StrokeNCT07681102
Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke
A study testing kTMP in people with Stroke, run by Magnetic Tides at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- kTMP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to 26 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 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).
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The goal of this study is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in stroke patients. This study has a crossover design comparing low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude modulation in kTMP on upper extremity kinematics 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 short-term effects of kTMP on reach-to-grasp kinematics. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate short term changes in motor performance.
- Conditions
- Stroke
- Being tested
- kTMP
- Keywords
- ktmp, motor rehabilitation, ischemic stroke, hemorrhagic stroke, cerebrovascular disease, cortical excitability, plasticity, neuroscience, stroke, central nervous system disease, kilohertz transcranial magnetic perturbation
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Cerebrovascular Disorders, Central Nervous System 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
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Condition A | Experimental | Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude Receives: Device: kTMP |
| Stimulation Condition B | Experimental | Active kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude Receives: Device: kTMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (2)
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.
Measured: 3 weeks
Modified Ashworth Scale (MAS)
Clinical tool for measuring muscle spasticity and increased muscle tone. The MAS is a 6-point scale (0, 1, 1+, 2, 3, 4) measuring spasticity from no increase in tone to rigid limbs. Higher scores indicate greater spasticity, increased muscle tone, and greater upper limb rigidity, reflecting poorer outcomes.
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start10 Feb 2026
- Primary completion26 Jun 2027 (estimated)
- Study completion26 Jun 2027 (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
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Magnetic Tides
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681102
- Sponsor's protocol ID
- Magnetic Tides Inc
- Status last verified
- Jul 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplitude Modulation Frequency Comparison in Kilohertz Transcranial Magnetic Perturbation (kTMP) for Chronic Stroke
- ClinicalTrials.gov ID
- NCT07681102
- Acronym / sponsor ID
- Magnetic Tides Inc
- Conditions
- Stroke
- Keywords
- ktmp, motor rehabilitation, ischemic stroke, hemorrhagic stroke, cerebrovascular disease, cortical excitability, plasticity, neuroscience
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Magnetic TidesIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 26 Jun 2027 (estimated)
- Study completion
- 26 Jun 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 study is to test the feasibility of a novel first-in-class non-invasive approach to enhance motor function in stroke patients. This study has a crossover design comparing low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude modulation in kTMP on upper extremity kinematics 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 short-term effects of kTMP on reach-to-grasp kinematics. kTMP stimulation is targeted to the motor hotspot for eliciting motor evoked potentials (MEPs) within motor cortex to evaluate short term changes in motor performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stimulation Condition A | Experimental | Device: kTMPActive kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude |
| Stimulation Condition B | Experimental | Device: kTMPActive kTMP: Either low-frequency (3 Hz) versus beta-frequency (13-30 Hz) amplitude |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kTMPA new non-invasive brain stimulation tool | Device | Stimulation Condition A, Stimulation Condition B |
Primary outcome
Reach-to-grasp (Range of Motion)
Time frame: 3 weeks
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.
2 secondary outcomes
Fugl- Meyer Assessment (Upper Extremity)
Time frame: 3 weeks
Modified Ashworth Scale (MAS)
Time frame: 3-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kTMP in people with Stroke, run by Magnetic Tides at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach-to-grasp (Range of Motion) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.