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

NCT07706790 | Completed

• 2 other identifiers: 0203-21-SOR (as amendment)MOH_2022-04-10_010730
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Active rotational field transcranial magnetic stimulation (rfTMS)

ACTIVE COMPARATOR

Device: Active rfTMS

Sham rfTMS

SHAM COMPARATOR

Device: Sham rfTMS

Interventions

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.

Sham 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.

Active rotational field transcranial magnetic stimulation (rfTMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Soroka University Medical Center: lead
• Ben-Gurion University of the Negev: collaborator

Study Sites (1)

Soroke University Medical Center

Beersheba, Israel

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rehabilitation Department

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 16, 2026
• Study Start: September 9, 2025
• Primary Completion: December 18, 2025
• Study Completion: July 5, 2026
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)