Healthy VolunteersNCT07706790
Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimualtion (rfTMS) in Healthy Adults
A study testing Active rfTMS in people with Healthy Volunteers, run by Soroka University Medical Center at 1 site in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Active rfTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Sep 2025to 5 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18-65
- Hebrew or English speakers
- No neurological, psychiatric, or developmental disorders
- No contraindications for TMS
- Able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Sham rfTMS, Active rfTMS
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham rfTMSDevice
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 rfTMSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active rotational field transcranial magnetic stimulation (rfTMS) | Active comparator | Not described Receives: Device: Active rfTMS |
| Sham rfTMS | Sham comparator | Not described Receives: Device: Sham rfTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately post-session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start9 Sep 2025
- Primary completion18 Dec 2025
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, Iuly Treger MD, Soroka University Medical Center
- Investigators
- Alona Ron Levy, PhD Candidate in Neuroscience, Study director, Ben-Gurion University of the NegevIuly Treger, MD, Professor, Principal investigator, Soroka University Medical CenterAbraham Zangen, Professor, Study chair, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706790
- Sponsor's protocol ID
- 0203-21-SOR (as amendment)
- Other IDs
- MOH_2022-04-10_010730
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Summary results may be published in scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blinding Integrity Assessment Using Rotational Field Transcranial Magnetic Stimulation (rfTMS) Delivered Through a Multi-Channel Deep Coil Stimulation System in Healthy Adults
- ClinicalTrials.gov ID
- NCT07706790
- Acronym / sponsor ID
- 0203-21-SOR (as amendment)
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 18 Dec 2025 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rotational field transcranial magnetic stimulation (rfTMS) | Active comparator | Device: Active rfTMS |
| Sham rfTMS | Sham comparator | Device: Sham rfTMS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy adults aged 18-65
- Hebrew or English speakers
- No neurological, psychiatric, or developmental disorders
- No contraindications for TMS
- Able to provide informed consent
Key exclusion criteria (6 listed)
- History of seizure
- Metal implants in the head or neck
- Pacemakers or implanted stimulators
- Pregnancy
- Current psychoactive medication affecting seizure threshold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham rfTMSParticipants 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. | Device | Sham rfTMS |
| Active rfTMSParticipants 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. | Device | Active rotational field transcranial magnetic stimulation (rfTMS) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Summary results may be published in scientific journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alona Ron Levy, PhD Candidate in Neuroscience study director
Ben-Gurion University of the Negev
Iuly Treger, MD, Professor principal investigator
Soroka University Medical Center
Abraham Zangen, Professor study chair
Ben-Gurion University of the Negev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active rfTMS in people with Healthy Volunteers, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinding response distribution (time frame: Immediately post-session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.