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Percutaneous Bioelectric Current Stimulation for Chronic Cluster Headache - A Possible Transformative Approach to Cluster Headache.

ABSTRACT: Background:Cluster headache (CH) is considered to be a catastrophic disease presenting the most severe human pain condition. Available pharmacological treatments are hampered by unwanted side effects, and there is an urgent need for non-pharmacological treatment alternatives. We present a novel therapeutic approach for chronic CH, having evolved from an episodic CH, using a non-invasive percutaneous bioelectric current stimulation (PBCS), which generates static electric fields in the range of the naturally occurring electric potentials. Patients and Methods:This study employed a retrospective data analysis of 20 cases of chronic cluster headache (CCH) patients, four of those having had cluster-related surgery (SPG, ONS). All patients were treated with PBCS between 2014 and 2018. Data of these patients were analyzed with respect to frequency of CH attacks and triptan application and followed up for one (20 cases) or two (12 cases) years. Results:Four weeks after the first PBCS treatment, cluster headache attacks were reduced from 2.8 to 1.7 per day and triptan application decreased from 2.5 to 1.5 times/day. Six non-responders, 4 of which had pre-CH surgery, did not show any reaction to PBCS, while 14 responders improved within 4 weeks from 2.2 to 0.7 attacks/day and 2.0 to 0.4 triptan applications/day. A 50% or greater reduction of attack frequency was observed in 10 patients after 4 weeks and in 11 patients after 12 weeks. One year after the first treatment, 13/20 patients experienced a reduction of attack frequency of 50% or more, while remarkably 10 patients were completely free of attack. After 2 years, 8 of 12 patients experienced a reduction of attack frequency of 50% or more and 7 of those were completely symptom-free. No serious adverse effects were observed. Conclusion:PBCS is a promising transformative treatment approach for CCH patients. Drug consumption was reduced significantly, and the CCH may revert back to an episodic cluster headache with increasingly long times of remission. Responders can be clearly differentiated from non-responders. The data support the need for randomized controlled trials.

SUBMITTER: Molsberger A

PROVIDER: S-EPMC7186886 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Percutaneous Bioelectric Current Stimulation for Chronic Cluster Headache - A Possible Transformative Approach to Cluster Headache.

Molsberger Albrecht A McCaig Colin D CD

Journal of pain research 20200423

<h4>Background</h4>Cluster headache (CH) is considered to be a catastrophic disease presenting the most severe human pain condition. Available pharmacological treatments are hampered by unwanted side effects, and there is an urgent need for non-pharmacological treatment alternatives. We present a novel therapeutic approach for chronic CH, having evolved from an episodic CH, using a non-invasive percutaneous bioelectric current stimulation (PBCS), which generates static electric fields in the ran ...[more]

PMID: 32425586

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Project description:Cluster headache (CH) is a debilitating headache disorder with severe consequences for patient quality of life. On-demand neuromodulation targeting the sphenopalatine ganglion (SPG) is effective in treating the acute pain and a subgroup of patients experience a decreased frequency of CH attacks.We monitored self-reported attack frequency, headache disability, and medication intake in 33 patients with medically refractory, chronic CH (CCH) in an open label follow-up study of the original Pathway CH-1 study. Patients were followed for at least 24 months (average 750?±?34 days, range 699-847) after insertion of an SPG microstimulator. Remission periods (attack-free periods exceeding one month, per the ICHD 3 (beta) definition) occurring during the 24-month study period were characterized. Attack frequency, acute effectiveness, medication usage, and questionnaire data were collected at regular clinic visits. The time point "after remission" was defined as the first visit after the end of the remission period.Thirty percent (10/33) of enrolled patients experienced at least one period of complete attack remission. All remission periods followed the start of SPG stimulation, with the first period beginning 134?±?86 (range 21-272) days after initiation of stimulation. On average, each patient's longest remission period lasted 149?±?97 (range 62-322) days. The ability to treat acute attacks before and after remission was similar (37 %?±?25 % before, 49 %?±?32 % after; p?=?0.2188). Post-remission headache disability (HIT-6) was significantly improved versus baseline (67.7?±?6.0 before, 55.2?±?11.4 after; p?=?0.0118). Six of the 10 remission patients experienced clinical improvements in their preventive medication use. At 24 months post insertion headache disability improvements remained and patient satisfaction measures were positive in 100 % (10/10).In this population of 33 refractory CCH patients, in addition to providing the ability to treat acute attacks, neuromodulation of the SPG induced periods of remission from cluster attacks in a subset of these. Some patients experiencing remission were also able to reduce or stop their preventive medication and remissions were accompanied by an improvement in headache disability.

