kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot

June 1, 2026 updated by: Magnetic Tides

kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery

kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this pilot clinical trial is to assess the feasibility and preliminary efficacy of kTMP on upper limb motor recovery in chronic stroke compared to sham. We will conduct a 6-week double-blind, randomized, sham-controlled pilot study to test the beneficial influence of kTMP combined with simple motor tasks on kinematic outcomes such as range of motion of the upper arm, hand and fingers.

After baseline assessments, participants will be randomly allocated to either the kTMP group or the Control group. Participants, experimentalists, and outcome assessors will be blinded to group allocation. kTMP will begin within 1 week following randomization and will be delivered three times a week for 6 weeks. The primary endpoint will be assessed at the end of treatment, with follow-up assessments occurring 1 month, 3 months and 6 months following treatment completion. There is one assessment 4 weeks into the treatment phase to assess if patients continue to improve from 4 to 6 weeks of treatment.

Study Type

Interventional

Enrollment (Estimated)

12

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 Contact

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Recruiting
        • Magnetic Tides, Inc.
        • Contact:
        • Principal Investigator:
          • Ludovica Labruna, PhD
        • Principal Investigator:
          • Richard Ivry, PhD

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 an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
  2. Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
  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 < 4/8).
  3. Participants with severe apraxia (TULIA < 5).
  4. Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
  5. Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
  6. Pregnancy or plans to become pregnant during the study period.
  7. Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
  8. Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
  9. Absolute contraindications related to non-invasive brain stimulation, including:

9a) History of seizures in the last 12 months while taking anti-epilepsy medication 9b) 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 9c) Permanent eye liner or head tattoos 9d) Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator 9e) 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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active kTMP
Participants received 8 V/m of active stimulation
Device: kTMP
A new non-invasive brain stimulation tool
Sham Comparator: Sham kTMP
Participants receive sham stimulation (0.0 V/m electric field)
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
Range of Joint Motion (ROM)
Time Frame: 6 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
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl- Meyer Assessment (Upper Extremity)
Time Frame: 6 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.
6 weeks
Modified Ashworth Scale (MAS)
Time Frame: 6 weeks
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.
6 weeks
Transport Time
Time Frame: 6 weeks
Calculated for each of three epochs, pre, during and post
6 weeks
Trial to Trial Variability (T2TV)
Time Frame: 6 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.
6 weeks
Grasp to Lift Time
Time Frame: 6 weeks
Calculated for each of three epochs, pre, during and post
6 weeks

Collaborators and Investigators

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

Sponsor

Magnetic Tides

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)
University of California, San Francisco

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)

July 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • kTMPstrokePilot

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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