ClinicalTrials.gg
RecruitingNCT07631078Updated Sep 29, 2026

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

An interventional study of kTMP and Sham kTMP in Stroke, Chronic Stroke Patients and Arm Weakness as a Consequence of Stroke, sponsored by Magnetic Tides. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Magnetic Tides · Not applicable, Interventional, and Treatment

Updated Sep 29, 2026Start date movedEnrollment updated+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Stroke
  • Chronic Stroke Patients
  • Arm Weakness as a Consequence of Stroke

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
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 6 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Magnetic Tides is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 29, 2026. See what changed

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  1. Participants with moderate or severe cognitive impairment ( \< 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 .
  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 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

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
6 participants (estimated)

Study arms

  • Experimental
    Active kTMP

    Participants received 8 V/m of active stimulation

    Device: kTMP

  • Sham comparator
    Sham kTMP

    Participants receive sham stimulation (0.0 V/m electric field)

    Device: Sham kTMP

Interventions

  • DevicekTMP

    A new non-invasive brain stimulation tool

  • DeviceSham kTMP

    A new non-invasive brain stimulation tool with sham setting selected

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

Secondary outcomes

  1. 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.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

  2. 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.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

  3. 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.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

  4. 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.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

  5. 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.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

  6. Wolf Motor Function Test (WMFT)

    A quantitative measure of upper extremity motor abilitythrough timed and functional tasks will be administered by a trained experimenter.

    Time frame: Enrollment, then weeks 4, 6, 10, 18, 30

  7. 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.

    Time frame: At enrollment, then weeks 4, 6, 10, 18, and 30

07

Study locations

1 of 1 sites recruiting
  • UCSF Mission Bay- Sandler Neurosciences Center
    San Francisco, California 94158, United States
    Recruiting
    • Christina Merrick · Contactparticipate@magnetictides.com · 510-423-7125
    • Ludovica Labruna, PhD · Principal investigator
    • Richard Ivry, PhD · Principal investigator
    • Karunesh Ganguly, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Feb 2027, 4 months later.

Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 4 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

Start moved once since we started tracking on Sep 25, 2026: Jul 2026 → Oct 2026, on Sep 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2026
First posted
Jun 5, 2026
StartEst.
Oct 1, 2026was Jul 2026
Primary completionEst.
Feb 28, 2027
CompletionEst.
Aug 2028
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Jul 1, 2026→Oct 1, 2026
Sep 29, 2026
Enrollment
12→6
Sep 29, 2026
Eligibility
1 exclusion criterion edited
What changed in the criteria
Exclusion criteria
  • EditedParticipants with moderate or severe cognitive impairment (MoCAMMSE < 18).
Sep 29, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • ChangedBefore Range of Joint Motion (ROM)Now Movement Quality Index (MQI)Time frame: 6 weeks → Enrollment, then weeks 4, 6, 10, 18, 30
Sep 29, 2026
Secondary outcomes
1 edited, 1 time frame changed, 5 added, 3 removed, 1 description edited
What changed in the outcomes
  • EditedFugl- Meyer Assessment (Upper Extremity) FMA-UETime frame: 6 weeks → Enrollment, then weeks 4, 6, 10, 18, 30
  • AddedStroke Impact Scale (SIS)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
  • AddedEuroQOL (EQ-5D)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
  • AddedMotor Activity Log (MAL)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
  • AddedWolf Motor Function Test (WMFT)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
  • AddedStroke Specific QOL (SSQOL)Time frame: At enrollment, then weeks 4, 6, 10, 18, and 30
  • RemovedTransport TimeTime frame: 6 weeks
  • RemovedTrial to Trial Variability (T2TV)Time frame: 6 weeks
  • RemovedGrasp to Lift TimeTime frame: 6 weeks
  • Time frameModified Ashworth Scale (MAS)6 weeks → Enrollment, then weeks 4, 6, 10, 18, 30
  • DescriptionModified Ashworth Scale (MAS): how it is measured was reworded
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Start date Jul 1, 2026→Oct 1, 2026
    Enrollment 12→6
    Eligibility 1 exclusion criterion edited
    What changed in the criteria
    Exclusion criteria
    • EditedParticipants with moderate or severe cognitive impairment (MoCAMMSE < 18).
    Primary outcomes 1 edited
    What changed in the outcomes
    • ChangedBefore Range of Joint Motion (ROM)Now Movement Quality Index (MQI)Time frame: 6 weeks → Enrollment, then weeks 4, 6, 10, 18, 30
    Secondary outcomes 1 edited, 1 time frame changed, 5 added, 3 removed, 1 description edited
    What changed in the outcomes
    • EditedFugl- Meyer Assessment (Upper Extremity) FMA-UETime frame: 6 weeks → Enrollment, then weeks 4, 6, 10, 18, 30
    • AddedStroke Impact Scale (SIS)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
    • AddedEuroQOL (EQ-5D)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
    • AddedMotor Activity Log (MAL)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
    • AddedWolf Motor Function Test (WMFT)Time frame: Enrollment, then weeks 4, 6, 10, 18, 30
    • AddedStroke Specific QOL (SSQOL)Time frame: At enrollment, then weeks 4, 6, 10, 18, and 30
    • RemovedTransport TimeTime frame: 6 weeks
    • RemovedTrial to Trial Variability (T2TV)Time frame: 6 weeks
    • RemovedGrasp to Lift TimeTime frame: 6 weeks
    • Time frameModified Ashworth Scale (MAS)6 weeks → Enrollment, then weeks 4, 6, 10, 18, 30
    • DescriptionModified Ashworth Scale (MAS): how it is measured was reworded
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07631078
Lead sponsor
Magnetic Tides
Responsible party
Sponsor
First posted
Jun 5, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Feb 28, 2027 (estimated)
Completion
Aug 2028 (estimated)
Last update
Sep 29, 2026

Study contacts

Ludovica Labruna, PhD
Contact
participate@magnetictides.com
5104237125

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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