We conducted a prospective, randomized, sham-controlled, double blind, parallel group study of right or left pre-frontal rTMS in 48 subjects with medication-resistant depression. Two thousand (50x8-s trains of 5Hz) stimuli at MEP threshold were delivered each weekday for 2weeks. We employed a sham coil and simultaneous electrical stimulation of the scalp to simulate rTMS. Mean (+/-S.D.) reductions in the HAMD-24 from baseline to 3-months were not significantly different between rTMS and sham treatment groups. However, right cranial stimulation (sham or rTMS) was significantly more effective than left cranial stimulation (sham or rTMS) (P=0.012). Mean (+/-S.D.) reductions in the HAMD from baseline to 3 months were: left: 28.1 (+/-5.36) to 19.2 (+/-11.2); and right 27.2 (+/-4.2) to 11.5 (+/-9.4). Left rTMS achieved a reduction in HAMD 9.5 points greater than that achieved by left sham, a benefit greater than that reported in a recent multi-center Phase III trial of rTMS (O'Reardon et al., 2007), albeit not statistically significant. These results suggest that somatosensory stimuli that repeatedly engage the left hemisphere may be important to the achievement of therapeutic effect.
Trial registration: ClinicalTrials.gov NCT00711568.