NCT07631078

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable stroke

Timeline
24mo left

Started Jul 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Aug 2028

First Submitted

Initial submission to the registry

June 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

June 1, 2026

Last Update Submit

July 20, 2026

Conditions

StrokeChronic Stroke PatientsArm Weakness as a Consequence of Stroke

Keywords

kTMPIschemic StrokeHemorrhagic StrokeCortical ExcitabilityPlasticitykilohertz Transcranial Magnetic PerturbationCerebrovascular DisordersStrokeChronic StrokeTranscranial Magnetic StimulationNon-Invasive Brain StimulationBrain DisordersCentral Nervous System DisordersCardiovascular Disorders

Outcome Measures

Primary Outcomes (1)

  • Range of Joint Motion (ROM)

    defined as the standard deviation of the joint angle time series for a given trial. The median ROM will be calculated for eleven degrees of freedom and then averaged. If there are joints which appear to be compensatory, they will be removed from the analysis

    6 weeks

Secondary Outcomes (5)

  • Fugl- Meyer Assessment (Upper Extremity)

    6 weeks

  • Modified Ashworth Scale (MAS)

    6 weeks

  • Transport Time

    6 weeks

  • Trial to Trial Variability (T2TV)

    6 weeks

  • Grasp to Lift Time

    6 weeks

Study Arms (2)

Active kTMP

EXPERIMENTAL

Participants received 8 V/m of active stimulation

Device: kTMP

Sham kTMP

SHAM COMPARATOR

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

Device: Sham kTMP

Interventions

kTMPDEVICE

A new non-invasive brain stimulation tool

Active kTMP
Sham kTMPDEVICE

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

Sham kTMP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Participants with moderate or severe cognitive impairment (MoCA \< 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.
  • 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:
  • a) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Mission Bay- Sandler Neurosciences Center

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

StrokeIschemic StrokeHemorrhagic StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Nervous System DiseasesVascular Diseases

Central Study Contacts

Ludovica Labruna, PhD

CONTACT

5104237125participate@magnetictides.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 5, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 1, 2028

Last Updated

July 22, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)