Condition: Treatment Resistant Depression · Sponsor: Amsterdam UMC, location VUmc
INTRODUCTION Recent findings from three small studies (total n=59) suggest that three changes in repetitive Transcranial Magnetic Stimulation (rTMS) protocols, called the Stanford Neuromodulation Therapy (SNT) protocol, contribute to extreme high overall remission of 79% in patients with treatment resistant depression (TRD), whereas remission using a standard 10 Hz rTMS protocol is 25%. The improvement using the SNT protocol is achieved by combining 1) accelerated treatment with multiple sessions per day, 2) applying a higher overall pulse dose of stimulation, using intermittent Theta Burst Stimulation (iTBS), and 3) precise targeting of the region in the left dorsolateral prefrontal cortex (DLPFC), using functional MRI guided neuronavigation. OBJECTIVE To determine if the SNT protocol is more (cost-) effective compared to standard 10 Hz rTMS in patients with TRD, even though the number of pulses given in both protocols is equal, i.e., 90,000. STUDY DESIGN Multicenter randomized controlled trial comparing SNT with standard 10Hz rTMS with a follow-up of 25 weeks. STUDY POPULATION 108 Patients with TRD (no response to 2 or more evidence-based treatments). INTERVENTION 50 sessions using the SNT protocol in 5 days. The region of the left DLPFC most anticorrelated with the subgenual anterior cingulate cortex in each participant will be targeted based on subject-specific functional resting state MRI. COMPARISON 30 standard daily 10 Hz rTMS sessions in six weeks, targeting the …
This description comes directly from the study's public registry record.
Annemiek Dols, MD PhD · 0610445878 · a.dols@amsterdamumc.nl
Eric van Exel, MD PhD · +31204444444 · e.vexel@amsterdamumc.nl
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| Radboud UMC | Nijmegen, GL, Netherlands | Recruiting |
| GGZinGeest | Amsterdam, North Holland, Netherlands | Recruiting |
| Amsterdam UMC location AMC | Amsterdam-Zuidoost, North Holland, Netherlands | Recruiting |
| Maastricht UMC | Maastricht, Netherlands | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT05900271