kTMP Brain Stimulation for Healthy Individuals

(SBIR_2022 Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Magnetic Tides

Disqualifiers: Seizures, Neurological disorder, Stroke, Migraine, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 16 trials

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new brain stimulation device called kTMP to evaluate its safety and effectiveness in healthy individuals. The study compares two groups: one receiving active stimulation and the other receiving a sham (or fake) version to determine the real effects. The trial aims to fine-tune the device settings to ensure both tolerability and effectiveness. Individuals who are generally healthy and have not experienced seizures, head injuries, or neurological disorders may be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research and help shape future treatments.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this kTMP device is safe for brain stimulation?

Earlier studies have shown that kTMP, a new non-surgical brain stimulation method, safely boosts brain activity. This technique uses magnets to generate electric fields in the brain without requiring surgery or implants. Research indicates that participants generally tolerate these electric fields well, with no serious side effects reported so far. This suggests the treatment is usually safe for healthy individuals. However, as this method is new, ongoing research will help confirm its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about kTMP brain stimulation because it represents a novel approach to enhancing brain function in healthy individuals. Unlike traditional brain stimulation methods that often require invasive procedures or are limited to specific conditions, kTMP offers a non-invasive technique that uses varying levels of electric fields to potentially boost cognitive performance. This method could pave the way for safer, more versatile brain enhancement technologies, providing a new frontier in cognitive improvement without the need for medication or surgery.

What evidence suggests that this kTMP device is effective for modulating neural excitability?

Research has shown that kilohertz transcranial magnetic perturbation (kTMP) might be a promising method for brain stimulation. Early studies found that kTMP can boost brain activity in specific areas without causing discomfort. This trial will compare active kTMP, which uses high-frequency magnetic fields to stimulate brain cells, with sham kTMP. Initial results from previous studies indicated that active kTMP creates strong electric fields in the brain, potentially aiding various mental tasks. However, more research is needed to fully understand its effectiveness and potential benefits. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for healthy individuals aged 18-75 who haven't had a highly stressful event in the past day. It's not suitable for those with metal head implants (except dental), pregnancy, serious medical conditions, neurological disorders, brain surgery history, pacemakers, substance abuse issues, seizures or epilepsy history, head injuries or stroke survivors.

Exclusion Criteria

I have had a stroke in the past.

Pregnancy

I have been diagnosed with epilepsy or have had seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Motor evoked potential (MEPs) amplitude recorded with EMG before kTMP stimulation to obtain baseline measures

0-15 minutes

1 visit (in-person)

Treatment

Participants receive kTMP stimulation to assess tolerability and efficacy in producing changes in cortical physiology

16 trials

1 visit (in-person)

Post-Treatment Assessment

Self-reported sensation/discomfort and MEPs amplitude recorded with EMG after kTMP stimulation

1 hour 30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any lasting effects of the kTMP stimulation

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• kTMP

Trial Overview The study tests kTMP—a new non-invasive brain stimulation system—against a sham (fake) version to see how well it works and how tolerable it is. The goal is to find out if this device can safely change brain activity without causing harm.

How Is the Trial Designed?

Group I: active kTMP Experimental Treatment 1 Intervention

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

Group II: sham kTMP Placebo Group 2 Interventions

Participants received 0.01 V/m of sham stimulation.

Who Is Running the Clinical Trial?

Magnetic Tides

Lead Sponsor

Trials

2

Recruited

220+

Published Research Related to This Trial

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

Transcranial magnetic intermittent theta burst stimulation (iTBS) over the sensory cortex (S1) significantly enhanced somatosensory evoked potentials (SEPs) in healthy subjects, indicating its potential to facilitate sensory processing.

The effectiveness of iTBS was dependent on the position and direction of the stimulation coil, with no significant changes observed when applied over the motor cortex (M1), suggesting that iTBS can selectively modulate sensory pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of somatosensory evoked potentials using transcranial magnetic intermittent theta burst stimulation. Katayama, T., Rothwell, JC.[2008]

Theta burst stimulation (TBS) is a promising technique for altering brain excitability, with a review of studies showing that adverse events were mostly mild and occurred in only 5% of subjects, indicating a generally safe profile.

Despite its safety, TBS carries a theoretical higher risk of seizures compared to other stimulation methods, necessitating cautious application and further research into its dosing parameters to better understand seizure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. Oberman, L., Edwards, D., Eldaief, M., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) was found to be safe for a patient with an implanted subdural cortical electrode, showing no serious adverse effects during treatment.

