearing problems in my left ear.

Women of childbearing potential, not using adequate contraception as per the investigator's judgement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Baseline

Participants complete daily and weekly questionnaires without tAN treatment

1 week

Daily virtual assessments

Treatment

Participants self-administer daily tAN therapy sessions and complete daily and weekly questionnaires

4 weeks

Daily self-administered sessions, weekly virtual assessments

Post-Treatment

Participants continue weekly assessments without tAN treatment

4 weeks

Weekly virtual assessments

Follow-up

Participants schedule a Study Exit Interview with the Research Coordinator

1 week

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Sparrow Link

Trial Overview Sparrow Link's effectiveness in reducing mental fatigue and stress among first responders is being tested. The device administers tAN therapy targeting specific nerves related to stress response. Participants use the device daily for four weeks while providing feedback through regular questionnaires.

How Is the Trial Designed?

Group I: Active tAN Experimental Treatment 1 Intervention

First responders will self-administer once-daily active tAN sessions for 1-2 hours for 28 days. Participants will complete daily and weekly assessments to evaluate levels of stress, mood, energy/fatigue, sleep quality , and burnout. Daily assessments and tAN sessions will cease after Day 28. Participants will continue to complete weekly assessments until Day 56.

Who Is Running the Clinical Trial?

Spark Biomedical, Inc.

Lead Sponsor

Trials

14

Recruited

560+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9385243/

Delivering transcutaneous auricular neurostimulation (tAN) to ... Participants across both groups achieved an average COWS reduction up to 74.7% on Days 2–5. Conclusion. Results demonstrate tAN is a safe and ...

2. sparkbiomedical.com sparkbiomedical.com/healthcare-providers/neurological-health

A Better Way Forward in Opioid Withdrawal Management Sparrow Ascent changes the way opioid withdrawal is managed, offering a non-invasive, FDA-cleared solution that directly targets all withdrawal symptoms.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05053503

Study Details | NCT05053503 | Delivering Transcutaneous ... The primary objective of this trial is to determine whether tAN can improve relapse prevention beyond that seen with extended-release injectable naltrexone ...

4. researchgate.net researchgate.net/publication/362767883_Delivering_transcutaneous_auricular_neurostimulation_tAN_to_improve_symptoms_associated_with_opioid_withdrawal_results_from_a_prospective_clinical_trial

Delivering transcutaneous auricular neurostimulation (tAN) ... Participants across both groups achieved an average COWS reduction up to 74.7% on Days 2–5. Conclusion: Results demonstrate tAN is a safe and effective non- ...

5. sparkbiomedical.com sparkbiomedical.com/neuroscience?e2f66aff_page=4

Pioneering Transcutaneous Auricular Neurostimulation Spark Biomedical Clinical Trials. Our clinical trials focus on demonstrating the efficacy of transcutaneous auricular neurostimulation (tAN®). Through these ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000327

Accelerated Transcutaneous Auricular Vagus Nerve ... Both taVNS dosing approaches were safe and feasible in this novel setting. There were no serious adverse events, and we observed a low rate of minor adverse ...