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Chronic cluster headache (CCH) is a disabling primary headache, considering the severity and frequency of pain attacks. Deep brain stimulation (DBS) has been used to treat severe refractory CCH, but assessment of its efficacy has been limited to open studies. We performed a prospective crossover, double-blind, multicenter study assessing the efficacy and safety of unilateral hypothalamic DBS in 11 patients with severe refractory CCH. The randomized phase compared active and sham stimulation during 1-month periods, and was followed by a 1-year open phase. The severity of CCH was assessed by the weekly attacks frequency (primary outcome), pain intensity, sumatriptan injections, emotional impact (HAD) and quality of life (SF12). Tolerance was assessed by active surveillance of behavior, homeostatic and hormonal functions. During the randomized phase, no significant change in primary and secondary outcome measures was observed between active and sham stimulation. At the end of the open phase, 6/11 responded to the chronic stimulation (weekly frequency of attacks decrease >50%), including three pain-free patients. There were three serious adverse events, including subcutaneous infection, transient loss of consciousness and micturition syncopes. No significant change in hormonal functions or electrolytic balance was observed. Randomized phase findings of this study did not support the efficacy of DBS in refractory CCH, but open phase findings suggested long-term efficacy in more than 50% patients, confirming previous data, without high morbidity. Discrepancy between these findings justifies additional controlled studies (clinicaltrials.gov number NCT00662935).

The present study shows that 2 types of symptoms increased primarily over time: Apathy and Hyperactivity. The coexistence of such opposite symptoms over time according to our result should be taken into consideration by clinicians treating those patients.

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BackgroundPresbycusis has a direct influence on autonomy of the elderly but hearing aids lack of affordability. Moreover a recent review demonstrate that electroacoustic characteristics of OTC hearing aids were generally not suitable for the elderly people. In our study, we assessed the clinical value of a new over-the-counter (OTC) hearing aid device (TEO First®) in the elderly.MethodThis prospective monocentric open label study included patients over 60 years of age with a mild to moderate presbycusis. Patients were assessed with acceptable noise level test (ANL), pure tone (PTA) and speech (SA) audiometry in silent and noisy environment, with and without TEO First®. A Glasgow Hearing Aid Benefit Profile, acceptability and satisfaction surveys were completed after one month of using the device.ResultsThirty one patients were included. There was an improvement of hearing with TEO First® in silence (SA: +39.2 %, p < 0.01; PTA: -9.04 dB, p < 0.01) or in noise (SA +47.7 %, p < 0.01; PTA: -5.23 dB, p < 0.05). After one month of use of the device, quality of life has improved with regards to the following parameters: decrease of perceived hearing difficulties during conversation without background noise (-9.6 % p = 0.018), in conversation with several people (-16.2 % p = 0.0076), decrease of negative emotions while watching TV (-18.5 % p = 0.011), during conversation without background noise (-16.5 % p = 0.0024), during conversation in noisy background (-17.1 % p = 0.027) and during conversation with several people (-20 % p = 0.014). The acceptability of the device was low to moderate.ConclusionTEO First® is an effective OTC hearing aid that improves the patient’s quality of life.Trial registrationCurrent Controlled Trials NCT01815788