aiTBS
Accelerated intermittent Theta Burst Stimulation
Information
Repetitive Transcranial Magnetic Stimulation (rTMS) is an emerging non-invasive technique of neuromodulation. rTMS is an approved, evidence-based and safe treatment modality for major depressive disorder (MDD).
Recent studies have proposed new adaptations of TMS, one adaptation being accelerated intermittent theta-burst stimulation (aiTBS). A-proof-of concept study in 2020 found that aiTBS using the Stanford Neuromodulation Therapy (SNT) protocol in 21 patients with MDD was highly effective; response and remission rates were 90.5%. The study also indicated feasibility and tolerability. Following this pilot study, a double blind RCT in 2021 found that 85.7% of patients with MDD in the active STN protocol met response criteria and 78.6% met remission criteria over a 4-week follow-up period. These response and remission rates are much higher than observed in currently approved rTMS protocols for TRD (approximately 30%). The question arises whether aiTBS shows efficacy in other psychiatric disorders including bipolar depression (BPD) and negative symptoms of schizophrenia (NSS). Both BPD and NSS are associated with high morbidity poor long-term outcome and mortality. Highly efficacious interventions are lacking.
Therefore, the aim of this study is to investigate the feasibility, tolerability and efficacy of aiTBS in BPD and NSS patients by using a proof-of-concept study with an open-label design. Two groups will be included, namely 8 patients with BPD and 8 patients with NSS, all aged between 18 and 65 years old. Both groups will be treated according the aiTBS-5d-8s-50i protocol in which patients are treated for 5 consecutive days with 8 daily aiTBS sessions, 10 minutes of stimulation per session and a 50 minute interval in-between each session. Questionnaires (HDRS, QIDS-SR, PANSS, SANS and CDSS) will be measured daily and during follow-up (2 weeks, 1 month, 4 months) to assess response. Primary outcomes are response and remission rates based on the questionnaire scores and feasibility and tolerability measured by side-effects and drop-out rates.
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Researcher:
Daan Neuteboom
Urmi Pahladsingh
Marjan Ploegaert
Karel Scheepstra