Real-world efficacy of deep TMS for obsessive-compulsive disorder: Post-marketing data collected from twenty-two clinical sites.

BACKGROUND: Deep transcranial magnetic stimulation (dTMS) with the H7-coil was FDA cleared for obsessive-compulsive disorder (OCD) in August 2018 based on multicenter sham-controlled studies. Here we look at the efficacy of dTMS for OCD in real world practices. METHODS: All dTMS clinics were asked to supply their data on treatment details and outcome measures. The primary outcome measure was response, defined by at least a 30% reduction in the Yale Brown Obsessive Compulsive Scale (YBOCS) score from baseline to endpoint. Secondary outcome measures included first response, defined as the first time the YBOCS score has met response criteria, and at least one-month sustained response. Analyses included response rate at the endpoint (after 29 dTMS sessions), number of sessions and days required to reach first response and sustained response. RESULTS: Twenty-two clinical sites with H7-coils provided data on details of treatment and outcome (YBOCS) measures from a total of 219 patients. One-hundred-sixty-seven patients who had at least one post-baseline YBOCS measure were included in the main analyses. Overall first and sustained response rates were 72.6% and 52.4%, respectively. The response rate was 57.9% in patients who had YBOCS scores after 29 dTMS sessions. First response was achieved in average after 18.5 sessions (SD = 9.4) or 31.6 days (SD = 25.2). Onset of sustained one-month response was achieved in average after 20 sessions (SD = 9.8) or 32.1 days (SD = 20.5). Average YBOCS scores demonstrated continuous reduction with increasing numbers of dTMS sessions. CONCLUSIONS: In real-world clinical practice, the majority of OCD patients benefitted from dTMS, and the onset of improvement usually occurs within 20 sessions. Extending the treatment course beyond 29 sessions results in continued reduction of OCD symptoms, raising the prospect of value for extended treatment protocols in non-responders.

The utility of bone cement to prevent lead migration with minimally invasive placement of spinal cord stimulator laminectomy leads.

BACKGROUND: Lead migration is a significant concern with spinal cord stimulator (SCS) placement with rates ranging from 10% to 60%. OBJECTIVE: To describe a novel technique using bone cement at the laminotomy site to help prevent lead migration after minimally invasive placement of laminectomy paddle leads and to present our short-term results. METHODS: A review of a prospectively maintained database identified all patients who underwent minimally invasive placement of laminectomy leads with the use of bone cement. All procedures were performed between July 2008 and August 2010 with conscious sedation and local anesthetic. Intraoperative testing was performed to confirm good pain coverage. A small volume of bone cement (1-3 cm) was then placed to cover the laminectomy defect. Radiographic and clinical follow-up was assessed. RESULTS: Forty-two patients (mean age, 58.0 years) underwent 42 procedures. Back pain (88.1%) and leg pain (88.6%) were the most common presenting symptoms. No intraoperative complications were noted. Two patients (4.8%) required removal of their devices because of nonhealing wounds. All patients were followed up for a minimum of 6 months, and no cases of clinical or radiographic lead migration were seen at the time of publication. CONCLUSION: We present a novel technique in the hopes of decreasing the incidence of lead migration after minimally invasive placement of spinal cord stimulator laminectomy paddle leads. Our results have been promising thus far with no cases of lead migration.