StrokeKULMINATENCT07277595
kTMP in Chronic Stroke
A study testing kTMP 18 weeks in people with Stroke and Chronic Stroke Patients, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Chronic Stroke Patients, Arm Weakness as a Consequence of Stroke
- What is being tested?
- kTMP 18 weeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Significant cognitive impairment
- inability to adhere to the study protocol or provide informed consent
- pregnancy
- additional criteria may apply
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, San Francisco
San Francisco, California, 94158
About this study
Official title: 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.
- Being tested
- kTMP sham stimulation 9 weeks + active stimulation 9 weeks, kTMP 18 weeks
- Keywords
- transcranial magnetic stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kTMP sham stimulation 9 weeks + active stimulation 9 weeksDevice
kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation
kTMP 18 weeksDevice
Participants receive kTMP active stimulation for 18 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Active comparator | Active treatment with kTMP for 18 weeks Receives: Device: kTMP 18 weeks |
| Crossover Treatment | Other | Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment. Receives: Device: kTMP sham stimulation 9 weeks + active stimulation 9 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment
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.
Measured: Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.
Secondary outcomes (7)
Wolf Motor Function Test
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Stroke Impact Scale
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Stroke Specific QOL
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
EuroQOL
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Motor Activity Log
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Modified Ashworth Scale Scores
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Action Research Arm Test
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.
Measured: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Karunesh Ganguly, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277595
- Sponsor's protocol ID
- 25-43524
- Other IDs
- R44NS139730
- Acronym
- KULMINATE
- Status last verified
- May 2026
- First submitted
- 2 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KTMP: A Novel Method of Non-invasive Brain Stimulation to Enhance Motor Function in Chronic Stroke Patients.
- ClinicalTrials.gov ID
- NCT07277595
- Acronym / sponsor ID
- KULMINATE / 25-43524
- Keywords
- transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Active comparator | Device: kTMP 18 weeksActive treatment with kTMP for 18 weeks |
| Crossover Treatment | Other | Device: kTMP sham stimulation 9 weeks + active stimulation 9 weeksInitial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Significant cognitive impairment
- inability to adhere to the study protocol or provide informed consent
- pregnancy
- additional criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kTMP sham stimulation 9 weeks + active stimulation 9 weekskTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation | Device | Crossover Treatment |
| kTMP 18 weeksParticipants receive kTMP active stimulation for 18 weeks | Device | Active Treatment |
Primary outcome
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.
7 secondary outcomes
Wolf Motor Function Test
Time frame: 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
Stroke Specific QOL
Time frame: 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
Motor Activity Log
Time frame: 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
Action Research Arm Test
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karunesh Ganguly, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kTMP 18 weeks in people with Stroke and Chronic Stroke Patients, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karunesh Ganguly, MD, PhD (415-514-1252, karunesh.ganguly@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Assessment (time frame: Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.