The Lancet 2007; 369:1099-1106

Treatment of medically intractable cluster headache by occipital nerve stimulation: long-term follow-up of eight patients
Brian Burns MRCP a,   Laurence Watkins FRCS b   and   Prof Peter J Goadsby MD  a c

Summary
Background
Cluster headache is a form of primary headache that features repeated attacks of excruciatingly severe headache usually occurring several times a day. Patients with chronic cluster headache have unremitting illness that necessitates daily preventive medical treatment for years. When medically intractable, the condition has previously been treatable only with cranially invasive or neurally destructive methods.

Methods
Eight patients with medically intractable chronic cluster headache were implanted in the suboccipital region with electrodes for occipital nerve stimulation. Other than the first patient, who was initially stimulated unilaterally before being stimulated bilaterally, all patients were stimulated bilaterally during treatment.

Findings
At a median follow-up of 20 months (range 6–27 months for bilateral stimulation), six of eight patients reported responses that were sufficiently meaningful for them to recommend the treatment to similarly affected patients with chronic cluster headache. Two patients noticed a substantial improvement (90% and 95%) in their attacks; three patients noticed a moderate improvement (40%, 60%, and 20–80%) and one reported mild improvement (25%). Improvements occurred in both frequency and severity of attacks. These changes took place over weeks or months, although attacks returned in days when the device malfunctioned (eg, with battery depletion). Adverse events of concern were lead migrations in one patient and battery depletion requiring replacement in four.

Interpretation
Occipital nerve stimulation in cluster headache seems to offer a safe, effective treatment option that could begin a new era of neurostimulation therapy for primary headache syndromes.

Affiliations

a. Headache Group, Institute of Neurology, National Hospital for Neurology and Neurosurgery, London WC1N 3BG, UK
b. Division of Neurosurgery, Institute of Neurology, National Hospital for Neurology and Neurosurgery, London WC1N 3BG, UK
c. Department of Neurology, University of California, San Francisco, CA, USA
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Cen Eur Neurosurg. 2011 Mar 29.

Occipital Nerve Stimulation for the Treatment of Chronic Cluster Headache - Lessons Learned from 18 Months Experience.
Mueller OM, Gaul C, Katsarava Z, Diener HC, Sure U, Gasser T.

University Hospital Essen, Neurosurgery, Essen, Germany.

Abstract
OBJECTIVE: Neuromodulation has been recognized as a valuable surgical treatment option for patients with refractory chronic cluster headache (CCH). Due to the small number of afflicted individuals, the knowledge about this specific therapy is limited. In this study, we present our experiences with bilateral occipital nerve stimulation (ONS) in patients with CCH focusing on patient selection, pre- and postoperative evaluation, surgical procedures, and outcome.

PATIENTS AND METHODS: Since December 2008, 10 patients with CCH have been treated with ONS at our department. Patients were recruited and clinically followed by a neurologist and a neurosurgeon. Baseline data records on frequency, intensity, and duration of attacks as well as the use of medication were assessed with a 30-day diary. Standardized questionnaires were used pre- and postoperatively and during the follow-up on a regular basis. Surgical procedure and stimulation parameters were standardized for all patients. Lead implantation was followed by a test period of 30 days prior to implantation of the permanent generator. Mean follow-up time was 12 months (range 3-18).

RESULTS: All patients responded to the stimulation treatment. Frequency, duration, and severity of the cluster attacks were reduced in 90% of the patients. One patient had a significant reduction of his concomitant tension headache. 70 % of the patients needed less medication during the attacks. All patients reported an improvement in their quality of life. The SF-36 showed a tendency toward objective improvement in the field of psychological comfort. As a major adverse event, one generator had to be exchanged due to a local infection. Another patient had to be reoperated due to a scar tissue formation around the thoracic connector.

CONCLUSIONS: ONS is a valuable tool in the treatment of patients with refractory CCH. According to our data, the potential side effects and complication rates of the operation are small. With a meticulous selection of patients by an interdisciplinary team, CCH can bed improve in the majority of the patients. Yet, the optimal parameters for the stimulation regarding pulse width and frequency remain unclear. For this reason, we started a prospective single-center observational trial at our center in October 2009, including patients with ONS, to identify the best stimulation parameters.

PMID: 21448856 [PubMed]
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Neurology. 2009 Jan 27;72(4):341-5.
Treatment of intractable chronic cluster headache by occipital nerve stimulation in 14 patients.

Burns B, Watkins L, Goadsby PJ.

Headache Group, Department of Neurology, University of California San Francisco, San Francisco, CA 19143-0114, USA.

BACKGROUND: Cluster headache is a primary headache involving repeated attacks of excruciatingly severe headache usually occurring several times a day. Most patients with chronic cluster headache (CCH) have an unremitting illness requiring daily preventive therapy for years. OBJECTIVE: To describe the clinical outcome of occipital nerve stimulation (ONS) for 14 patients with intractable CCH. METHODS: Fourteen patients with medically intractable CCH were implanted with bilateral electrodes in the suboccipital region for ONS and a retrospective assessment of their clinical outcome obtained. RESULTS: At a median follow-up of 17.5 months (range 4-35 months), 10 of 14 patients reported improvement and 9 of these recommend ONS. Three patients noticed a marked improvement of 90% or better (90%, 90%, and 95%), 3 a moderate improvement of 40% or better (40%, 50%, and 60%), and 4 a mild improvement of 20-30% (20%, 20%, 25%, and 30%). Improvement occurred within days to weeks for those who responded most and patients consistently reported their attacks returned within hours to days when the device was off. One patient found that ONS helped abort acute attacks. Adverse events of concern were lead migrations and battery depletion. CONCLUSION: Intractable chronic cluster headache (CCH) is a devastating, disabling condition that has traditionally been treated with cranially invasive or neurally destructive procedures. ONS offers a safe, effective option for some patients with CCH. More work is required to evaluate and understand this novel therapy.

PMID: 19171831 [PubMed]
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Ther Adv Neurol Disord. 2012 Jan;5(1):57-67.
Occipital nerve stimulation in primary headache syndromes.
Lambru G, Matharu MS.
Abstract
Chronic daily headache is a major worldwide health problem that affects 3-5% of the population and results in substantial disability. Advances in the management of headache disorders have meant that a substantial proportion of patients can be effectively treated with medical treatments. However, a significant minority of these patients are intractable to conventional medical treatments. Occipital nerve stimulation (ONS) is emerging as a promising treatment for patients with medically intractable, highly disabling chronic headache disorders, including migraine, cluster headache and other less common headache syndromes. Open-label studies have suggested that this treatment modality is effective and recent controlled trial data are also encouraging. The procedure is performed using several technical variations that have been reviewed along with the complications, which are usually minor and tolerable. The mechanism of action is poorly understood, though recent data suggest that ONS could restore the balance within the impaired central pain system through slow neuromodulatory processes in the PAIN NEUROMATRIX.

WHILE THE AVAILABLE DATA ARE VERY ENCOURAGING, THE ULTIMATE CONFIRMATION OF THE UTILITY OF A NEW THERAPEUTIC MODALITY SHOULD COME FROM CONTROLLED TRIALS BEFORE WIDESPREAD USE CAN BE ADVOCATED; MORE CONTROLLED DATA ARE STILL NEEDED TO PROPERLY ASSESS THE ROLE OF ONS IN THE MANAGEMENT OF MEDICALLY INTRACTABLE HEADACHE DISORDERS. FUTURE STUDIES ALSO NEED TO ADDRESS THE VARIABLES THAT ARE PREDICTORS OF RESPONSE, INCLUDING CLINICAL PHENOTYPES, SURGICAL TECHNIQUES AND STIMULATION PARAMETERS.

PMID:22276076[PubMed]
====================
Cen Eur Neurosurg. 2011 Mar 29. [Epub ahead of print]

Occipital Nerve Stimulation for the Treatment of Chronic Cluster Headache - Lessons Learned from 18 Months Experience.
Mueller OM, Gaul C, Katsarava Z, Diener HC, Sure U, Gasser T.

University Hospital Essen, Neurosurgery, Essen, Germany.

Abstract
OBJECTIVE: Neuromodulation has been recognized as a valuable surgical treatment option for patients with refractory chronic cluster headache (CCH). Due to the small number of afflicted individuals, the knowledge about this specific therapy is limited. In this study, we present our experiences with bilateral occipital nerve stimulation (ONS) in patients with CCH focusing on patient selection, pre- and postoperative evaluation, surgical procedures, and outcome.

PATIENTS AND METHODS: Since December 2008, 10 patients with CCH have been treated with ONS at our department. Patients were recruited and clinically followed by a neurologist and a neurosurgeon. Baseline data records on frequency, intensity, and duration of attacks as well as the use of medication were assessed with a 30-day diary. Standardized questionnaires were used pre- and postoperatively and during the follow-up on a regular basis. Surgical procedure and stimulation parameters were standardized for all patients. Lead implantation was followed by a test period of 30 days prior to implantation of the permanent generator. Mean follow-up time was 12 months (range 3-18).

RESULTS: All patients responded to the stimulation treatment. Frequency, duration, and severity of the cluster attacks were reduced in 90% of the patients. One patient had a significant reduction of his concomitant tension headache. 70 % of the patients needed less medication during the attacks. All patients reported an improvement in their quality of life. The SF-36 showed a tendency toward objective improvement in the field of psychological comfort. As a major adverse event, one generator had to be exchanged due to a local infection. Another patient had to be reoperated due to a scar tissue formation around the thoracic connector.

CONCLUSIONS: ONS is a valuable tool in the treatment of patients with refractory CCH. According to our data, the potential side effects and complication rates of the operation are small. With a meticulous selection of patients by an interdisciplinary team, CCH can bed improve in the majority of the patients. Yet, the optimal parameters for the stimulation regarding pulse width and frequency remain unclear. For this reason, we started a prospective single-center observational trial at our center in October 2009, including patients with ONS, to identify the best stimulation parameters.

© Georg Thieme Verlag KG Stuttgart · New York.
PMID: 21448856 [PubMed