Clinical trial NCT05959031: Parameter Space of kTMP
Official title: Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy
Lead sponsor: Magnetic Tides
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported sensation/discomfort through questionnaire during kTMP stimulation.
timeFrame: 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.
measure: Self-reported sensation/discomfort through questionnaire after kTMP stimulation.
timeFrame: Measures will be obtained 1 minute after kTMP stimulation.
measure: Motor evoked potential (MEPs) amplitude recorded with electromyography (EMG) before kTMP stimulation.
timeFrame: Measures will be obtained from 0 to 15 minutes before the stimulation.
measure: Motor evoked potential (MEPs) amplitude recorded with EMG after kTMP stimulation.
timeFrame: Measures will be obtained 1 hour 30 minutes after the stimulation.
Secondary outcomes:
Other outcomes:
Locations:
city: El Cerrito
country: United States
facility: Magnetic Tides
state: California
Study officials:
References: