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| ID | Type | Description | Link |
|---|---|---|---|
| MOH_2022-04-10_010730 | Other Identifier | Israeli Ministry of Health Research Ethics Board |
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| Name | Class |
|---|---|
| Ben-Gurion University of the Negev | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rotational field transcranial magnetic stimulation (rfTMS) | Active Comparator |
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| Sham rfTMS | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham rfTMS | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blinding response distribution | 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. | Immediately post-session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alona Ron Levy, PhD Candidate in Neuroscience | Ben-Gurion University of the Negev | Study Director |
| Iuly Treger, MD, Professor | Soroka University Medical Center | Principal Investigator |
| Abraham Zangen, Professor | Ben-Gurion University of the Negev | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroke University Medical Center | Beersheba | Israel |
Individual participant data will not be shared. Summary results may be published in scientific journals.
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| Active rfTMS | Device | 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. |
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