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

May 9, 2025 updated by: Magnetic Tides

A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • El Cerrito, California, United States, 94530
        • Magnetic Tides

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Age 18 or older with stable upper limb motor dysfunction caused by a single ischemic and/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 with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function.

Exclusion criteria:

  1. Participants with cognitive impairment (MoCA < 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent.
  2. 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.
  3. Contraindications related to non-invasive brain stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active kTMP
Participants received 2-8 V/m of active stimulation
Device: kTMP
A new non-invasive brain stimulation tool
Sham Comparator: Sham kTMP
Participants received 0.01 V/m of sham stimulation
Device: Sham kTMP
A new non-invasive brain stimulation tool with sham setting selected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl- Meyer Assessment (Upper Extremity)
Time Frame: 10 months
A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test (ARAT)
Time Frame: 10 months
A standardized assessment of functional hand motor performance measured by four basic movements used in everyday life (gross arm movement, grasp, grip and pinch). The scores range from 0 to 57. Higher score means a better arm motor status.
10 months
Modified Ashworth Scale (MAS)
Time Frame: 10 months
Used to measure spasticity in wrist and hand flexors and extensors. It assigns a grade of spasticity from 0-4. Lower scores represent normal muscle tone and higher scores represent spasticity. Hence lower scores are associated with better outcomes.
10 months
Trial to Trial Variability (T2TV)
Time Frame: 10 months
Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries. The median T2TV will be calculated for eleven degrees of freedom.
10 months
Range of Joint Motion (ROM)
Time Frame: 10 months
defined as the standard deviation of the joint angle time series for a given trial. The median ROM will be calculated for eleven degrees of freedom and then averaged. If there are joints which appear to be compensatory, they will be removed from the analysis
10 months
Grasp to Lift Time
Time Frame: 10 months
Calculated for each of three epochs, pre, during and post
10 months
Transport Time
Time Frame: 10 months
Calculated for each of three epochs, pre, during and post
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Magnetic Tides

Collaborators

University of California, Berkeley

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 30, 2027

Study Registration Dates

First Submitted

March 5, 2024

First Submitted That Met QC Criteria

March 11, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Magnetic Tides

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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