StrokeNCT07631078
kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot
A study testing kTMP in people with Stroke and Chronic Stroke Patients, run by Magnetic Tides 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to Aug 2028
- Phase
- Interventional
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 aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.
- Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.
- Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.
- Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).
Who cannot join
- Participants with moderate or severe cognitive impairment (MMSE < 18).
- Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).
- Participants with severe apraxia (TULIA < 5).
- Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.
- Individuals who have a serious uncontrolled medical condition, including but not limited to severe cardiovascular and cardiopulmonary disease.
- Pregnancy or plans to become pregnant during the study period.
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- Botulinum toxin injections of the affected upper extremity within 3 months prior to onset of study.
- Severe spasticity of the affected upper limb (Modified Ashworth ≥ 4).
- 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
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, 1 recruiting
- Recruiting
UCSF Mission Bay- Sandler Neurosciences Center
San Francisco, California, 94158
Christina Merrick, 510-423-7125, participate@magnetictides.com
Ludovica Labruna, PhD
About this study
Official title: 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.
Read the 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.
- Being tested
- kTMP, Sham kTMP
- Keywords
- kTMP, Ischemic Stroke, Hemorrhagic Stroke, Cortical Excitability, Plasticity, kilohertz Transcranial Magnetic Perturbation, Cerebrovascular Disorders, Stroke, Chronic Stroke, Transcranial Magnetic Stimulation, Non-Invasive Brain Stimulation, Brain Disorders, Central Nervous System Disorders, Cardiovascular Disorders
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kTMPDevice
A new non-invasive brain stimulation tool
Sham kTMPDevice
A new non-invasive brain stimulation tool with sham setting selected
| Study group | Role | What they receive |
|---|---|---|
| Active kTMP | Experimental | Participants received 8 V/m of active stimulation Receives: Device: kTMP |
| Sham kTMP | Sham comparator | Participants receive sham stimulation (0.0 V/m electric field) Receives: Device: Sham kTMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Quality Index (MQI)
Kinematic data will be captured using a markerless, three-camera motion tracking system during a standardized reach-to-grasp task, with 30 trials per assessment. The cameras will reconstruct 3D hand, arm, and shoulder motion.
The primary outcome is change from baseline in the Movement Quality Index (MQI), compared between kTMP and sham groups. MQI is a composite kinematic score calculated as range of motion (ROM) divided by trial-to-trial variability (T2TV), both derived from the 3D reconstructions:
ROM: range, speed, and smoothness of hand/arm motion, including elbow and shoulder joint angles. T2TV: consistency across trials, measured as variance of 3D trajectories around the mean trajectory.
Measured: Enrollment, then weeks 4, 6, 10, 18, 30
Secondary outcomes (7)
Fugl- Meyer Assessment (Upper Extremity) FMA-UE
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 4, 6, 10, 18, 30
Modified Ashworth Scale (MAS)
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: Enrollment, then weeks 4, 6, 10, 18, 30
Stroke Impact Scale (SIS)
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: Enrollment, then weeks 4, 6, 10, 18, 30
EuroQOL (EQ-5D)
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: Enrollment, then weeks 4, 6, 10, 18, 30
Motor Activity Log (MAL)
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: Enrollment, then weeks 4, 6, 10, 18, 30
Wolf Motor Function Test (WMFT)
A quantitative measure of upper extremity motor abilitythrough timed and functional tasks will be administered by a trained experimenter.
Measured: Enrollment, then weeks 4, 6, 10, 18, 30
Stroke Specific QOL (SSQOL)
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 4, 6, 10, 18, and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completionAug 2028 (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.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magnetic Tides
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, San Francisco, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631078
- Sponsor's protocol ID
- kTMPstrokePilot
- Status last verified
- Sep 2026
- First submitted
- 1 Jun 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No