NCT05959031

Parameter Space of kTMP

Enrolling by Invitation
NAAges 18–75InterventionalDevice feasibility
Magnetic Tides
~200 participants
Updated 2025-05-13 on ClinicalTrials.gov
What's tested:kTMPSham kTMP

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Self-reported sensation/discomfort through questionnaire during kTMP stimulation.
Measured over Measures will be obtained 4-5 seconds after each kTMP stimulation at a specific E-field (when the visual display appears on the screen), in total 16 times throughout the kTMP stimulation trial.
+3 more outcomes measured
Healthy
1 sites across 1 states
California1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Exclusion

serious medical condition
had a seizure of any sort
epilepsy or experienced seizures
neurological disorder
head injury
stroke
had any form of brain surgery
history of migraine
metal implants in your head, excluding the mouth
pacemaker
implanted medical devices of any sort
pregnant
hearing loss or hearing impairments
jet lag
stress
substance abuse
highly stressful event over the past 24 hours
broken or abnormal skin on your scalp
  • Self-reported sensation/discomfort through questionnaire during kTMP stimulation.Measures will be obtained 4-5 seconds after each kTMP stimulation at a specific E-field (when the visual display appears on the screen), in total 16 times throughout the kTMP stimulation trial.

    As per the FDA's guidance (www.fda.gov/media/81784/download) on device feasibility studies, initiation of an early feasibility study must be justified by an appropriate benefit-risk analysis and adequate human subject protection measures. This outcome measures device feasibility in terms of device tolerability. To estimate the stimulation threshold, the investigators will use an adaptive procedure in which they sequentially increase the stimulation intensity (E-field amplitude) and register self-reports of sensation. Stimulation intensity will start from 0.01 V/m (sham) increasing 0.5 V/m at a time for 16 trials until it reaches 7.6 V/m. Participants provided three ratings using an 11-point scale (0 = not at all; 10 = extremely) in response to questions on annoyance, pain, and muscle twitching. ("How annoying was kTMP?", "How painful was kTMP?", and "If there were any muscle twitches from the kTMP, how strong were they?") A higher score means more sensation/discomfort.

  • Self-reported sensation/discomfort through questionnaire after kTMP stimulation.Measures will be obtained 1 minute after kTMP stimulation.

    As per the FDA's guidance (www.fda.gov/media/81784/download) on device feasibility studies, initiation of an early feasibility study must be justified by an appropriate benefit-risk analysis and adequate human subject protection measures. This outcome measures device feasibility in terms of device tolerability. After the kTMP stimulation, the investigators will register self-reports of sensation from the participant to see any lasting effect in terms of sensation. Participants provided three ratings using an 11-point scale (0 = not at all; 10 = extremely) in response to questions on annoyance, pain, and muscle twitching. ("How annoying was kTMP?", "How painful was kTMP?", and "If there were any muscle twitches from the kTMP, how strong were they?") A higher score means more sensation/discomfort.

  • Motor evoked potential (MEPs) amplitude recorded with electromyography (EMG) before kTMP stimulation.Measures will be obtained from 0 to 15 minutes before the stimulation.

    This outcome measures device feasibility in terms of efficacy, as MEP changes indicate changes in cortical excitability induced by kTMP. As an operational definition of cortical excitability, the investigators will measure MEPs recorded in a peripheral hand muscle through the EMG system. The threshold procedure will be first conducted using single-pulse Transcranial magnetic stimulation (TMS) to find the M1 hotspot and threshold intensity. Once the threshold is set, MEPs will be obtained using the single-pulse and paired-pulse TMS procedures. These measurements will be taken prior to the experimental intervention of kTMP to obtain a baseline measure.

  • Motor evoked potential (MEPs) amplitude recorded with EMG after kTMP stimulation.Measures will be obtained 1 hour 30 minutes after the stimulation.

    This outcome measures device feasibility in terms of efficacy, as MEP changes indicate changes in cortical excitability induced by kTMP. After the kTMP stimulation as a plasticity-inducing technique, we obtain MEPs using the single-pulse and paired-pulse TMS procedures. MEPs will be recorded in a peripheral hand muscle through the EMG system. The primary intervention of interest is the kTMP system, with various manipulations of the parameter settings.