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Completed

NCT Number: NCT07706790

Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soroke University Medical Center

Beersheba, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Blinding response distribution

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Collaborators

  • Ben-Gurion University of the Negev

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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