Healthy Volunteers
Conditions
Keywords
Noninvasive Brain Stimulation, Transcranial Magnetic Stimulation (TMS), Rotational Field TMS (rfTMS), Deep Coil TMS (dTMS), Multi-Channel, Sham-Blinding, Masking Method, Ramp-Up/Down, Healthy
Brief 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.
Detailed description
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.
Interventions
DEVICESham 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.
DEVICEActive 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.
Sponsors
Soroka University Medical Center
Ben-Gurion University of the Negev
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blinding response distribution | Immediately post-session | Distribution of participant responses on a five-scale blinding questionnaire indicating perceived stimulation type (Active vs Sham), reported as the proportion of participants selecting each response category. |
Countries
Israel
Contacts
STUDY_DIRECTORAlona Ron Levy, PhD Candidate in Neuroscience
Ben-Gurion University of the Negev
PRINCIPAL_INVESTIGATORIuly Treger, MD, Professor
Soroka University Medical Center
STUDY_CHAIRAbraham Zangen, Professor
Ben-Gurion University of the Negev
Outcome results
None listed