Parameter Space of kTMP

NCT ID: NCT05959031

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Non-invasive brain stimulation (NIBS) has attracted considerable interest in the cognitive neuroscience community, providing an important basic research tool to study brain function, with emerging clinical applications to enhance function in individuals with neurological disorders.

The investigators have developed a radically new NIBS approach, one in which subthreshold modulation of neural excitability is brought about via oscillating magnetic fields at kilohertz (kHZ) frequencies. This system, referred to kTMP (kHz Transcranial Magnetic Perturbation) significantly increases the range of subthreshold E-field induction, and through modulation of the envelope of the kHz carrier frequency, can impose E-fields at physiological relevant frequencies. The investigators will conduct testing with healthy human participants to assess the tolerability and efficacy of the system in producing changes in cortical physiology.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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active kTMP

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

Group Type EXPERIMENTAL

kTMP

Intervention Type DEVICE

a new non-invasive brain stimulation tool

sham kTMP

Participants received 0.01 V/m of sham stimulation.

Group Type SHAM_COMPARATOR

Sham kTMP

Intervention Type DEVICE

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

Interventions

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kTMP

a new non-invasive brain stimulation tool

Intervention Type DEVICE

Sham kTMP

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Age 18-75

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Magnetic Tides

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Magnetic Tides

El Cerrito, California, United States

Site Status

Countries

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United States

Other Identifiers

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MagneticTides

Identifier Type: -

Identifier Source: org_study_id

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