Assessment of the Efficacy of Intensive Continuous Theta Burst Stimulation over Supplementary Motor Area in Psychogenic Non-Epileptic Seizure: A Randomized Sham-Controlled Pilot Trial

Abstract

Objectives: There is a need for novel treatment strategies for psychogenic non-epileptic seizures (PNES). Thus, we aimed to evaluate the effectiveness of continuous theta burst stimulation (cTBS) over supplementary motor area (SMA) in PNES using a randomized, sham-controlled design.
Material and Methods: About 20 right-handed patients aged between 18 to 59 years were randomly allocated into active and sham groups to receive cTBS sessions (2 sessions /day, half an hour apart, 1200 pulses per day, at 80% MT) for 5 days in a week over SMA. PNES patients were evaluated on the psychogenic non-epileptic seizure scale (PNSS), dissociative experiences scale (DES-II), hospital anxiety depression scale (HADS), WHOQOL-BREF, and clinical global impression-severity (CGI-S) at baseline, after 10th rTMS session, and2-weeks post cTBS.
Results: Our study fails to show a significant effect on between group* time interaction in the frequency of PNES attacks (F = 0.011; p = 0.998), total-PSS (F = 0.429; p = 0.654), DES-II (F = 1.865; p = 0.169), CGI-S (F = 0.239; p = 0.789)in an intention to treat protocol across 3 weeks. Minimal side effects were reported and no patient discontinued the trial citing side effects.
Conclusion: We conclude that intensive SMA, cTBS in PNES is well tolerated with non-inferior clinical benefits when compared to placebo