kTMP for Stroke

(KULMINATE Trial)

Overseen By Karunesh Ganguly, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Cognitive impairment, Pregnancy, others

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

Compensation: Varies

Number of Visits: 37

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called kTMP, which uses gentle magnetic pulses to improve arm and hand movement in stroke survivors. The goal is to assess how well kTMP aids those with difficulty using one side of their body due to stroke. Participants will either receive the active treatment for 18 weeks or start with a placebo for 9 weeks before switching to the real treatment. This study suits adults who have experienced a stroke resulting in limited movement on one side of their body and who can understand and communicate clearly. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance stroke recovery treatments.

Do I need to stop my current medications to join 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 or your doctor.

What prior data suggests that this technique is safe for stroke rehabilitation?

Research has shown that kilohertz transcutaneous magnetic perturbations (kTMP) are safe and well-tolerated. Studies have demonstrated that kTMP can influence brain activity without causing harm. This non-invasive method does not involve surgery or entering the body. Early results suggest that kTMP can enhance brain function using gentle magnetic pulses. No serious side effects have been reported, making it a promising option for stroke recovery. This evidence supports the safety of kTMP for use in human treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stroke focus on restoring blood flow or protecting brain tissue from damage. But kTMP works differently, targeting neural pathways to potentially enhance recovery. Unlike the standard approaches, kTMP is designed to be used after a stroke has occurred, aiming to improve brain function and repair. Researchers are excited about kTMP because it offers a novel approach to stroke recovery that could complement existing therapies and provide new hope for patients looking to regain lost abilities.

What evidence suggests that kTMP is effective for stroke rehabilitation?

Research shows that kTMP, or kilohertz transcutaneous magnetic perturbations, might improve movement in stroke survivors. Earlier tests with healthy individuals demonstrated that kTMP successfully altered brain activity, suggesting potential benefits for recovery. This non-invasive method does not involve surgery or entering the body. The FDA has recognized kTMP as a Breakthrough Device, highlighting its potential in stroke recovery. In this trial, participants will either receive active kTMP treatment for 18 weeks or undergo a crossover treatment, starting with 9 weeks of sham kTMP treatment followed by 9 weeks of active kTMP treatment. Although more research is needed, early results suggest kTMP could be a valuable tool for regaining arm and hand movement after a stroke. ^{1 6 7 8 9}

Who Is on the Research Team?

Karunesh Ganguly, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing arm weakness as a result. Participants should be in the chronic phase of their stroke recovery to qualify.

Inclusion Criteria

I can understand and consent to medical procedures.

I am between 18 and 80 years old and had a stroke that caused paralysis on one side.

Other criteria may apply

Exclusion Criteria

Significant cognitive impairment

Inability to adhere to the study protocol or provide informed consent

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Active treatment with kTMP for 18 weeks or crossover treatment with 9 weeks of sham followed by 9 weeks of active kTMP

18 weeks

Visits at enrollment, then weeks 3, 6, 9, 12, 15, 18

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

Visit at week 34

What Are the Treatments Tested in This Trial?

Interventions

• kTMP

Trial Overview

The study is testing kTMP, which stands for kilohertz transcutaneous magnetic perturbations. It's a type of low-intensity brain stimulation aimed at helping with arm and hand rehabilitation post-stroke. One group will receive sham stimulation followed by active treatment, while another gets continuous active treatment for 18 weeks.

How Is the Trial Designed?

Group I: Crossover Treatment Experimental Treatment 1 Intervention

Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment.

Group II: Active Treatment Active Control 1 Intervention

Active treatment with kTMP for 18 weeks

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07277595

Study Details | NCT07277595 | kTMP in Chronic Stroke

An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.

2.

elifesciences.org

elifesciences.org/reviewed-preprints/92088

A New Non-invasive Method to Modulate Cortical Excitability

We report here the results of three experiments with healthy human participants that evaluate the efficacy of kTMP in modulating cortical ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11345365/

Effectiveness of computed tomography perfusion imaging ...

When CTP results were negative, 43% of the cases turned out to stroke mimics. Patients with stroke mimics were younger (66 ± 17 vs. 73 ± 13) and ...

4.

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 ...

5.

linkedin.com

linkedin.com/posts/ludovica-labruna_magnetictides-strokerecovery-neurology-activity-7367006414877184001-O1fH

FDA grants Breakthrough Device Designation to kTMP for ...

The FDA has granted kTMP Breakthrough Device Designation! This is a major milestone in Magnetic Tides' mission to help chronic stroke ...

6.

pmc.ncbi.nlm.nih.gov

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

Kilohertz transcranial magnetic perturbation (kTMP) as a new ...

The NIBS E-field can safely manipulate neural excitability, providing neuroscientists with a powerful tool to advance our understanding of brain function.

7.

elifesciences.org

elifesciences.org/articles/92088

Kilohertz transcranial magnetic perturbation (kTMP) as a ...

kTMP is a novel, non-invasive brain stimulation method that, via continuous magnetic induction, safely and effectively increases cortical ...

8.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0020609

Stroke (DBCOND0020609)

A compound complexed with technetium 99 used in single photon emission computerized tomography to localize a stroke. A proteolytic protein indicated in the ...

9.

datadryad.org

datadryad.org/dataset/doi:10.5061/dryad.qz612jmsh

A new non-invasive method to modulate cortical excitability

README: Data for: Kilohertz Transcranial Magnetic Perturbation (kTMP): A new non-invasive method to modulate cortical excitability.