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

NCT06317194 | Enrolling By Invitation

• 1 other identifier: Magnetic Tides
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

kTMP; Motor Rehabilitation; Ischemic Stroke; Hemorrhagic Stroke; Cerebrovascular disease; Cortical Excitability; Plasticity; Neuroscience; Stroke; Central Nervous System Disease; kilohertz Transcranial Magnetic Perturbation

Outcome Measures

Primary Outcomes (1)

• Fugl- Meyer Assessment (Upper Extremity)

  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 Outcomes (6)

• Action Research Arm Test (ARAT)

  10 months

• Modified Ashworth Scale (MAS)

  10 months

• Trial to Trial Variability (T2TV)

  10 months

• Range of Joint Motion (ROM)

  10 months

• Grasp to Lift Time

  10 months

Study Arms (2)

Active kTMP

EXPERIMENTAL

Participants received 2-8 V/m of active stimulation

Device: kTMP

Sham kTMP

SHAM COMPARATOR

Participants received 0.01 V/m of sham stimulation

Device: Sham kTMP

Interventions

kTMP DEVICE

A new non-invasive brain stimulation tool

Active kTMP

Sham kTMP DEVICE

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

Sham kTMP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 28-60
• Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function.

You may not qualify if:

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

Sponsors & Collaborators

• Magnetic Tides: lead
• University of California, Berkeley: collaborator

Study Sites (1)

Magnetic Tides

El Cerrito, California, 94530, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 19, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)