Cervicogenic Headache, Occipital Neuralgia
Conditions
Keywords
Electrical Stimulation, Neuromodulation, Head pain, Headache, Neck pain
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.
Interventions
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).
Sponsors
SPR Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in average pain and/or reduction in pain interference. | Up to 8-weeks after Start of Therapy (SOT) | 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) | During the Lead Placement procedure (SOT) | Occurrence and type of study-related AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form. |
| 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 | Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form. |
| 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 | Analgesic medication consumption will be collected. |
Countries
United States
Outcome results
None listed