Non-Invasive Brain Stimulation for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Magnetic Tides

Disqualifiers: Cognitive impairment, Pregnancy, Severe cardiovascular, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new, non-invasive brain stimulation system called kTMP to improve movement issues after a stroke. It targets individuals who experienced a stroke over six months ago and continue to have difficulty using their upper limbs. Participants will receive either active stimulation or a sham (fake) version to determine the treatment's effectiveness. Those who have had a stroke and still struggle with arm or hand movements might find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance recovery options for stroke survivors.

Will I have to stop taking my current medications?

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 or your doctor.

What prior data suggests that this non-invasive brain stimulation system is safe for stroke patients?

Research has shown that kTMP, a non-surgical brain stimulation method, is generally safe. In past studies, similar methods caused only minor side effects. Most participants experienced mild issues such as tingling in 37% of cases, burning in 19%, and headaches and fatigue in about 15% of cases. These side effects are typically not serious and resolve on their own.

This type of brain stimulation has also helped individuals regain language skills after a stroke, demonstrating good safety results. Overall, kTMP appears well-tolerated, but individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about kTMP for stroke recovery because it offers a non-invasive way to stimulate the brain, potentially enhancing recovery without the need for surgery or medication. Unlike traditional stroke treatments that may rely on medications like clot-busters or physical rehabilitation, kTMP uses targeted electrical fields to encourage brain activity and repair. This method could provide a new pathway for recovery by directly engaging brain cells in a safe and controlled manner, making it a promising complement or alternative to existing therapies.

What evidence suggests that this non-invasive brain stimulation system is effective for stroke?

Research has shown that kTMP, a non-surgical method, can improve movement skills. Studies with healthy individuals found that kTMP can alter brain activity, which is crucial for enhancing motor skills. This trial will compare two approaches: participants in one arm will receive active kTMP, which adjusts the brain's movement area responses, while participants in the other arm will receive sham kTMP. Early tests suggested that active kTMP can help stroke survivors improve movement. Although more research is needed, these early results offer promise for those with movement difficulties after a stroke. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are living with chronic motor function impairments. Specific eligibility criteria details were not provided, so it's important to contact the study organizers for more information on who can participate.

Inclusion Criteria

I am 18 or older and have had stable arm problems due to a stroke over 6 months ago.

My arm and hand movement score is between 28 and 60.

Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function

Exclusion Criteria

Contraindications related to non-invasive brain stimulation

Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression

I do not have cognitive or language issues that affect my understanding or decision-making.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive kTMP or sham stimulation to assess motor function improvement

10 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• kTMP

Trial Overview The trial is testing kTMP, an innovative non-invasive brain stimulation system designed to improve motor functions in people who have suffered from a stroke. Participants will be randomly assigned to receive either kTMP or a sham (fake) treatment as a comparison.

How Is the Trial Designed?

Group I: Active kTMP Experimental Treatment 1 Intervention

Participants received 2-8 V/m of active stimulation

Group II: Sham kTMP Placebo Group 1 Intervention

Participants received 0.01 V/m of sham stimulation

Who Is Running the Clinical Trial?

Magnetic Tides

Lead Sponsor

Trials

2

Recruited

220+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Published Research Related to This Trial

Deep brain stimulation is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

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]

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]

Noninvasive cortical stimulation techniques are valuable in neurorehabilitation, helping researchers understand how the brain recovers function after injury.

These techniques can modulate cortical excitability, potentially enhancing the effects of rehabilitation training and providing insights into the physiological mechanisms behind recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive cortical stimulation in neurorehabilitation: a review. Harris-Love, ML., Cohen, LG.[2016]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06317194/a-novel-method-of-non-invasive-brain-stimulation-ktmp-to-enhance-motor-function-in-chronic-stroke-patients

A Novel Method of Non-Invasive Brain Stimulation (kTMP) ... The goal of this clinical trial is to test and validate a novel first-in-class non-invasive approach to enhance motor function in chronic stroke ...

2. elifesciences.org elifesciences.org/articles/92088

Kilohertz transcranial magnetic perturbation (kTMP) as a ... We report here the results of three experiments with healthy human participants that evaluate the efficacy of kTMP in modulating cortical ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05959031

Study Details | NCT05959031 | Parameter Space of kTMP This outcome measures device feasibility in terms of efficacy, as MEP changes indicate changes in cortical excitability induced by kTMP. After the kTMP ...

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

Kilohertz transcranial magnetic perturbation (kTMP) as a new ... We report here the results of three experiments with healthy human participants that evaluate the efficacy of kTMP in modulating cortical excitability. Adopting ...

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.047483

Decreased Quantitative Cerebral Blood Volume Is ... CBV<42% ≥68 mL most effectively forecasts poor outcomes in patients with large-core stroke, confirming its value alongside other parameters like ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10783273/

The effectiveness and safety of noninvasive brain stimulation ... The NIBS technique combined with speech training can effectively improve the recovery of language function in PSA patients with minimal adverse effects.

7. tandfonline.com tandfonline.com/doi/abs/10.1080/10749357.2022.2058294

Safety and Adverse Events following Non-invasive ... The most frequently reported adverse events were tingling (37.3% of papers), burning (18.7%), headaches (14.7%) and fatigue (14.7%). Cathodal stimulation was ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0006899324003470

Can non-motor outcomes be improved in chronic stroke? A ... Our findings highlight the potential of NIBS, such as tDCS and rTMS, in the cognitive, linguistic, and emotional recovery of post-stroke patients.

9. journals.lww.com journals.lww.com/md-journal/fulltext/2024/01120/the_effectiveness_and_safety_of_noninvasive_brain.53.aspx

The effectiveness and safety of noninvasive brain... The NIBS technique combined with speech training can effectively improve the recovery of language function in PSA patients with minimal adverse effects.