HealthyNCT04019028
Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation
A study testing low frequency rTMS + Navigation System and only low frequency rTMS in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS). Read more about this study
- Who is it for?
- Ages 19 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- low frequency rTMS + Navigation System and only low frequency rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2019to 16 Aug 2019
- 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 19 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult men and women without history of central nervous system disease and abnormalities
Who cannot join
- Under 18 years old, 70 years old or older
- A person who has inserted a metal object in a skull
- A person with complete occlusion of the carotid artery
- A person with epilepsy
- Pregnant and lactating women
- Who is not eligible for the test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study
In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS).
Read the detailed description
In normal subjects,
- the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS.
- Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test
- Conditions
- Healthy
- Being tested
- low frequency rTMS + Navigation System, only low frequency rTMS, Sham low frequency rTMS + Navigation System
- Keywords
- low frequency rTMS, fNIRS, Hemodynamic Response, Non-invasive brain stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low frequency rTMS + Navigation SystemDevice
1Hz low-frequency rTMS stimulation over primary motor area using navigation system
only low frequency rTMSDevice
1Hz low-frequency rTMS stimulation over primary motor area
Sham low frequency rTMS + Navigation SystemDevice
1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system
| Study group | Role | What they receive |
|---|---|---|
| Navigated low frequency rTMS | Experimental | Application of 1Hz low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere using a navigation system.
Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image. Receives: Device: low frequency rTMS + Navigation System |
| only low frequency rTMS(not using Navigation System) | Experimental | Application of low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere not using a navigation system.
TMS coil is fixed on the target area based on MEP hotspot. Receives: Device: only low frequency rTMS |
| Navigated Sham rTMS | Sham comparator | Application of repetitive transcranial magnetic stimulation with sham mode(no stimulation) to the primary motor area of the dominant hemisphere using a navigation system.
Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image.
Sham stimulation is stimulated by the same frequency, intensity and time as the actual stimulus in such a way that the 8-shaped coil is placed at a 90 degree angle to the scalp in the same manner as rTMS and sounds are heard but the magnetic stimulus is not transmitted to the cerebrum Receives: Device: Sham low frequency rTMS + Navigation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Cortical activation
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) before and after stimulation
Measured: Baseline and after intervention[Immediately after 20 minutes of intervention]
Secondary outcomes (3)
Changes in motor evoked potentia
measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle.
Measured: Baseline and after intervention[Immediately after 20 minutes of intervention]
changes in nine hole peg test
Nine-Hole Peg Test is used to measure finger dexterity in patients with various neurological diagnoses.
Measured: Baseline and after intervention[Immediately after 20 minutes of intervention]
Sequential motor task
It is a training exercise in which five digits are repeatedly pressed with five fingers using individual movements, and it is trained to press the button accurately and quickly.
Measured: Baseline and after intervention[Immediately after 20 minutes of intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start12 Jul 2019
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
- Investigators
- Yun-Hee Kimm, MD, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019028
- Sponsor's protocol ID
- 2014-05-021
- Status last verified
- Feb 2020
- First submitted
- 11 Jul 2019
- Last updated
- 27 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Monitoring of Motor Cortical Activity Induced by Low-frequency Repetitive Transcranial Magnetic Stimulation: Functional Near Infrared Spectroscopic Study
- ClinicalTrials.gov ID
- NCT04019028
- Acronym / sponsor ID
- 2014-05-021
- Conditions
- Healthy
- Keywords
- low frequency rTMS, fNIRS, Hemodynamic Response, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 15 Jul 2019 (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.
In this study, we investigated the effect of low-frequency repetitive trans cranial magnetic stimulation, one of the noninvasive brain stimuli, on the functional changes of the bilateral motor cortical activity in normal subjects using functional near infrared spectroscopy (fNIRS).
Detailed description
In normal subjects,
- the effect of low-frequency repetitive transcranial magnetic stimulation on cerebral cortex are measured in real time using fNIRS.
- Changes in cerebral cortical activity before and after stimulation are measured using the motor function test and the motor-induced potential test
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Navigated low frequency rTMS | Experimental | Device: low frequency rTMS + Navigation SystemApplication of 1Hz low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere using a navigation system. Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image. |
| only low frequency rTMS(not using Navigation System) | Experimental | Device: only low frequency rTMSApplication of low frequency repetitive transcranial magnetic stimulation to the primary motor area of the dominant hemisphere not using a navigation system. TMS coil is fixed on the target area based on MEP hotspot. |
| Navigated Sham rTMS | Sham comparator | Device: Sham low frequency rTMS + Navigation SystemApplication of repetitive transcranial magnetic stimulation with sham mode(no stimulation) to the primary motor area of the dominant hemisphere using a navigation system. Using the BrainSight instrument, a navigation system, the TMS coil position can be fixed on the point precise target area based on the subject's MRI image. Sham stimulation is stimulated by the same frequency, intensity and time as the actual stimulus in such a way that the 8-shaped coil is placed at a 90 degree angle to the scalp in the same manner as rTMS and sounds are heard but the magnetic stimulus is not transmitted to the cerebrum |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adult men and women without history of central nervous system disease and abnormalities
Key exclusion criteria (6 listed)
- Under 18 years old, 70 years old or older
- A person who has inserted a metal object in a skull
- A person with complete occlusion of the carotid artery
- A person with epilepsy
- Pregnant and lactating women
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 |
|---|---|---|
| low frequency rTMS + Navigation System1Hz low-frequency rTMS stimulation over primary motor area using navigation system | Device | Navigated low frequency rTMS |
| only low frequency rTMS1Hz low-frequency rTMS stimulation over primary motor area | Device | only low frequency rTMS(not using Navigation System) |
| Sham low frequency rTMS + Navigation System1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system | Device | Navigated Sham rTMS |
Primary outcome
Changes of Cortical activation
Time frame: Baseline and after intervention[Immediately after 20 minutes of intervention]
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) before and after stimulation
3 secondary outcomes
Changes in motor evoked potentia
Time frame: Baseline and after intervention[Immediately after 20 minutes of intervention]
changes in nine hole peg test
Time frame: Baseline and after intervention[Immediately after 20 minutes of intervention]
Sequential motor task
Time frame: Baseline and after intervention[Immediately after 20 minutes of intervention]
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 27 Feb 2020.
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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.
Yun-Hee Kimm, MD, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low frequency rTMS + Navigation System and only low frequency rTMS in people with Healthy, run by Samsung Medical Center at 1 site in South Korea.
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 1 inclusion and 6 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 27 Feb 2020. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Changes of Cortical activation (time frame: Baseline and after intervention[Immediately after 20 minutes of 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 27 Feb 2020.