StrokeNCT06317194
Pilot Study: A Novel Method of Non-Invasive Brain Stimulation (kTMP) to Enhance Motor Function in Chronic Stroke Patients
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
- 15 Sep 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study: A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients
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 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.
- 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 |
|---|---|---|
| Active kTMP | Experimental | Participants receive 8 V/m of active stimulation Receives: Device: kTMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 8 weeks
Secondary outcomes (6)
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.
Measured: 8 weeks
Action Research Arm Test (ARAT)
A standardized assessment of functional hand motor performance measured by four basic movements used in everyday life (gross arm movement, grasp, grip and pinch). The scores range from 0 to 57. Higher score means a better arm motor status.
Measured: 8 weeks
Trial to Trial Variability (T2TV)
Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries. The median T2TV will be calculated for eleven degrees of freedom.
Measured: 8 weeks
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
Measured: 8 weeks
Grasp to Lift Time
Calculated for each of three epochs, pre, during and post
Measured: 8 weeks
Transport Time
Calculated for each of three epochs, pre, during and post
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start15 Sep 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergo a 4-week baseline observation period followed by a 4-week intervention period, with assessments collected throughout both phases.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
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
- NCT06317194
- Sponsor's protocol ID
- Magnetic Tides
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Merrick CM, Avraham G, Reber P, Thayer-Pham K, Dai F, Singh S, Luu C, O'Kidhain I, Ahmad-Ali H, Peterchev AV, Ganguly K, Sheltraw D, Ivry RB, Labruna L. A systematic assessment of safety, tolerability and blinding effectiveness of kilohertz transcranial magnetic perturbation (kTMP). J Neural Eng. 2026 Aug 12;23(4):044001. doi: 10.1088/1741-2552/ae93fc.
PubMed 42546760
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: A Novel Method of Non-Invasive Brain Stimulation (Kilohertz Transcranial Magnetic Perturbation) to Enhance Motor Function in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT06317194
- Acronym / sponsor ID
- Magnetic Tides
- Conditions
- Stroke
- Keywords
- kTMP, Motor Rehabilitation, Ischemic Stroke, Hemorrhagic Stroke, Cerebrovascular disease, Cortical Excitability, Plasticity, Neuroscience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Magnetic TidesIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Berkeley
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 19 Mar 2024 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergo a 4-week baseline observation period followed by a 4-week intervention period, with assessments collected throughout both phases.
| Arm | Type | Receives |
|---|---|---|
| Active kTMP | Experimental | Device: kTMPParticipants receive 8 V/m of active stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 | Active kTMP |
Primary outcome
Fugl- Meyer Assessment (Upper Extremity)
Time frame: 8 weeks
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.
6 secondary outcomes
Movement smoothness of Reach-to-Grasp
Time frame: 8 weeks
Action Research Arm Test (ARAT)
Time frame: 8 weeks
Trial to Trial Variability (T2TV)
Time frame: 8 weeks
Range of Joint Motion (ROM)
Time frame: 8 weeks
Grasp to Lift Time
Time frame: 8 weeks
Transport Time
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 42546760Merrick CM, Avraham G, Reber P, Thayer-Pham K, Dai F, Singh S, Luu C, O'Kidhain I, Ahmad-Ali H, Peterchev AV, Ganguly K, Sheltraw D, Ivry RB, Labruna L. A systematic assessment of safety, tolerability and blinding effectiveness of kilohertz transcranial magnetic perturbation (kTMP). J Neural Eng. 2026 Aug 12;23(4):044001. doi: 10.1088/1741-2552/ae93fc.
- 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. This study is not recruiting at the moment.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 30 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fugl- Meyer Assessment (Upper Extremity) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06317194, which also lists 1 linked publication.
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 30 Jun 2026.