kTMP in Chronic Stroke (KULMINATE)

May 1, 2026 updated by: University of California, San Francisco

KTMP: A Novel Method of Non-invasive Brain Stimulation to Enhance Motor Function in Chronic Stroke Patients.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California, San Francisco

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults age 18-80 years old who have had a stroke resulting in hemiplegia
  • Ability to communicate, understand, and give appropriate consent
  • Other criteria may apply

Exclusion Criteria:

  • Significant cognitive impairment
  • inability to adhere to the study protocol or provide informed consent
  • pregnancy
  • additional criteria may apply

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active Treatment
Active treatment with kTMP for 18 weeks
Device: kTMP 18 weeks
Participants receive kTMP active stimulation for 18 weeks
Other: Crossover Treatment
Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment.
Device: kTMP sham stimulation 9 weeks + active stimulation 9 weeks
kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fugl Meyer Assessment
Time Frame: Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.
The Fugl-Meyer Assessment (FMA) is a structured evaluation used to measure motor recovery after a stroke, with a total score range of 0-226. Higher scores indicate better motor function, while lower scores reflect greater impairment.
Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wolf Motor Function Test
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Measures timed functional tasks, strength testing, and analysis of movement quality when completing various upper extremity tasks. Uses a 6 point ordinal scale (0-5), where ) is does not attempt with the involved arm and 5 is arm does participate and movement appears normal. Maximum score of 75. Lower scores indicate lower functional levels.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Stroke Impact Scale
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Self reported questionnaire that evaluates disability and health related quality of life after stroke, consisting of 59 items, assessing strength, hand function, ADL/iADL, mobility, communication, emotion, memory and thinking, participation/role function. Each item is rated in a 5 point Likert scale, where 1 equals could not do it at all and 5 equals not difficult at all. Score ranges 0-100. Higher score indicates less disability and high quality of life after stroke.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Stroke Specific QOL
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Questionnaire consisting of 49 items in the 12 domains of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking and personality. Each item is assessed on a 5 point Guttman type scale, where 1=total help; couldn't do it at all; strongly agree and 5 =no help needed; no trouble at all; strongly disagree. Higher scores indicate better functioning.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
EuroQOL
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
A health questionnaire that measures 5 dimensions including mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each item is described by 3 levels of problems, where 1=none, 2=mild to moderate, and 3=severe. This provides a simple single index value for health status, where a higher score indicates worse health state.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Motor Activity Log
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Self reported perception of Quality of movement are rated in 30 functional tasks, scored on a 6 point ordinal scale where 0=weaker arm not used at all for that activity and 5=ability to use the weaker arm for that activity is as good as before the stroke(normal). A higher score indicates better quality upper extremity movement.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Modified Ashworth Scale Scores
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Test of resistance to passive movement about a joint, scores range from 0 to 5 where 0=no increase in muscle tone and 5=affected part(s) rigid. Hight scores indicate greater muscle tone.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Action Research Arm Test
Time Frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Measures performance of the upper extremity in grasp, grip, pinch, and gross arm movements, rated on a 4 point ordinal scale where 3=performs test normally and 0=can perform no part of test. Higher score indicates greater function of the upper extremity.
At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karunesh Ganguly, MD, PhD, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-43524
  • R44NS139730 (U.S. NIH Grant/Contract)

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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