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Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) in Healthy Adults
Sponsor: Soroka University Medical Center
Summary
This study evaluates the effectiveness of an improved blinding method using rotational field transcranial magnetic stimulation (rfTMS) delivered through a multi-channel deep coil system (Brainsway, Jerusalem, Israel). Healthy volunteers receive a single session of either Active or Sham stimulation over the medial prefrontal cortex. The study assesses whether the Sham condition sufficiently masks the sensory characteristics of Active stimulation. Findings will support the optimization of blinding procedures for future deep TMS (dTMS) trials.
Official title: Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimulation (rfTMS) Delivered Through a Multi-Channel Deep Coil Stimulation System in Healthy Adults
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-09-09
Completion Date
2026-07-05
Last Updated
2026-07-16
Healthy Volunteers
Yes
Conditions
Interventions
Sham rfTMS
Participants receive a single session of Sham rfTMS matched for coil placement, auditory and tactile output but without inducing field in the brain. Stimulation parameters are identical as in Active rfTMS.
Active rfTMS
Participants receive a single session of 10 HZ high-frequence Active rfTMS delivered via a multi-channel with deep coil system over the medial prefrontal cortex. Stimulation lasts \~20 minutes and consists of 100 trains, 3 seconds each, separated by 9-seconds inter-train intervals (3000 pulses in total), delivered at 90% of individual foot motor cortex resting motor threshold.
Locations (1)
Soroke University Medical Center
Beersheba, Israel