StrokeEarly Phase 1NCT06543797
A Pilot Clinical Trial Study to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator
A Early Phase 1 study testing wearable rTMS in people with Stroke, run by Bundang CHA Hospital.
Trial summary
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- wearable rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2024to 31 Dec 2024
- Phase
- Early Phase 1
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 to 80 years old
- Those who are confirmed to have lesions in only one cerebral hemisphere or one brainstem on brain computed tomography (CT) or brain magnetic resonance imaging (MRI)
- Patients with subacute stroke between 2 weeks and less than 3 months after onset
- Motor function evaluation The total score is 0 to 56 points based on the FMA of the upper extremity on the affected side [1], and patients show impairment in upper extremity motor function.
- After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions.
Who cannot join
- Cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease
- Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke.
- Those with unstable conditions in the cardiovascular, digestive, respiratory, and endocrine systems, or with severe internal diseases such as signs of systemic infection, with unstable vital signs, or with poor overall health with a life expectancy of less than 1 year.
- Those with impaired cognitive ability (MMSE less than 10 points)
- If there are difficulties in conducting research
- If you have difficulty communicating
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- Other patients who are deemed difficult to participate in this study by the principal investigator.
- Patients who are participating in other therapeutic clinical studies or who have participated in other therapeutic clinical studies within the past 30 days (observational studies are not relevant)
- Exclusion criteria for repetitive transcranial magnetic stimulation
- Patients with medical devices implanted in the body (e.g. pacemaker)
- When a metal object is inserted into the skull
- If there is a wound on the skin at the attachment site
- History of epilepsy
- If you have cervical pain or musculoskeletal disease
- Pregnant and lactating women
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Single-center, Single-group, Investigator-led Exploratory Clinical Trial to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator.
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
- Conditions
- Stroke
- Being tested
- wearable rTMS
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable rTMSDevice
Application of inhibitory low-frequency rTMS on unaffected primary motor cortex by wearable rTMS
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Experimental | Not described Receives: Device: wearable rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
All types of adverse events that occurred during clinical trials
Measured: Before and after 2 weeks of intervention / Soon after every intervention
Secondary outcomes (12)
Changes of Fugl-Meyer assessment
Fugl-Meyer assessment for motor function in score
Measured: Before and after 2 weeks of intervention
Changes of manual muscle test (MMT)
Manual muscle test for strength in score
Measured: Before and after 2 weeks of intervention
Changes of box and block test (BBT)
Box and block test for gross manual dexterity in number of blocks from on compartment of a box to another of equal size within 60 seconds
Measured: Before and after 2 weeks of intervention
Changes of action research arm test (ARAT)
Action research arm test for functional ability of upper extremity in score
Measured: Before and after 2 weeks of intervention
Changes of Korean mini-mental state examination (K-MMSE)
Korean mini mental state exam for cognitive function in score
Measured: Before and after 2 weeks of intervention
Changes of Korean version of Modified Barthel Index (K-MBI)
Korean version of modified barthel index for functional status in score
Measured: Before and after 2 weeks of intervention
Changes of geriatric depression scale (GDS-d)
Geriatric depression scale for depression in scale
Measured: Before and after 2 weeks of intervention
Changes of electroencephalograpy (EEG)
Electroenchphalography is a test that measures EEG power in alpha band
Measured: Before and after 2 weeks of intervention
Changes of Evoked-potentials (EP)
Evoked potential is an electrical potential recorded from the nervous system of a human or animal following presentation of a stimulus. In this study, motor- and sensory- evoked potentials are included.
Measured: Before and after 2 weeks of intervention
Changes of motion analysis
Motion analysis with motion capture setup and data processing or streaming of patients movements. In this study, data of motion capture include kinetic and kinematic data including physiological parameter.
