Transcutaneous electrical nerve stimulation of the occipital nerves as treatment for chronic cluster headache.

Background: Chronic cluster headache (CCH) is an excruciatingly painful condition that can be difficult to treat sufficiently with the available medical treatment options. The greater occipital nerves (GON) are of major interest in treating CCH, and various invasive treatment modalities, such as stimulating or blocking the nerves, have been applied. Because the terminal segment of the GON has a superficial course, the nerve is also accessible for non-invasive transcutaneous stimulation. Transcutaneous electrical nerve stimulation (TENS) has been suggested as a treatment for different chronic headaches, but evidence of the efficacy in patients with CCH is scarce. Additionally, no consensus exists on the optimal placement of the transcutaneous stimulation electrodes or the treatment usage pattern.

Methods: In this explorative open-label clinical study, 36 patients with CCH were treated with TENS of the GON for 8-12 consecutive weeks between August 2021 and October 2023 as a separate part of the study protocol for a trial on stimulation of the GON (Clinicaltrials.gov identifier: NCT05023460). After a baseline period, TENS was used primarily as a preventive treatment, stimulating for 30 min twice daily at a minimum. The primary outcome was a change in attack frequency and safety with TENS treatment. Secondary outcomes were change in attack duration and pain intensity on the numeric rating scale, abortive treatments, and the Patient Global Impression of Change (PGIC) with TENS treatment. The change in attack frequency, duration, pain intensity, and use of abortive treatment was analyzed by comparing the baseline data with 4-weekly data from TENS treatment. The study aimed to systematically investigate the effect of TENS of the GON as a preventive treatment for CCH.

Results: Weekly attack frequency decreased from a median of 15.7 (95% confidence interval [CI] 11.2-22.1) at baseline to 11.0 (95% CI 7.4-16.4) with TENS. In all, 13 of the 36 (36%) patients had a minimum 30% reduction in attack frequency. In the group of 30% responders, the number of weekly attacks decreased from 15.8 (95% CI 9.8-24.5) at baseline to 5.8 (95% CI 3.3-10.5) attacks with TENS. Five patients became entirely or nearly attack-free. For the entire cohort, attack duration and pain intensity were also significantly reduced with TENS. The use of oxygen was reduced by 42%, and triptan injections decreased by 55%. Overall, 15 (42%) patients reported a clinically important improvement with TENS treatment, rated on the PGIC scale. The 100 Hz stimulation programs were preferred over 10 Hz. No serious adverse events were registered.

Conclusion: Transcutaneous electrical nerve stimulation of the GON significantly reduced the frequency, intensity, and duration of weekly headache attacks in patients with severe CCH. Not all patients benefitted from TENS, but the treatment responders had a substantial improvement in their cluster headache. TENS treatment was well-tolerated with little or no side effects and could be a relevant supplement to conventional preventive treatment. A standard TENS apparatus is low cost, making the treatment accessible to most patients. This paper includes a detailed, comprehensive description of our clinical application of the therapy.