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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment kTMP Brain Stimulation for Healthy Individuals?

The research on repetitive transcranial magnetic stimulation (rTMS), a similar treatment, shows it can be effective for conditions like depression and neuropathic pain. High-frequency rTMS has been found to improve symptoms in these conditions, suggesting potential benefits for brain stimulation therapies. ^{1 2 3 4 5}

Is kTMP brain stimulation safe for healthy individuals?

Repetitive transcranial magnetic stimulation (rTMS), which is similar to kTMP, has been studied for safety in both healthy people and those with certain brain conditions. Common side effects are usually mild, like headaches, and the risk of serious issues like seizures is low when guidelines are followed. Overall, rTMS is considered safe, but long-term effects are still being studied. ^{6 7 8 9 10}

How does kTMP Brain Stimulation differ from other treatments for brain stimulation?

kTMP Brain Stimulation is unique because it uses theta burst stimulation (TBS), a form of transcranial magnetic stimulation (TMS) that can change brain activity quickly and for a longer duration compared to other methods. This treatment is non-invasive and targets specific brain areas to enhance or reduce their activity, which is different from traditional brain stimulation techniques that may not offer the same precision or lasting effects. ^{11 12 13 14 15}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Analgesic effects of repetitive transcranial magnetic stimulation of the motor cortex in neuropathic pain: influence of theta burst stimulation priming. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). [2020]

3. Poland pubmed.ncbi.nlm.nih.gov

The use of MR‑less MNI based neuronavigation for 10 Hz rTMS depression therapy: electrophysiological and clinical implications. [2019]

4. France pubmed.ncbi.nlm.nih.gov

Cognitive effects of precentral cortical stimulation for pain control: an ERP study. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Sham or real--post hoc estimation of stimulation condition in a randomized transcranial magnetic stimulation trial. [2015]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A review of the safety of repetitive transcranial magnetic stimulation as a clinical treatment for depression. [2021]

9. Netherlands 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. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Image-guided TMS is safe in a predominately pediatric clinical population. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Exploring the after-effects of theta burst magnetic stimulation on the human motor cortex: a functional imaging study. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Modulation of somatosensory evoked potentials using transcranial magnetic intermittent theta burst stimulation. [2008]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Intra- and Inter-Regional Priming of Ipsilateral Human Primary Motor Cortex With Continuous Theta Burst Stimulation Does Not Induce Consistent Neuroplastic Effects. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Use of theta-burst stimulation in changing excitability of motor cortex: A systematic review and meta-analysis. [2022]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Local Differences in Cortical Excitability - A Systematic Mapping Study of the TMS-Evoked N100 Component. [2021]