Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke

NCT07681102 | Enrolling By Invitation FDA Device

• 1 other identifier: Magnetic Tides Inc
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

ktmp; motor rehabilitation; ischemic stroke; hemorrhagic stroke; cerebrovascular disease; cortical excitability; plasticity; neuroscience; stroke; central nervous system disease; kilohertz transcranial magnetic perturbation

Outcome Measures

Primary Outcomes (1)

• Reach-to-grasp (Range of Motion)

  Defined as the standard deviation of the joint angle time series for a given trial. The average will be computed over a set of 15 trials.

  3 weeks

Secondary Outcomes (2)

• Fugl- Meyer Assessment (Upper Extremity)

  3 weeks

• Modified Ashworth Scale (MAS)

  3-weeks

Study Arms (2)

Stimulation Condition A

EXPERIMENTAL

Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude

Device: kTMP

Stimulation Condition B

EXPERIMENTAL

Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude

Device: kTMP

Interventions

kTMP DEVICE

A new non-invasive brain stimulation tool

Stimulation Condition A; Stimulation Condition B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-80 years who have a history of a unilateral stroke ≥ 12 m prior to enrollment.
• Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-55.
• 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 ≥ 2/4).
• 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 assessments/testing through the last visit.
• Severe spasticity of the affected upper limb (Modified Ashworth ≥ 3).
• Absolute contraindications related to non-invasive brain stimulation, including:
• History of seizures in the last 12 months while taking anti-epilepsy medication 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 Permanent eye liner or head tattoos Implanted electronics such as pacemakers, defibrillators, intrathecal baclofen pumps or vagus nerve stimulator History of experiencing a serious adverse event during a previous transcranial magnetic stimulation (TMS) session

Sponsors & Collaborators

• Magnetic Tides: lead
• University of California, Berkeley: collaborator

Study Sites (1)

Magnetic Tides Inc.

Berkeley, California, 94704, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Cerebrovascular Disorders; Central Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants complete an intake session in Week 1, followed by three days of Frequency Condition A in Week 2. Week 3 serves as a washout period, after which participants complete three days of Frequency Condition B in Week 4. Assessments are administered throughout each condition.

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): June 26, 2027
• Study Completion (Estimated): June 26, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)