Deep brain stimulation (DBS) has been proposed for severe, chronic, treatment-refractory obsessive-compulsive disorder (OCD) patients. Although serious adverse events can occur, only a few studies report on the safety profile of DBS for psychiatric disorders. In a prospective, open-label, interventional multi-center study, we examined the safety and efficacy of electrical stimulation in 30 patients with DBS electrodes bilaterally implanted in the anterior limb of the internal capsule. Safety, efficacy, and functionality assessments were performed at 3, 6, and 12 months post implant. An independent Clinical Events Committee classified and coded all adverse events (AEs) according to EN ISO14155:2011. All patients experienced AEs (195 in total), with the majority of these being mild (52% of all AEs) or moderate (37%). Median time to resolution was 22 days for all AEs and the etiology with the highest AE incidence was 'programming/stimulation' (in 26 patients), followed by 'New illness, injury, condition' (13 patients) and 'pre-existing condition, worsening or exacerbation' (11 patients). Sixteen patients reported a total of 36 serious AEs (eight of them in one single patient), mainly transient anxiety and affective symptoms worsening (20 SAEs). Regarding efficacy measures, Y-BOCS reduction was 42% at 12 months and the responder rate was 60%. Improvements in GAF, CGI, and EuroQol-5D index scores were also observed. In sum, although some severe AEs occurred, most AEs were mild or moderate, transient and related to programming/stimulation and tended to resolve by adjustment of stimulation. In a severely treatment-resistant population, this open-label study supports that the potential benefits outweigh the potential risks of DBS.
This pilot study indicates that CB autograft transplantation is a relatively simple, safe, and viable therapeutical approach for the treatment of patients with advanced PD. More studies are needed to optimize the procedure and to assess its general applicability for the treatment of patients with PD.
Background: According to previous studies, the quality of life is usually substantially altered in patients who have suffered a subarachnoid hemorrhage of an aneurysmal origin. Some studies have attempted to find out which factors predict the deterioration in quality of life. Our study will try to describe the quality of life of these patients and discover which variables may predict it in each of its dimensions. Methods: The participants were 70 patients with aneurysmal subarachnoid hemorrhage between 15 and 85 years of age. The instrument used to measure the quality of life is the SF-36 with its eight dimensions. The predictor variables introduced into the multiple linear regressions are neurological condition on admission [World Federation of Neurological Surgeons (WFNS) scale and Hunt and Hess scale], extension of the hemorrhage (Fisher scale), sex, age, physical handicaps, and the Glasgow Outcome Scale (GOS) on release. Results: The results showed that 42.9% of the patients had a deteriorated quality of life after 4 months, and that the most affected dimension was the Physical Role (60%). The two factors that predict quality of life are sex and physical handicaps. Other factors that intervene are the GOS on release and the WFNS. Conclusions: The patients who have experienced an aneurysmal subarachnoid hemorrhage show greater difficulty in performing daily activities, and they present more depression and anxiety. The absence of handicaps and being male are predictor factors for an unaffected quality of life.
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