Richard Gawel , 2025-06-25 13:04:00
Key takeaways:
- Patients used the device for 60 days, and effects persisted for 6 months.
- 71% of patients reported improved Neck Disability Index scores.
- Adverse events were not serious and primarily included skin irritation.
MINNEAPOLIS — Patients with occipital headache experienced relief with 60 days of peripheral nerve stimulation, according to data presented at the American Headache Society 67th Annual Scientific Meeting.
“Whenever I hear occipital pain when a patient sees me, my ears perk up,” Narayan R. Kissoon, MD, a consultant in the division of headache and department of neurology at the Mayo Clinic, said during his presentation. “There are a lot of things as a provider I can offer these patients that can really distinctly change their care.”
Cervicogenic headache and occipital neuralgia can lead to occipital head pain, Kissoon said, affecting between 15% and 20% of patients who have chronic headache.
Narayan R. Kissoon
“It’s a pretty large proportion of patients that you’ll see in a headache center,” he said.
Previous research has indicated challenges in using peripheral nerve stimulation for headache, such as safety and the performance of spinal cord stimulators and other systems that were not designed to treat the peripheral nerve system, Kissoon said.
“This device is a newer device,” he said. “When I was a fellow, we didn’t even have it.”
The FDA-cleared device is designed to stimulate peripheral nerves including the occipital nerves. It uses helically coiled and flexible leads that Kissoon compared to rubber bands as well as an external pulse generator that is worn on the shoulder.
“This device has been used for other and various different indications, and it’s shown pretty similar results with brief pain inventory, with pain improvements in at least 50% in the majority of patients,” he said.
These indications have included neuropathic pain, lower back pain and shoulder pain, he said, with short-term treatment providing relief for up to 1 year.
This study included 20 patients (14 female; average age, 55 years) with occipital head pain due to cervicogenic headache and/or occipital neuralgia. Previous therapies included non-opioid pain medications (95%), physical therapy (85%) and spinal manipulation (65%).
At baseline, patients had average pain and pain interference scores of 4 or higher out of 10, with an average duration of pain of 5.4 years. However, they did not have any migraine-like features. Patients used the device for 60 days.
“We’ve noticed an improvement to pain interference and pain intensity,” Kissoon said.
The researchers assessed average pain via question 5 on the Brief Inventory (Short Form) and a 7-day diary and pain interference via BFI-SF question 9.
Percentages of patients who reported a 50% or greater reduction in pain and/or pain interference included 85% (n = 20) at 2 months after the start of treatment, 83% (n = 18) at 3 months, and 82% (n = 17) at 6 months.
Specifically, reductions in average pain included 58% at 2 months and 52% at 6 months, and reductions in pain interference included 67% at 2 months and 70% at 6 months.
“Those results are persistent,” Kissoon said.
Improvements at 6 months also included 71% of patients (12/17) who reported clinically meaningful reductions in neck disability of five or more points on the Neck Disability Index and 76% (13/17) reporting improvements in Global Impression of Change.
“I think that’s a pretty important metric,” Kissoon said.
Percentages of patients who reported a five-point or greater reduction in Headache Impact Test (HIT-6) scores included 65% at 2 months, 56% at 3 months and 59% at 6 months.
Next, 13 patients will be assessed at 9 months, and eight patients will be assessed at 12 months.
“The biggest thing is in this whole new change with peripheral nerve stimulation is the safety of this device,” Kissoon said. “You’re looking at the older studies with spinal cord stimulators, you’re having serious complications.”
For example, Kissoon noted studies indicating removed devices for 20% of patients as well as infections. But in this study, he said, none of the study-related adverse events such as skin irritation, itching and discomfort from pain from stimulation, were serious, with no infections or lead fractures reported.
“That was a huge problem in prior device studies,” he said. “Really, the only issues were skin irritation at the site of the external pulse generator.”
Kissoon and his colleagues attributed the persistence of treatment effects to possible reconditioning of central sensitization, with sensory fibers selectively activated for robust and focal activation of regions of the central nervous system associated with chronic pain.
Also, they said, the excitability of second order neurons in the trigeminal cervical complex may be altered by using occipital nerve stimulation to modulate cervical afferent input.
“In conclusion, the peripheral nerve stimulation appears to have some potential at home for safe and effective treatment for sustained pain relief and occipital headache due to occipital neuralgia and cervicogenic headache,” Kissoon said.
In addition to following these patients through 12 months, Kissoon added that this research may include other primary disorders such as cluster headache.
“The results of this are really promising,” he said.
For more information:
Narayan R. Kissoon can be reached at neurology@healio.com.
