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NCT Number: NCT07277595

kTMP in Chronic Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

kTMP sham stimulation 9 weeks + active stimulation 9 weeks

Device

kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation

kTMP 18 weeks

Device

Participants receive kTMP active stimulation for 18 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Karunesh Ganguly, MD, PhD

CONTACT

[email protected]

415-514-1252

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

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

Acronym: KULMINATE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Dec 11, 2025
Registry last updated
May 6, 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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