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Enrolling by invitation NCT05959031

Parameter Space of kTMP

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: kTMP, Sham kTMP.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Exploring the Parameter Space of High Frequency Magnetic Perturbation in Manipulating Neural Excitability and Plasticity.

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
  • Self-reported sensation/discomfort through questionnaire after kTMP stimulation. [Time frame: Measures will be obtained 1 minute after kTMP stimulation.]
  • Motor evoked potential (MEPs) amplitude recorded with electromyography (EMG) before kTMP stimulation. [Time frame: Measures will be obtained from 0 to 15 minutes before the stimulation.]
  • Motor evoked potential (MEPs) amplitude recorded with EMG after kTMP stimulation. [Time frame: Measures will be obtained 1 hour 30 minutes after the stimulation.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Device feasibility

Study locations

United States · 1 center
  • Magnetic Tides — El Cerrito

Identifiers

NCT: NCT05959031 · MagneticTides

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