Project description:BackgroundCluster headache (CH) is a debilitating condition that is generally associated with substantial health care costs. Few therapies are approved for abortive or prophylactic treatment. Results from the prospective, randomised, open-label PREVA study suggested that adjunctive treatment with a novel non-invasive vagus nerve stimulation (nVNS) device led to decreased attack frequency and abortive medication use in patients with chronic CH (cCH). Herein, we evaluate whether nVNS is cost-effective compared with the current standard of care (SoC) for cCH.MethodsA pharmacoeconomic model from the German statutory health insurance perspective was developed to estimate the 1-year cost-effectiveness of nVNS + SoC (versus SoC alone) using data from PREVA. Short-term treatment response data were taken from the clinical trial; longer-term response was modelled under scenarios of response maintenance, constant rate of response loss, and diminishing rate of response loss. Health-related quality of life was estimated by modelling EQ-5D™ data from PREVA; benefits were defined as quality-adjusted life-years (QALY). Abortive medication use data from PREVA, along with costs for the nVNS device and abortive therapies (i.e. intranasal zolmitriptan, subcutaneous sumatriptan, and inhaled oxygen), were used to assess health care costs in the German setting.ResultsThe analysis resulted in mean expected yearly costs of €7096.69 for nVNS + SoC and €7511.35 for SoC alone and mean QALY of 0.607 for nVNS + SoC and 0.522 for SoC alone, suggesting that nVNS generates greater health benefits for lower overall cost. Abortive medication costs were 23 % lower with nVNS + SoC than with SoC alone. In the alternative scenarios (i.e. constant rate of response loss and diminishing rate of response loss), nVNS + SoC was more effective and cost saving than SoC alone.ConclusionsIn all scenarios modelled from a German perspective, nVNS was cost-effective compared with current SoC, which suggests that adjunctive nVNS therapy provides economic benefits in the treatment of cCH. Notably, the current analysis included only costs associated with abortive treatments. Treatment with nVNS will likely promote further economic benefit when other potential sources of cost savings (e.g. reduced frequency of clinic visits) are considered.Trial registrationClinicaltrials.gov identifier NCT01701245 , 03OCT2012.

Project description:Background/aimsBioelectric nerve stimulation (eStim) is an emerging clinical paradigm that can promote nerve regeneration after trauma, including within the context of diabetes. However, its ability to prevent the onset of diabetic peripheral neuropathy (DPN) has not yet been evaluated. Beyond the nerve itself, DPN has emerged as a potential contributor to sarcopenia and bone disease; thus, we hypothesized that eStim could serve as a strategy to simultaneously promote neural and musculoskeletal health in diabetes.MethodsTo address this question, an eStim paradigm pre-optimized to promote nerve regeneration was applied to the sciatic nerve, which directly innervates the tibia and lower limb, for 8 weeks in control and streptozotocin-induced type 1 diabetic (T1D) rats. Metabolic, gait, nerve and bone assessments were used to evaluate the progression of diabetes and the effect of sciatic nerve eStim on neuropathy and musculoskeletal disease, while also considering the effects of cuff placement and chronic eStim in otherwise healthy animals.ResultsRats with T1D exhibited increased mechanical allodynia in the hindpaw, reduced muscle mass, decreased cortical and cancellous bone volume fraction (BVF), reduced cortical bone tissue mineral density (TMD), and decreased bone marrow adiposity. Type 1 diabetes also had an independent effect on gait. Placement of the cuff electrode alone resulted in altered gait patterns and unilateral reductions in tibia length, cortical BVF, and bone marrow adiposity. Alterations in gait patterns were restored by eStim and tibial lengthening was favored unilaterally; however, eStim did not prevent T1D-induced changes in muscle, bone, marrow adiposity or mechanical sensitivity. Beyond this, chronic eStim resulted in an independent, bilateral reduction in cortical TMD.ConclusionOverall, these results provide new insight into the pathogenesis of diabetic neuroskeletal disease and its regulation by eStim. Though eStim did not prevent neural or musculoskeletal complications in T1D, our results demonstrate that clinical applications of peripheral neuromodulation ought to consider the impact of device placement and eStim on long-term skeletal health in both healthy individuals and those with metabolic disease. This includes monitoring for compounded bone loss to prevent unintended consequences including decreased bone mineral density and increased fracture risk.

Dataset Information

Percutaneous Bioelectric Current Stimulation for Chronic Cluster Headache - A Possible Transformative Approach to Cluster Headache.

Publications

Percutaneous Bioelectric Current Stimulation for Chronic Cluster Headache - A Possible Transformative Approach to Cluster Headache.

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