BACKGROUND: The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported. METHODS:Eighteen subjects with DSM-IV major depression participated in a 2-week, parallel, double-blind, sham-controlled study of rTMS treatment. Twelve subjects then went on to receive 4 weeksactive rTMS in an open follow-up. We examined the effects of rTMS on neuropsychologic function (up to 4 weeks), auditory threshold (up to 6 weeks exposure to rTMS noise), and an electroencephalogram (after 2 weeks). Data were analyzed by repeated measures analysis. RESULTS: There were trends for improvement in neuropsychologic performance, probably due to practice effects. No mean changes in auditory threshold occurred, but two patients showed mild high-frequency hearing loss after several weeks of rTMS. Electroencephalograms in two patients, one of whom had sham stimulation, showed minor abnormality. CONCLUSIONS: No significant mean deficits were demonstrated in this cohort. Overall, rTMS for up to 4 weeks is safe, but individual results suggest caution and the need for further investigation of the safety of several weeks of rTMS.
RCT Entities:
BACKGROUND: The safety of repetitive transcranial magnetic stimulation (rTMS) has only previously been formally studied in volunteers receiving a single session of stimulation or in a small number of depressed subjects receiving a 2-week treatment course. This study examined safety issues in depressed subjects receiving up to 4 weeks of rTMS. Efficacy results from this study have been previously reported. METHODS: Eighteen subjects with DSM-IV major depression participated in a 2-week, parallel, double-blind, sham-controlled study of rTMS treatment. Twelve subjects then went on to receive 4 weeks active rTMS in an open follow-up. We examined the effects of rTMS on neuropsychologic function (up to 4 weeks), auditory threshold (up to 6 weeks exposure to rTMS noise), and an electroencephalogram (after 2 weeks). Data were analyzed by repeated measures analysis. RESULTS: There were trends for improvement in neuropsychologic performance, probably due to practice effects. No mean changes in auditory threshold occurred, but two patients showed mild high-frequency hearing loss after several weeks of rTMS. Electroencephalograms in two patients, one of whom had sham stimulation, showed minor abnormality. CONCLUSIONS: No significant mean deficits were demonstrated in this cohort. Overall, rTMS for up to 4 weeks is safe, but individual results suggest caution and the need for further investigation of the safety of several weeks of rTMS.
Authors: Tarique Perera; Mark S George; Geoffrey Grammer; Philip G Janicak; Alvaro Pascual-Leone; Theodore S Wirecki Journal: Brain Stimul Date: 2016-03-16 Impact factor: 8.955