BrainsWay (NSDQ:BWAY) said today that a study shows that deep transcranial magnetic stimulation (dTMS) plus standard medication was significantly more effective at reducing depression levels among major depressive disorder (MDD) patients than standard medication alone.
Researchers at the Psychiatric Hospital Sveti Ivan in Croatia conducted the 228-patient randomized controlled study independent of industry support. The results appear in the July 2019 issue of the Journal of Psychiatric Research.
Patients were randomized to either four weeks of dTMS or standard rTMS in conjunction with standard pharmacotherapy, or to a control group treated with pharmacotherapy alone. The primary endpoint of the study was the proportion of patients achieving remission, defined as a Hamilton Depression rating scale (HAM-D17) score of ≤ 7 after four weeks of therapy or 20 treatments.
The remission rates for both the dTMS (H1-coil) group (59.7%) and the standard TMS (figure 8-coil) group (42.7%) were significantly higher than with the control group (11.1%), the researchers found.
Other findings from the study include:
- The response rate (defined as ≥50% decrease in HAM-D17) was significantly greater with dTMS plus pharmacotherapy (66.7%) than with standard rTMS plus pharmacotherapy (44.0%) (p = .04).
- There was a trend toward improved remission rate with dTMS (59.7%) compared with standard rTMS (42.7%). Although this trend did not achieve statistical significance in the study population, it did achieve statistical significance in the subset of patients who entered the study with moderate-to-severe MDD (HAM-D17 ≥17).
- The HAM-D17 was lowered by 59% in the dTMS group, 41% in the standard rTMS group (P = 0.048), and 17% in the control group (P < 0.001 vs dTMS; P = 0.003 vs standard rTMS).
- No difference was seen in safety or tolerability between dTMS and standard rTMS.
“This is an important study because it provides the first head-to-head comparison of two different technologies that use transcranial magnetic stimulation (TMS) to treat depression,” said Dr. Markus Heilig, a professor of psychiatry at Sweden’s Linköping University and co-principal investigator on the study. “Subjects in the study demonstrated clearly higher response rates with deep TMS, which stimulates more deeply and broadly into the brain, than with figure-8 TMS.”
“We applaud the authors for completing this landmark study confirming the value of adding deep TMS therapy as a standard treatment option for patients suffering from moderate to severe depression,” added BrainsWay CEO Yaacov Michlin in a news release.
BrainsWay is currently conducting clinical trials of deep TMS in other disorders, including smoking cessation and post-traumatic stress disorder, and is planning trials for opioid addiction, fatigue in multiple sclerosis (MS) and post-stroke rehabilitation.