Parameter Space of kTMP (SBIR_2022)

Magnetic Tides

Status: Invitation-only

Conditions: Healthy

Treatments: Device: Sham kTMP; Device: kTMP

Study type: Interventional

Funder types: Industry

Identifiers

NCT05959031

MagneticTides

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

active kTMP

Experimental group

Description:

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

Treatment:

Device: kTMP

sham kTMP

Sham Comparator group

Description:

Participants received 0.01 V/m of sham stimulation.

Treatment:

Device: Sham kTMP