← Back to Search

Other

Peripheral Nerve Stimulation for Headache

N/A

Recruiting

Research Sponsored by SPR Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON)

Key

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot

Awards & highlights

Study Summary

This trial will test whether electrical stimulation of the nerves at the top of the neck can relieve pain.

Who is the study for?

This trial is for individuals with specific head pain conditions like cervicogenic headache or occipital neuralgia. It's not suitable for those with uncontrolled diabetes, pregnant women, people who've had prior neck or back-of-the-head surgery, or those with certain implanted electronic devices.Check my eligibility

What is being tested?

The study tests the SPRINT Peripheral Nerve Stimulation System to see if it can relieve head pain by delivering electrical stimulation to nerves in the upper neck. The device is FDA-cleared for up to 60 days of use for chronic or acute pain relief.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, skin irritation from adhesive pads, and possible nerve injury due to electrical stimulation. However, individual experiences may vary.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with cervicogenic headache or occipital neuralgia.

Select...

It seems like there might be some information missing from your request. Can you provide more details or context so I can assist you better?

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8-weeks after sot, 3-months after sot, 6-months after sot, 9-months after sot, 12-months after sot for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Reduction in average pain and/or reduction in pain interference.

Study-Related Adverse Events (AEs)

Secondary outcome measures

Reduction in average pain intensity

Reduction in pain interference

Reduction in pain medication usage

Trial Design

1Treatment groups

Experimental Treatment

Group I: Peripheral Nerve StimulationExperimental Treatment1 Intervention

All study subjects will have up to 2 leads placed in the back of their neck, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SPRINT Peripheral Nerve Stimulation (PNS) System

2017

N/A

~220

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SPR Therapeutics, Inc.Lead Sponsor

11 Previous Clinical Trials

725 Total Patients Enrolled

Media Library

SPRINT Peripheral Nerve Stimulation (PNS) System (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05491915 — N/A

Cervicogenic Headache Research Study Groups: Peripheral Nerve Stimulation

Cervicogenic Headache Clinical Trial 2023: SPRINT Peripheral Nerve Stimulation (PNS) System Highlights & Side Effects. Trial Name: NCT05491915 — N/A

SPRINT Peripheral Nerve Stimulation (PNS) System (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05491915 — N/A

Cervicogenic Headache Patient Testimony for trial: Trial Name: NCT05491915 — N/A

Frequently Asked Questions

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

How many individuals are included in the current clinical trial?

"Affirmative, the clinicaltrials.gov database denotes that this research is actively seeking participants. It was posted on October 24th 2022 and has since been ammended November 22nd 2022. The trial necessitates 50 patients across two facilities."

Answered by AI

Are there any openings still available for this research endeavor?

"Clinicaltrials.gov attests that this trial is actively seeking enrolment, having been first posted on October 24th 2022 and updated as recently as November 22nd 2022."

Answered by AI

Who else is applying?

What state do they live in?

North Carolina

New Jersey

Other

Texas

What site did they apply to?

Center of Clinical Research

Pain Specialists of America - Round Rock

Pacific Research Institute

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have gotten Botox to help for a year and an half and have tried countless medications for over 2 years. My doctor said I could possibly be a good candidate.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain

2022. "The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05491915.

All > Nerve Pain