NCT05491915

Brief Summary

The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the top of the neck. This study will use a device called the SPRINT® PNS System. PNS stands for peripheral nerve stimulation (PNS). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
15mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Oct 2022Aug 2027

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

October 24, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

4.8 years

First QC Date

August 4, 2022

Last Update Submit

December 11, 2025

Conditions

Cervicogenic HeadacheOccipital Neuralgia

Keywords

Electrical StimulationNeuromodulationHead painHeadacheNeck pain

Outcome Measures

Primary Outcomes (17)

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

    Average pain is measured using question 5 from the Brief Pain Inventory-Short Form (BPI-5) and pain interference is measured using question 9 from the Brief Pain Inventory-Short Form (BPI-9). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. BPI-9 is a scale of 0 to 10 where 0 represents no interference and 10 represents complete interference.

    Up to 8-weeks after Start of Therapy (SOT)

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    During the Lead Placement procedure (SOT)

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    24-48 hours post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    1-week post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    2-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    3-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    4-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    5-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    6-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    7-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    8-weeks post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    3-months post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    6-months post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    9-months post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    12-months post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    18-months post-SOT

  • Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    24-months post-SOT

Secondary Outcomes (3)

  • Reduction in average pain intensity

    Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

  • Reduction in pain interference

    Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

  • Reduction in pain medication usage

    Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

Study Arms (1)

Peripheral Nerve Stimulation

EXPERIMENTAL

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.

Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Interventions

SPRINT Peripheral Nerve Stimulation (PNS) SystemDEVICE

The SPRINT System delivers mild electrical stimulation to the occipital nerves. The SPRINT System includes up to two leads (small wires) that are placed through your skin at the top of your neck. The leads attach to devices worn on your body that deliver stimulation (called Stimulators).

Peripheral Nerve Stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prior cervical or cranial occipital surgery
  • Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway)
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Pacific Research Institute

Santa Rosa, California, 95403, United States

Location

MedVadis Research

Waltham, Massachusetts, 02451, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Center of Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Pain Specialists of America - South Austin - James Casey

Austin, Texas, 78745, United States

Location

Pain Specialists of America - Cedar Park

Cedar Park, Texas, 78613, United States

Location

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

Location

Pain Specialists of America - Round Rock

Round Rock, Texas, 78681, United States

Location

Pain Specialists of America - San Marcos

San Marcos, Texas, 78666, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Links

MeSH Terms

Conditions

Post-Traumatic HeadacheHeadacheNeck Pain

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

October 24, 2022

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(10)