Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke

June 26, 2026 updated by: Magnetic Tides
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in stroke patients. This study has a crossover design comparing low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude modulation in kTMP on upper extremity kinematics 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 short-term effects of kTMP on reach-to-grasp kinematics. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate short term changes in motor performance.

Study Type

Interventional

Enrollment (Estimated)

7

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
      • Berkeley, California, United States, 94704
        • Magnetic Tides Inc.

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. Adults aged 18-80 years who have a history of a unilateral stroke ≥ 12 m prior to enrollment.
  2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-55.
  3. Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
  4. Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).

Exclusion Criteria:

  1. Participants with moderate or severe cognitive impairment (MoCA < 18).
  2. Participants with sensory deficits FMA-S ≥ 6/12 (with proprioception ≥ 2/4).
  3. Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
  4. Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
  5. Pregnancy or plans to become pregnant during the study period.
  6. Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study assessments/testing through the last visit.
  7. Severe spasticity of the affected upper limb (Modified Ashworth ≥ 3).
  8. Absolute contraindications related to non-invasive brain stimulation, including:

History of seizures in the last 12 months while taking anti-epilepsy medication Presence of any metal implants in the head (excluding the mouth), such as cortical stimulators and DBS, clips, coils, shunts, stents or skull plates, cochlear implants Permanent eye liner or head tattoos Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stimulation Condition A
Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude
Device: kTMP
A new non-invasive brain stimulation tool
Experimental: Stimulation Condition B
Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude
Device: kTMP
A new non-invasive brain stimulation tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reach-to-grasp (Range of Motion)
Time Frame: 3 weeks
Defined as the standard deviation of the joint angle time series for a given trial. The average will be computed over a set of 15 trials.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl- Meyer Assessment (Upper Extremity)
Time Frame: 3 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.
3 weeks
Modified Ashworth Scale (MAS)
Time Frame: 3-weeks
Clinical tool for measuring muscle spasticity and increased muscle tone. The MAS is a 6-point scale (0, 1, 1+, 2, 3, 4) measuring spasticity from no increase in tone to rigid limbs.
3-weeks

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 (Actual)

February 10, 2026

Primary Completion (Estimated)

June 26, 2027

Study Completion (Estimated)

June 26, 2027

Study Registration Dates

First Submitted

June 26, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Magnetic Tides Inc

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

Yes

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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