HealthyNCT02932085
Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device
A study testing Neurostar TMS Therapy System, NeuroStar XPLOR System in people with Healthy, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals. Read more about this study
- Who is it for?
- Ages 19 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Neurostar TMS Therapy System, NeuroStar XPLOR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2016to Nov 2017
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 19-39 years
- Informed consent
Who cannot join
- Pregnancy or breastfeeding
- High fever patient
- Current and past history of seizure or epilepsy
- Evidence of epilepsy on EEG
- Pregnancy or possibility of pregnancy during period
- Major medical or neurological illnesses
Show all 10Show fewer
- Evidence of alcohol intake on alcohol breath test
- Contraindications to MRI scans and transcranial magnetic stimulation
- Risk of skin burns
- Use of medications that could have influenced on the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device: A Single Institution, Randomized, Double-blind, Sham-controlled Study Using Multimodal Neuroimaging in Healthy Young Adults
This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals.
Read the detailed description
The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by multimodal neuroimaging in healthy individuals.
- Conditions
- Healthy
- Being tested
- Neurostar TMS Therapy System, NeuroStar XPLOR System
- Keywords
- Transcranial magnetic stimulation, Magnetic resonance imaging, Magnetic resonance spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostar TMS Therapy System, NeuroStar XPLOR SystemDevice
Repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| rTMS + Wash-out period + Sham | Active comparator | * Five consecutive daily repetitive transcranial magnetic stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System)
* Two weeks wash-out period
* Five consecutive daily sham stimulation sessions Receives: Device: Neurostar TMS Therapy System, NeuroStar XPLOR System |
| Sham + Wash-out period + rTMS | Sham comparator | * Five consecutive daily sham stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System)
* Two weeks wash-out period
* Five consecutive daily repetitive transcranial magnetic stimulation sessions Receives: Device: Neurostar TMS Therapy System, NeuroStar XPLOR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic brain changes in magnetic resonance imaging by computational approaches
Measured: after 5 sessions (1 session/day) equals 5 days
Secondary outcomes (3)
Functional brain changes in magnetic resonance imaging by computational approaches
Measured: after 5 sessions (1 session/day) equals 5 days
Standardized scores on a neuropsychological test battery
Measured: after 5 sessions (1 session/day) equals 5 days
Analysis of EEG activity
Measured: after 5 sessions (1 session/day) equals 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionNov 2017
- Study completionNov 2017
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sujung Yoon, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932085
- Sponsor's protocol ID
- NRF_rTMS
- Status last verified
- Jul 2019
- First submitted
- 26 Sep 2016
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hong H, Kim RY, Song Y, Suh C, Lee H, Lyoo IK, Yoon S, Lim SM, Lee S. Genetic profile for dopamine signaling predicts brain functional reactivity to repetitive transcranial magnetic stimulation. Eur Arch Psychiatry Clin Neurosci. 2023 Feb;273(1):99-111. doi: 10.1007/s00406-022-01436-2. Epub 2022 Aug 11.
PubMed 35951113
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device: A Single Institution, Randomized, Double-blind, Sham-controlled Study Using Multimodal Neuroimaging in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT02932085
- Acronym / sponsor ID
- NRF_rTMS
- Conditions
- Healthy
- Keywords
- Transcranial magnetic stimulation, Magnetic resonance imaging, Magnetic resonance spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 13 Oct 2016 (estimated)
- 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.
This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals.
Detailed description
The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by multimodal neuroimaging in healthy individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS + Wash-out period + Sham | Active comparator | Device: Neurostar TMS Therapy System, NeuroStar XPLOR System* Five consecutive daily repetitive transcranial magnetic stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System) * Two weeks wash-out period * Five consecutive daily sham stimulation sessions |
| Sham + Wash-out period + rTMS | Sham comparator | Device: Neurostar TMS Therapy System, NeuroStar XPLOR System* Five consecutive daily sham stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System) * Two weeks wash-out period * Five consecutive daily repetitive transcranial magnetic stimulation sessions |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged 19-39 years
- Informed consent
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding
- High fever patient
- Current and past history of seizure or epilepsy
- Evidence of epilepsy on EEG
- Pregnancy or possibility of pregnancy during 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 |
|---|---|---|
| Neurostar TMS Therapy System, NeuroStar XPLOR SystemRepetitive transcranial magnetic stimulation | Device | Sham + Wash-out period + rTMS, rTMS + Wash-out period + Sham |
Primary outcome
Metabolic brain changes in magnetic resonance imaging by computational approaches
Time frame: after 5 sessions (1 session/day) equals 5 days
3 secondary outcomes
Functional brain changes in magnetic resonance imaging by computational approaches
Time frame: after 5 sessions (1 session/day) equals 5 days
Standardized scores on a neuropsychological test battery
Time frame: after 5 sessions (1 session/day) equals 5 days
Analysis of EEG activity
Time frame: after 5 sessions (1 session/day) equals 5 days
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 22 Jul 2019.
- Derived from this study: PubMed 35951113Hong H, Kim RY, Song Y, Suh C, Lee H, Lyoo IK, Yoon S, Lim SM, Lee S. Genetic profile for dopamine signaling predicts brain functional reactivity to repetitive transcranial magnetic stimulation. Eur Arch Psychiatry Clin Neurosci. 2023 Feb;273(1):99-111. doi: 10.1007/s00406-022-01436-2. Epub 2022 Aug 11.
- 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 Neurostar TMS Therapy System, NeuroStar XPLOR System in people with Healthy, run by Ewha Womans University Mokdong Hospital 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 2 inclusion and 10 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 22 Jul 2019. 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?
Metabolic brain changes in magnetic resonance imaging by computational approaches (time frame: after 5 sessions (1 session/day) equals 5 days). 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 NCT02932085, 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 22 Jul 2019.