Pilot Study: A Novel Method of Non-Invasive Brain Stimula... | NCT06317194

Studies
Pilot Study: A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients

NCT06317194

Sponsor

Magnetic Tides

Status

Completed

Last Update Posted

Jun 30, 2026Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

kTMP

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Actual

Primary Completion Date

Apr 30, 2026Actual

Completion Date

Apr 30, 2026Actual

First Submitted Date

Mar 5, 2024

First Submission Date that Met QC Criteria

Mar 11, 2024

First Posted Date

Mar 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2026

Last Update Posted Date

Jun 30, 2026Actual

Name	Class
University of California, Berkeley	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. The goal of this proposal is to provide a first assessment of the feasibility and efficacy of an innovative non-invasive brain stimulation system, kTMP, in the treatment of motor impairment following stroke.

Detailed Description

The goal of this pilot clinical trial is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in chronic stroke patients. The kilohertz Transcranial Magnetic Perturbation (kTMP) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 V/m), something that is not possible to achieve with existing NIBS methods.

The trial also aims to assess the preliminary effects of kTMP on upper limb motor performance in individuals with chronic stroke. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate both immediate and longer-term changes in motor performance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active kTMP	Experimental	Participants receive 8 V/m of active stimulation	Device: kTMP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
kTMP	Device	A new non-invasive brain stimulation tool	Active kTMP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl- Meyer Assessment (Upper Extremity)	A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Movement smoothness of Reach-to-Grasp	Movement smoothness of the reach phase will be quantified using three-dimensional hand kinematics recorded via an electromagnetic motion capture system. Spectral Arc Length (SPARC): A frequency-domain measure of movement smoothness (Balasubramanian et al., 2015, Journal of NeuroEngineering and Rehabilitation). More negative values indicate less smooth, more fragmented movement.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age 18-80 years with stable upper limb motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to recruitment
Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50
Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP+), a proxy of residual corticospinal function.

Exclusion criteria:

Participants with cognitive impairment (MoCA < 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent.
Individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression.
Contraindications related to non-invasive brain stimulation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Magnetic Tides, Inc.		Berkeley	California	94704	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke
D000083302	Hemorrhagic Stroke
D002561	Cerebrovascular Disorders
D002493	Central Nervous System Diseases

Ancestor Terms

ID	Term
D001927	Brain Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

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Browse Branches

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