Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) in Healthy Adults

Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimulation (rfTMS) Delivered Through a Multi-Channel Deep Coil Stimulation System in Healthy Adults

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.

Effective Sham blinding is essential for the validity of deep TMS (dTMS) clinical trials. Existing Sham methods often fail to adequately mimic the sensory experience of Active stimulation, allowing participants to infer their treatment allocation. This prospective, randomized, double-blind study examines blinding integrity using rotational field transcranial magnetic stimulation (rfTMS) implemented on a multi-channel deep coil system (Brainsway, Jerusalem, Israel). Participants receive either Active stimulation or a Sham condition matched for coil placement, auditory and tactile experience but without inducing field in the brain. Results will inform the design of future dTMS studies.

Inclusion Criteria:

• Healthy adults aged 18-65
• Hebrew or English speakers
• No neurological, psychiatric, or developmental disorders
• No contraindications for TMS
• Able to provide informed consent

Exclusion Criteria:

• History of seizure
• Metal implants in the head or neck
• Pacemakers or implanted stimulators
• Pregnancy
• Current psychoactive medication affecting seizure threshold
• Any contraindication listed in standard TMS safety guidelines