Parameter Space of kTMP

NCT05959031 | Enrolling By Invitation DMC

• 1 other identifier: MagneticTides
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators have recently developed a new non-invasive brain stimulation (NIBS) system, kilohertz transcranial magnetic perturbation (kTMP) that opens up a new experimental space for safely modulating neural excitability in targeted areas of the human brain. This project will characterize the broad parameter space of kTMP in terms of tolerability and efficacy in healthy individuals. Following earlier feasibility studies, we are now increasing our number of subjects in order to capture preliminary safety and effectiveness information on a near-final device.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Self-reported sensation/discomfort through questionnaire during 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. 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.

  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.

• Self-reported sensation/discomfort through questionnaire 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.

  Measures will be obtained 1 minute after kTMP stimulation.

• Motor evoked potential (MEPs) amplitude recorded with electromyography (EMG) before kTMP 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.

  Measures will be obtained from 0 to 15 minutes before the stimulation.

• Motor evoked potential (MEPs) amplitude recorded with EMG after kTMP 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.

  Measures will be obtained 1 hour 30 minutes after the stimulation.

Study Arms (2)

active kTMP

EXPERIMENTAL

Participants received 0.5 - 8 V/m of active stimulation.

Device: kTMP

sham kTMP

SHAM COMPARATOR

Participants received 0.01 V/m of sham stimulation.

Device: Sham kTMP

Interventions

kTMP DEVICE

a new non-invasive brain stimulation tool

active kTMP

Sham kTMP DEVICE

a new non-invasive brain stimulation tool with sham setting selected

sham kTMP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75

You may not qualify if:

• 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

Sponsors & Collaborators

• Magnetic Tides: lead

Study Sites (1)

Magnetic Tides

El Cerrito, California, 94530, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 25, 2023
• Study Start: August 16, 2022
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

US (1)