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SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain

Primary Purpose

Cervicogenic Headache, Occipital Neuralgia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPRINT Peripheral Nerve Stimulation (PNS) System
Sponsored by
SPR Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervicogenic Headache focused on measuring Electrical Stimulation, Neuromodulation, Head pain, Headache, Neck pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Diabetes mellitus Type I or II
  • Prior cervical or cranial occipital surgery
  • Implanted electronic device
  • Pregnant

Sites / Locations

  • Pacific Research InstituteRecruiting
  • MedVadis ResearchRecruiting
  • Mayo Clinic RochesterRecruiting
  • Center of Clinical ResearchRecruiting
  • Pain Specialists of America - South Austin - James CaseyRecruiting
  • Pain Specialists of America - Cedar ParkRecruiting
  • Institute of Precision Pain MedicineRecruiting
  • Pain Specialists of America - Round RockRecruiting
  • Pain Specialists of America - San MarcosRecruiting
  • University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peripheral Nerve Stimulation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs
Study-Related Adverse Events (AEs)
Occurrence and type of study-related AEs

Secondary Outcome Measures

Reduction in average pain intensity
Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form.
Reduction in pain interference
Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form.
Reduction in pain medication usage
Analgesic medication consumption will be collected.

Full Information

First Posted
August 4, 2022
Last Updated
October 6, 2023
Sponsor
SPR Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05491915
Brief Title
SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
Official Title
Treatment of Head Pain With the SPRINT® Peripheral Nerve Stimulation (PNS) System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
August 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPR Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache, Occipital Neuralgia
Keywords
Electrical Stimulation, Neuromodulation, Head pain, Headache, Neck pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peripheral Nerve Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SPRINT Peripheral Nerve Stimulation (PNS) System
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction in average pain and/or reduction in pain interference.
Description
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)
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
During the Lead Placement procedure (SOT)
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
24-48 hours post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
1-week post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
2-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
3-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
4-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
5-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
6-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
7-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
8-weeks post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
3-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
6-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
9-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
12-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
18-months post-SOT
Title
Study-Related Adverse Events (AEs)
Description
Occurrence and type of study-related AEs
Time Frame
24-months post-SOT
Secondary Outcome Measure Information:
Title
Reduction in average pain intensity
Description
Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form.
Time Frame
Baseline, 8-weeks after SOT
Title
Reduction in pain interference
Description
Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form.
Time Frame
Baseline, 8-weeks after SOT
Title
Reduction in pain medication usage
Description
Analgesic medication consumption will be collected.
Time Frame
Baseline, 8-weeks after SOT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON) Key Exclusion Criteria: Diabetes mellitus Type I or II Prior cervical or cranial occipital surgery Implanted electronic device Pregnant
Facility Information:
Facility Name
Pacific Research Institute
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Barnard
Phone
707-314-0506
Email
jbarnard@pacificresearchinstitute.care
First Name & Middle Initial & Last Name & Degree
Jason Pope, MD
Facility Name
MedVadis Research
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meaghan Gentile
Phone
781-895-7954
Email
gentile@medvadis.com
First Name & Middle Initial & Last Name & Degree
David DiBenedetto, MD
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard Brown
Phone
507-422-0646
Email
Brown.Richard@mayo.edu
First Name & Middle Initial & Last Name & Degree
Matthew Pingree, MD
Facility Name
Center of Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kimberly Combs
Phone
336-765-6181
Ext
195
Email
KCombs@ccrpain.com
First Name & Middle Initial & Last Name & Degree
Christopher Gilmore, MD
Facility Name
Pain Specialists of America - South Austin - James Casey
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riley Hennessey
Phone
843-494-5439
Email
Riley@researchtex.com
First Name & Middle Initial & Last Name & Degree
Genaro Gutierrez, MD
Facility Name
Pain Specialists of America - Cedar Park
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riley Hennessey
Phone
843-494-5439
Email
Riley@researchtex.com
First Name & Middle Initial & Last Name & Degree
Genaro Gutierrez, MD
Facility Name
Institute of Precision Pain Medicine
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Candace Suckey
Phone
361-910-9160
Email
candace@ippmcc.com
First Name & Middle Initial & Last Name & Degree
Mitchell Engle, MD, PhD
Facility Name
Pain Specialists of America - Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riley Hennessey
Phone
843-494-5439
Email
Riley@researchtex.com
First Name & Middle Initial & Last Name & Degree
Genaro Gutierrez, MD
Facility Name
Pain Specialists of America - San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riley Hennessey
Phone
843-494-5439
Email
Riley@researchtex.com
First Name & Middle Initial & Last Name & Degree
Genaro Gutierrez, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madelaine Littell
Phone
801-581-7985
Email
Madelaine.Littell@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Zachary McCormick, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.sprintpns.com
Description
Sponsor's Website

Learn more about this trial

SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain

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