Measured: Before and after 2 weeks of intervention
Changes of functional near-infrared spectroscopy (fNIRS)
Funtional near-infrared spectroscopy meausures cortical activity in concentration of oxy- and deoxy-hemoglobin
Measured: Before and after 2 weeks of intervention
Changes of blood biomarker
Blood biomarker include expression of tumor necrosis factor (TNF)-a and interleukin (IL)-1b
Measured: Before and after 2 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start20 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bundang CHA Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MinYoung Kim, MD, PhD, Bundang CHA Hospital
- Investigators
- Minyoung Kim, M.D., Ph.D., Principal investigator, Bundang CHA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543797
- Sponsor's protocol ID
- 2024-01-070
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Single-group, Investigator-led Exploratory Clinical Trial to Determine the Safety of the Application of a Wearable Medical Electromagnetic Generator.
- ClinicalTrials.gov ID
- NCT06543797
- Acronym / sponsor ID
- 2024-01-070
- Conditions
- Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bundang CHA HospitalUniversity, hospital or other
- Study start
- 20 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Aug 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.
To explore the safety of applying repetitive low-frequency transcranial magnetic stimulation using a wearable medical electromagnetic generator in stroke patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Device: wearable rTMS |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 19 to 80 years old
- Those who are confirmed to have lesions in only one cerebral hemisphere or one brainstem on brain computed tomography (CT) or brain magnetic resonance imaging (MRI)
- Patients with subacute stroke between 2 weeks and less than 3 months after onset
- Motor function evaluation The total score is 0 to 56 points based on the FMA of the upper extremity on the affected side [1], and patients show impairment in upper extremity motor function.
- After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions.
Key exclusion criteria (15 listed)
- Cases accompanied by existing serious neurogenic diseases such as history of underlying stroke, brain tumor, hypoxic brain injury, epilepsy, or organic brain disease
- Cases accompanied by existing serious psychiatric diseases such as major schizophrenia, bipolar disorder, dementia, etc., that are receiving continuous drug treatment before the stroke.
- Those with unstable conditions in the cardiovascular, digestive, respiratory, and endocrine systems, or with severe internal diseases such as signs of systemic infection, with unstable vital signs, or with poor overall health with a life expectancy of less than 1 year.
- Those with impaired cognitive ability (MMSE less than 10 points)
- If there are difficulties in conducting research
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 |
|---|---|---|
| wearable rTMSApplication of inhibitory low-frequency rTMS on unaffected primary motor cortex by wearable rTMS | Device | Stroke patients |
Primary outcome
Safety
Time frame: Before and after 2 weeks of intervention / Soon after every intervention
All types of adverse events that occurred during clinical trials
12 secondary outcomes
Changes of Fugl-Meyer assessment
Time frame: Before and after 2 weeks of intervention
Changes of manual muscle test (MMT)
Time frame: Before and after 2 weeks of intervention
Changes of box and block test (BBT)
Time frame: Before and after 2 weeks of intervention
Changes of action research arm test (ARAT)
Time frame: Before and after 2 weeks of intervention
Changes of Korean mini-mental state examination (K-MMSE)
Time frame: Before and after 2 weeks of intervention
Changes of Korean version of Modified Barthel Index (K-MBI)
Time frame: Before and after 2 weeks of intervention
Changes of geriatric depression scale (GDS-d)
Time frame: Before and after 2 weeks of intervention
Changes of electroencephalograpy (EEG)
Time frame: Before and after 2 weeks of intervention
Changes of Evoked-potentials (EP)
Time frame: Before and after 2 weeks of intervention
Changes of motion analysis
Time frame: Before and after 2 weeks of intervention
Changes of functional near-infrared spectroscopy (fNIRS)
Time frame: Before and after 2 weeks of intervention
Changes of blood biomarker
Time frame: Before and after 2 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Minyoung Kim, M.D., Ph.D. principal investigator
Bundang CHA Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing wearable rTMS in people with Stroke, run by Bundang CHA Hospital.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ye Ji Jeong, BS (+82 031 780 6003 ext. 6003, a240283@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Before and after 2 weeks of intervention / Soon after every intervention). 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 9 Aug 2024.