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NCT05491915 · ClinicalTrials.gov registry record · NA
The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
A NA study of Cervicogenic Headache and Occipital Neuralgia, sponsored by SPR Therapeutics.
- Active
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 10
- Study locations
NCT05491915: Active NA study of Cervicogenic Headache and Occipital Neuralgia, sponsored by SPR Therapeutics.
NCT05491915 is a NA study of Cervicogenic Headache and Occipital Neuralgia that is active but no longer recruiting, run by SPR Therapeutics. The registered enrollment target is 50 participants, below the 58-participant average among 4 other Cervicogenic Headache trials with a reported enrollment target (14% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05491915, a NA study of Cervicogenic Headache and Occipital Neuralgia, is active but no longer recruiting, sponsored by SPR Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE SPRINT Peripheral Nerve Stimulation (PNS) System
Study Locations (10)
Texas
- Pain Specialists of America - South Austin - James Casey - Austin
- Pain Specialists of America - Cedar Park - Cedar Park
- Institute of Precision Pain Medicine - Corpus Christi
- Pain Specialists of America - Round Rock - Round Rock
- Pain Specialists of America - San Marcos - San Marcos
California
- Pacific Research Institute - Santa Rosa
Massachusetts
- MedVadis Research - Waltham
Minnesota
- Mayo Clinic Rochester - Rochester
North Carolina
- Center of Clinical Research - Winston-Salem
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-10-24 |
| Est. Completion | 2027-08 |
| Phase | NA |
What the registry record for NCT05491915 still lists
NCT05491915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 58-participant average among 4 other Cervicogenic Headache trials with a reported enrollment target (14% lower).
The record links to 2 conditions, with Cervicogenic Headache appearing as the primary indexed condition, and to 1 intervention - of which SPRINT Peripheral Nerve Stimulation (PNS) System is the first listed.
NCT05491915 lists 10 locations in 6 states (Texas, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05491915 about?
NCT05491915 is a clinical study titled "The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain". 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 ...
What is the current status of trial NCT05491915?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-10-24. Estimated completion is 2027-08.
What conditions does trial NCT05491915 study?
This clinical trial studies the following conditions: Cervicogenic Headache, Occipital Neuralgia.
What interventions are being tested in trial NCT05491915?
The interventions under investigation include: SPRINT Peripheral Nerve Stimulation (PNS) System (DEVICE).
Who is sponsoring clinical trial NCT05491915?
This trial is sponsored by SPR Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05491915 being conducted?
This trial has 10 study locations across California, Massachusetts, Minnesota, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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