SBIR_2022: Parameter Space of kTMP
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: active kTMP Participants received 0.5 - 8 V/m of active stimulation. |
Device: kTMP
a New Non-invasive Brain Stimulation Tool
|
| Sham Comparator: sham kTMP Participants received 0.01 V/m of sham stimulation. |
Device: kTMP
a New Non-invasive Brain Stimulation Tool
|
Outcome Measures
Primary Outcome Measures
- Self-reported sensation/discomfort through questionnaire during kTMP stimulation. [Measures will be obtained 4-5 s 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.]
To estimate the stimulation threshold, the investigators will use an adaptive procedure in which they sequentially increase the stimulation intensity (E-field amplitude) and register self-reports of sensation, until they reach noticeable levels. Stimulation intensity will start from 0.01 V/m (sham) increasing 0.5 V/m at a time for 16 trials until it reaches 7.6 V/m. The primary intervention of interest is the kTMP system, with various manipulations of the parameter settings. Participants provided three ratings using an 11-point scale (0 = not at all; 10 = extremely) in response to questions on annoyance, pain, and muscle twitching. ("How annoying was kTMP?", "How painful was kTMP?", and "If there were any muscle twitches from the kTMP, how strong were they?") A higher score means more sensation/discomfort, therefore a worse outcome.
- Self-reported sensation/discomfort through questionnaire after kTMP stimulation. [Measures will be obtained 1 minute after kTMP stimulation.]
After the kTMP stimulation, the investigators will register self-reports of sensation from the participant to see any lasting effect in terms of sensation. Participants provided three ratings using an 11-point scale (0 = not at all; 10 = extremely) in response to questions on annoyance, pain, and muscle twitching. ("How annoying was kTMP?", "How painful was kTMP?", and "If there were any muscle twitches from the kTMP, how strong were they?") A higher score means more sensation/discomfort, therefore a worse outcome.
- Motor evoked potential (MEPs) amplitude recorded with electromyography (EMG) before kTMP stimulation. [Measures will be obtained from 0 to 15 minutes before the stimulation.]
As an operational definition of cortical excitability, the investigators will measure MEPs recorded in a peripheral hand muscle through the EMG system. The threshold procedure will be first conducted using single-pulse Transcranial magnetic stimulation (TMS) to find the M1 hotspot and threshold intensity. Once the threshold is set, MEPs will be obtained using the single-pulse and paired-pulse TMS procedures. These measurements will be taken prior to the experimental intervention of kTMP to obtain a baseline measure.
- Motor evoked potential (MEPs) amplitude recorded with EMG after kTMP stimulation. [Measures will be obtained 1 hour 30 minutes after the stimulation.]
After the kTMP stimulation as a plasticity-inducing technique, we obtain MEPs using the single-pulse and paired-pulse TMS procedures. MEPs will be recorded in a peripheral hand muscle through the EMG system. The primary intervention of interest is the kTMP system, with various manipulations of the parameter settings.
Eligibility Criteria
Criteria
Inclusion Criteria:
Age 18-75
Exclusion Criteria:
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serious medical condition
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had a seizure of any sort
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epilepsy or experienced seizures
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neurological disorder
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head injury
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stroke
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had any form of brain surgery
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history of migraine
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metal implants in your head, excluding the mouth
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pacemaker
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implanted medical devices of any sort
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pregnant
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hearing loss or hearing impairments
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jet lag
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stress
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substance abuse
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highly stressful even over the past 24 hours
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broken or abnormal skin on your scalp
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Magnetic Tides | El Cerrito | California | United States | 94530 |
Sponsors and Collaborators
- Magnetic Tides
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MagneticTides