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

N/AActive Not RecruitingNCT05491915

SPR Therapeutics, Inc.50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervicogenic Headache Occipital Neuralgia

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON) Key Exclusion Criteria: * Prior cervical or cranial occipital surgery * Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway) * Pregnant

Locations (10)

Pacific Research Institute

Santa Rosa, California, United States

MedVadis Research

Waltham, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

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.

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

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: During the Lead Placement procedure (SOT)

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 24-48 hours post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 1-week post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 2-weeks post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 3-weeks post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 4-weeks post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 5-weeks post-SOT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Center of Clinical Research

Winston-Salem, North Carolina, United States

Pain Specialists of America - South Austin - James Casey

Austin, Texas, United States

Pain Specialists of America - Cedar Park

Cedar Park, Texas, United States

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States

Pain Specialists of America - Round Rock

Round Rock, Texas, United States

Pain Specialists of America - San Marcos

San Marcos, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 6-weeks post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 7-weeks post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 8-weeks post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 3-months post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 6-months post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 9-months post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 12-months post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 18-months post-SOT

Study-Related Adverse Events (AEs)

Occurrence and type of study-related AEs

Time frame: 24-months post-SOT

Secondary Outcomes

Reduction in average pain intensity

Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form.

Time frame: 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

Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form.

Time frame: 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

Analgesic medication consumption will be collected.

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