A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients

Last updated: May 9, 2025
Sponsor: Magnetic Tides
Overall Status: Active - Enrolling

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

Sham kTMP

kTMP

Clinical Study ID

NCT06317194
Magnetic Tides
  • Ages 18-75
  • All Genders

Study Summary

Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Age 18 or older with stable upper limb motor dysfunction caused by a single ischemicand/or hemorrhagic stroke greater than 6 months prior to recruitment

  2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 28-60

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

Exclusion

Exclusion criteria:

  1. Participants with cognitive impairment (MoCA < 20), language impairment thatinterferes with their ability to adhere to the protocol or to provide informedconsent.

  2. Individuals who are pregnant, have uncontrolled medical problems including but notlimited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drugabuse within the past year, or major depression.

  3. Contraindications related to non-invasive brain stimulation

Study Design

Total Participants: 15
Treatment Group(s): 2
Primary Treatment: Sham kTMP
Phase:
Study Start date:
September 15, 2025
Estimated Completion Date:
August 30, 2027

Study Description

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 patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.

The trial aims to evaluate the preliminary efficacy of kTMP in improving upper limb motor performance in patients suffering from chronic stroke. This clinical trial aims to target the perilesional motor cortex to assess both immediate and long-term improvement of motor performance, and corresponding physiological changes induced by kTMP stimulation.

Connect with a study center

  • Magnetic Tides

    El Cerrito, California 94530
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.