Conflict of Interest: Dr. Cook reports relationships with the Allergan (advisory board) American Psychiatric Association (consultant), NeoSync (grant), Neuronetics (grant), NeuroSigma (advisor, stock options, Chief Medical Officer/SVP), NIH (grant, ITVA reviewer), and VA (DSMB). Dr. Leuchter reports relationships with Biomedical Systems Corporation (consultant), Brain Biomarker Analytics LLC (Chief Scientific Officer, equity), Breast Cancer Foundation (grant), Department of Defense (grant), NeoSync (consultant, stock options), Neuronetics (grant), NeuroSigma (grant), NIH (grant), and Taisho Pharmaceuticals (consultant). Ms. Abrams reports no relationships to disclose. Dr. Cook is among the inventors named on patents/patent applications filed by the Regents of the University of California that detail devices and methods for trigeminal nerve stimulation; NeuroSigma has an exclusive, worldwide license to this technology from the Regents.
Peripheral Nerve Stimulation
Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder
Version of Record online: 28 JAN 2016
© 2016 International Neuromodulation Society
Neuromodulation: Technology at the Neural Interface
Volume 19, Issue 3, pages 299–305, April 2016
How to Cite
Cook, I. A., Abrams, M. and Leuchter, A. F. (2016), Trigeminal Nerve Stimulation for Comorbid Posttraumatic Stress Disorder and Major Depressive Disorder. Neuromodulation: Technology at the Neural Interface, 19: 299–305. doi: 10.1111/ner.12399
For more information on author guidelines, an explanation of our peer review process, and conflict of interest informed consent policies, please go to http://www.wiley.com/WileyCDA/Section/id-301854.html
- Issue online: 20 APR 2016
- Version of Record online: 28 JAN 2016
- Manuscript Accepted: 28 DEC 2015
- Manuscript Revised: 27 DEC 2015
- Manuscript Received: 24 SEP 2015
- external stimulation of the trigeminal nerve;
- major depressive disorder;
- non-invasive brain stimulation;
- posttraumatic stress disorder;
- trigeminal nerve stimulation
External stimulation of the trigeminal nerve (eTNS) is an emerging neuromodulation therapy for epilepsy and depression. Preliminary studies suggest it has an excellent safety profile and is associated with significant improvements in seizures and mood. Neuroanatomical projections of the trigeminal system suggest eTNS may alter activity in structures regulating mood, anxiety, and sleep. In this proof-of-concept trial, the effects of eTNS were evaluated in adults with posttraumatic stress disorder (PTSD) and comorbid unipolar major depressive disorder (MDD) as an adjunct to pharmacotherapy for these commonly co-occurring conditions.
Materials and Methods
Twelve adults with PTSD and MDD were studied in an eight-week open outpatient trial (age 52.8 [13.7 sd], 8F:4M). Stimulation was applied to the supraorbital and supratrochlear nerves for eight hours each night as an adjunct to pharmacotherapy. Changes in symptoms were monitored using the PTSD Patient Checklist (PCL), Hamilton Depression Rating Scale (HDRS-17), Quick Inventory of Depressive Symptomatology (QIDS-C), and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
Over the eight weeks, eTNS treatment was associated with significant decreases in PCL (p = 0.003; median decrease of 15 points; effect size d 1.5), HDRS-17 (p < 0.001; 42% response rate, 25% remission; d 2.1), and QIDS-C scores (p < 0.001; d 1.8), as well as an improvement in quality of life (Q-LES-Q, p < 0.01). eTNS was well tolerated with few treatment emergent adverse events.
Significant improvements in PTSD and depression severity were achieved in the eight weeks of acute eTNS treatment. This novel approach to wearable brain stimulation may have use as an adjunct to pharmacotherapy in these disorders if efficacy and tolerability are confirmed with additional studies.