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NCT Number: NCT06317194

Pilot Study: A Novel Method of Non-Invasive Brain Stimulation (kTMP) 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 feasibility and efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Magnetic Tides, Inc.

Berkeley, California, 94704, United States

About this study

The goal of this pilot clinical trial is to test the feasibility of 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 also aims to assess the preliminary effects of kTMP on upper limb motor performance in individuals with chronic stroke. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate both immediate and longer-term changes in motor performance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-80 years 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 20-50
  • 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

  • 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

Treatment and study plan

kTMP

Device

A new non-invasive brain stimulation tool

Primary outcomes

  1. Fugl- Meyer Assessment (Upper Extremity)

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Movement smoothness of Reach-to-Grasp

    Time frame: 8 weeks

    Movement smoothness of the reach phase will be quantified using three-dimensional hand kinematics recorded via an electromagnetic motion capture system.

    Spectral Arc Length (SPARC): A frequency-domain measure of movement smoothness (Balasubramanian et al., 2015, Journal of NeuroEngineering and Rehabilitation). More negative values indicate less smooth, more fragmented movement.

  2. Action Research Arm Test (ARAT)

    Time frame: 8 weeks

    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.

  3. Trial to Trial Variability (T2TV)

    Time frame: 8 weeks

    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.

  4. Range of Joint Motion (ROM)

    Time frame: 8 weeks

    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

  5. Grasp to Lift Time

    Time frame: 8 weeks

    Calculated for each of three epochs, pre, during and post

  6. Transport Time

    Time frame: 8 weeks

    Calculated for each of three epochs, pre, during and post

Sponsors and collaborators

Lead sponsor

Magnetic Tides

Industry

Collaborators

  • University of California, Berkeley

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2024
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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