Ex-vivo experiments indicated that rTMS caused only a slight increase in coil temperature and no displacement of the electrodes, suggesting that rTMS can be safely applied in clinical settings for patients with such implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Phielipp, NM., Saha, U., Sankar, T., et al.[2019]

High-frequency repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex is definitively effective for treating neuropathic pain, while high-frequency rTMS of the left dorsolateral prefrontal cortex is effective for depression, based on a comprehensive review of literature up to 2018 involving multiple studies.

Low-frequency rTMS has probable efficacy for various conditions, including improving motor recovery in stroke and quality of life in fibromyalgia, but the overall clinical relevance of rTMS benefits may vary and is not guaranteed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Lefaucheur, JP., Aleman, A., Baeken, C., et al.[2020]

In a study of 46 patients with drug-resistant depression, using a neuronavigated MR-less rTMS system allowed for targeted stimulation of different brain regions, leading to varying clinical outcomes and physiological effects.

Group 3, which received stimulation at a specific target, showed the greatest reduction in depression symptoms (66.94% decrease in HAM-D scores), suggesting that precise targeting in rTMS can enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of MR‑less MNI based neuronavigation for 10 Hz rTMS depression therapy: electrophysiological and clinical implications. Valiulis, V., Gerulskis, G., Dapšys, K., et al.[2019]

In a study involving 33 patients undergoing rTMS treatment, the sham condition used was effective as most participants could not distinguish between real and sham stimulation, indicating its suitability for clinical trials.

Both groups, those receiving real stimulation and those receiving sham, showed a high willingness to recommend rTMS to others, suggesting that the treatment is perceived positively regardless of the actual stimulation received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sham or real--post hoc estimation of stimulation condition in a randomized transcranial magnetic stimulation trial. Herwig, U., Cardenas-Morales, L., Connemann, BJ., et al.[2015]

Repetitive Transcranial Magnetic Stimulation (rTMS) has a good overall safety profile for treating depression, with common side effects like headaches being minor and manageable.

While there is a low incidence of serious side effects such as seizures and hypomania, these are linked to specific risk factors, suggesting that proper screening can enhance patient safety during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. Loo, CK., McFarquhar, TF., Mitchell, PB.[2021]

In a study involving 429 pediatric patients undergoing transcranial magnetic stimulation (TMS) for motor and language mapping, most adverse events were benign, with seizures occurring in 5.8% of sessions but not conclusively linked to TMS.

TMS was safely performed in patients with cranial metal, and useful mapping results were achieved in nearly all cases, indicating that TMS is a safe option for functional mapping in pediatric patients with epilepsy or brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. Braden, AA., Weatherspoon, SE., Boardman, T., et al.[2022]

Citations

1. elifesciences.org elifesciences.org/articles/92088

Kilohertz transcranial magnetic perturbation (kTMP) as a ... This important study introduces and evaluates the efficacy of a novel form of non-invasive brain stimulation in humans: kilohertz ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05959031

Study Details | NCT05959031 | Parameter Space of kTMP The investigators have recently developed a new non-invasive brain stimulation (NIBS) system, kilohertz transcranial magnetic perturbation (kTMP) that opens up ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408067/

Kilohertz transcranial magnetic perturbation (kTMP) as a new ... kTMP opens a new experimental NIBS space inducing relatively large amplitude subthreshold E-fields able to increase cortical excitability with minimal sensation ...

4. withpower.com withpower.com/trial/phase-healthy-subjects-hs-7-2022-5fde9

kTMP Brain Stimulation for Healthy Individuals · Info ... In a study involving 33 patients undergoing rTMS treatment, the sham condition used was effective as most participants could not distinguish between real and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024006254

Efficacy of brain stimulation therapies across psychiatric ... This review provides the most comprehensive summary to date of the effectiveness of BSTs across psychiatric, movement, and cognitive disorders.

6. elifesciences.org elifesciences.org/reviewed-preprints/92088

A New Non-invasive Method to Modulate Cortical Excitability kTMP is a magnetic induction method that delivers continuous kHz-frequency cortical electric fields (E-fields) which may be amplitude-modulated.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4459719/

Safety of Noninvasive Brain Stimulation in Children and ... Our findings indicate that both repetitive TMS and tCS are safe modalities in children and adolescents with various neurological conditions.