New Options Emerge for Treating Psych Disorders

by James Cavuoto, editor

March 2019 issue

The neurotech market for treating psychiatric disorders has expanded considerably in recent years and there are a number of new indications on the horizon. Several new alternatives for implanted, noninvasive, and diagnostic devices have emerged just in the last few months.

The effort to develop a DBS therapy for major depression continues despite the trial failures six years ago. In the wake of UCSF’s 2018 report of DBS of the lateral orbitofrontal cortex [NBR Nov18 p1], a team from the University of Freiburg in Germany earlier this month reported positive results from a trial of 16 patients with severe treatment-resistant depression using DBS of the medial forebrain bundle. Writing in the journal Neuropsychopharmacology, the investigators reported a significant reduction of MADRS ratings of depression severity in all patients—reduced by half on average. For half of the study participants depression score was reduced below the level regarded as the threshold for a depression requiring treatment. Most of the patients experienced those positive stimulation effects within the first week, and they lasted throughout the course of the one-year study.

“The most compelling outcome from the study is the sustained efficacy in very severely ill patients. We demonstrated in a relatively large-scale study that DBS is a real option for those patients suffering from treatment-resistant, severe depression,” said group leader Thomas Schläpfer, head of the division of interventional biological psychiatry at Freiburg.

The 16 participants in the FORSEE-II study had suffered from severe depression for 8 to 22 years and had previously undergone an average of 18 drug therapies, 20 ECT therapies, and 70 hours of psychotherapy without success. Volker Coenen, first author of the study and director of the stereotactic and functional neurosurgery unit at Freiburg, and his team implanted the DBS systems in the patients’ medial forebrain bundle. This brain region is involved in the perception and regulation of pleasure and reward and is thus also significant for motivation and the perceived quality of life.

On the basis of the results of the just-published study, the Freiburg researchers already began work on their third study in October 2018. It involves the treatment of 50 severely depressed patients. Fifteen patients have already been operated. “If the follow-up study is as successful as the current one, we have high hopes for receiving European approval,” said Schläpfer.

Also this month, investigators affiliated with NeuroSigma reported positive results from a sham-controlled study of 62 children with ADHD using trigeminal nerve stimulation. NeuroSigma’s Monarch external TNS therapy received CE Mark approval for ADHD in 2015 and is also approved for TRD in Europe and Canada. The company is also developing an implanted version of the therapy.

Writing in the Journal of the American Academy of Child and Adolescent Psychiatry, James McGough, from the Semel Institute at UCLA and colleagues reported that patients in the active group saw benefits in the first week of treatment and continued improvement subsequently relative to the sham group. “I am excited that we found significant reductions in ADHD symptoms, as well as associated improvements in brain functioning, as a result of TNS therapy,” said McGough. “Treatment was well accepted by patients and families, compliance was high, and there were no clinically important side effects.”

Meanwhile, the FDA’s Neurological Devices Panel is evaluating Neuronix’ NeuroAD TMS system for the treatment of Alzheimer’s disease. The device is already approved in Israel and Europe. Another TMS vendor, Nexstim plc, reported earlier this month that its NBT system received FDA clearance for a shorter treatment protocol using theta burst stimulation for treating MDD. And the FDA this month cleared a new tACS system from an Indiana firm called Innovative Neurological Devices for treatment of anxiety, insomnia, and depression. The company’s Cervella cranial electrical stimulation system incorporates its conductive electrodes into a bluetooth-enabled headset. The device, which costs $695, will compete with the Fisher-Wallace CES system.