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

NCT ID: NCT06317194

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2027-08-30

Brief 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.

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Active kTMP

Participants received 2-8 V/m of active stimulation

Group Type: EXPERIMENTAL

kTMP

Intervention Type: DEVICE

A new non-invasive brain stimulation tool

Sham kTMP

Participants received 0.01 V/m of sham stimulation

Group Type: SHAM_COMPARATOR

Sham kTMP

Intervention Type: DEVICE

A new non-invasive brain stimulation tool with sham setting selected

Interventions

kTMP

A new non-invasive brain stimulation tool

Intervention Type: DEVICE

Sham kTMP

A new non-invasive brain stimulation tool with sham setting selected

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Berkeley

OTHER

Sponsor Role: collaborator

Magnetic Tides

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Magnetic Tides

El Cerrito, California, United States

Countries

United States

Other Identifiers

Magnetic Tides

Identifier Type: -

Identifier Source: org_study_id