A Two-site Pilot Randomized 3 Day Trial of High Dose Left Prefrontal Repetitive Transcranial Magnetic Stimulation (rTMS) for Suicidal Inpatients |
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| Institution: | 1. Ralph H. Johnson VA Medical Center, Charleston, SC, USA;2. Brain Stimulation Division, Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA;3. Walter Reed National Military Medical Center, USA;4. Department of Psychiatry, University of California at San Diego (UCSD), USA;1. Department of Neurosurgery, Rambam Medical Center, B. Rappaport Faculty of Medicine, The Technion, Israel Institute of Technology, Haifa, Israel;2. Department of Psychiatry, Rambam Medical Center, B. Rappaport Faculty of Medicine, The Technion, Israel Institute of Technology, Haifa 31096, Israel;1. Department of Psychiatry and Medical Psychology, Ghent University, Ghent, Belgium;2. Ghent Experimental Psychiatry (GHEP) Lab, Ghent University, Ghent, Belgium;3. Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium;4. Department of Psychiatry, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Laarbeeklaan 101, 1090 Brussels, Belgium;1. Ghent University, Department of Psychiatry and Medical Psychology, Ghent, Belgium;2. Department of Psychiatry, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium;3. Ghent University, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium;4. Ghent University, Department of Data Analysis, Ghent, Belgium;5. Department of Nuclear Medicine, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Laarbeeklaan 101, 1090 Brussels, Belgium;6. Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China;7. iMinds Medical IT-IBiTech – MEDISIP, Department of Electronics and Information Systems, Ghent University, Ghent, Belgium;8. Ghent University, Department of Nuclear Medicine, Ghent, Belgium;9. Ghent University, Laboratory of Radiopharmacy, Faculty of Pharmaceutical Sciences, Ghent, Belgium;10. Ghent University, Department of Veterinary Medical Imaging and Small Animal Orthopaedics, Faculty of Veterinary Medicine, Merelbeke, Belgium;11. Ghent University, Department of Experimental Clinical and Health Psychology, Ghent, Belgium;1. Department of Psychiatry and Medical Psychology, Ghent University, De Pintelaan 185, 9000 Ghent, Belgium;2. University Hospital (UZBrussel), Department of Psychiatry, Brussels, Belgium;3. Ghent Experimental Psychiatry (GHEP) Lab, Ghent University, Ghent, Belgium;4. Department of Experimental Clinical and Health Psychology, Ghent University, Ghent, Belgium;1. Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan;2. Division of Psychiatry and Institute of Brain Science, School of Medicine, National Yang-Ming University, Taipei, Taiwan;3. Brain Research Center, School of Medicine, National Yang-Ming University, Taipei, Taiwan;4. Department of Psychiatry, Cheng Hsin General Hospital, Taipei, Taiwan;5. Institute of Cognitive Neuroscience, National Central University, Jhongli, Taiwan;1. Epworth Centre for Innovation in Mental Health, Epworth Healthcare, The Epworth Clinic, Camberwell, Victoria, Australia;2. Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Victoria, Australia;3. Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Ontario, Canada |
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| Abstract: | BackgroundSuicide attempts and completed suicides are common, yet there are no proven acute medication or device treatments for treating a suicidal crisis. Repeated daily left prefrontal repetitive transcranial magnetic stimulation (rTMS) for 4–6 weeks is a new FDA-approved treatment for acute depression. Some open-label rTMS studies have found rapid reductions in suicidality.DesignThis study tests whether a high dose of rTMS to suicidal inpatients is feasible and safe, and also whether this higher dosing might rapidly improve suicidal thinking. This prospective, 2-site, randomized, active sham-controlled (1:1 randomization) design incorporated 9 sessions of rTMS over 3 days as adjunctive to usual inpatient suicidality treatment. The setting was two inpatient military hospital wards (one VA, the other DOD).PatientsResearch staff screened approximately 377 inpatients, yielding 41 adults admitted for suicidal crisis. Because of the funding source, all patients also had either post-traumatic stress disorder, mild traumatic brain injury, or both.TMS methodsRepetitive TMS (rTMS) was delivered to the left prefrontal cortex with a figure-eight solid core coil at 120% motor threshold, 10 Hertz (Hz), 5 second (s) train duration, 10 s intertrain interval for 30 minutes (6000 pulses) 3 times daily for 3 days (total 9 sessions; 54,000 stimuli). Sham rTMS used a similar coil that contained a metal insert blocking the magnetic field and utilized electrodes on the scalp, which delivered a matched somatosensory sensation.Main outcome measurePrimary outcomes were the daily change in severity of suicidal thinking as measured by the Beck Scale of Suicidal Ideation (SSI) administered at baseline and then daily, as well as subjective visual analog scale measures before and after each TMS session. Mixed model repeated measures (MMRM) analysis was performed on modified intent to treat (mITT) and completer populations.ResultsThis intense schedule of rTMS with suicidal inpatients was feasible and safe. Minimal side effects occurred, none differing by arm, and the 3-day retention rate was 88%. No one died of suicide within the 6 month followup. From the mITT analyses, SSI scores declined rapidly over the 3 days for both groups (sham change ?15.3 points, active change ?15.4 points), with a trend for more rapid decline on the first day with active rTMS (sham change ?6.4 points, active ?10.7 points, P = 0.12). This decline was more pronounced in the completers subgroup sham change ?5.9 (95% CI: ?10.1, ?1.7), active ?13 points (95% CI: ?18.7, ?7.4); P = 0.054]. Subjective ratings of ‘being bothered by thoughts of suicide’ declined non-significantly more with active rTMS than with sham at the end of 9 sessions of treatment in the mITT analysis sham change ?31.9 (95% CI: ?41.7, ?22.0), active change ?42.5 (95% CI: ?53.8, ?31.2); P = 0.17]. There was a significant decrease in the completers sample sham change ?24.9 (95% CI: ?34.4, ?15.3), active change ?43.8 (95% CI: ?57.2, ?30.3); P = 0.028].ConclusionsDelivering high doses of left prefrontal rTMS over three days (54,000 stimuli) to suicidal inpatients is possible and safe, with few side effects and no worsening of suicidal thinking. The suggestions of a rapid anti-suicide effect (day 1 SSI data, Visual Analogue Scale data over the 3 days) need to be tested for replication in a larger sample.Trial registrationClinicalTrials.gov Identifier: NCT01212848, TMS for suicidal ideation. |
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| Keywords: | TMS Transcranial Suicide Prefrontal Magnetic |
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