Parameter Space of kTMP

Part of paid clinical trials in El Cerrito, California.

Sponsor
Magnetic Tides
Study ID
NCT05959031
Status
Enrolling By Invitation

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • kTMP — DEVICE
    a new non-invasive brain stimulation tool
  • Sham kTMP — DEVICE
    a new non-invasive brain stimulation tool with sham setting selected

Study Details

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.

Key Dates

Start date
Aug 16, 2022
Status verified
May 2025
Primary completion
Jul 31, 2025
Completion
Jul 31, 2025

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: active kTMP
    Participants received 0.5 - 8 V/m of active stimulation.
  • Sham Comparator: sham kTMP
    Participants received 0.01 V/m of sham stimulation.

Primary Outcome Measure

Self-reported sensation/discomfort through questionnaire during kTMP stimulation. [ Time Frame: 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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Magnetic TidesEl CerritoCalifornia94530-

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Magnetic Tides· El Cerrito, CA

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