To Healthy VolunteerNCT01877161
Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
A study testing Repetitive magnetic stimulation to superior temporal gyrus and Repetitive magnetic stimulation to middle temporal gyrus in people with To Healthy Volunteer and Virtual Lesions for Aphasia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Healthy Volunteer, Virtual Lesions for Aphasia
- What is being tested?
- Repetitive magnetic stimulation to superior temporal gyrus and Repetitive magnetic stimulation to middle temporal gyrus
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2012to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fluent in Korean
- older than 18 years old
Who cannot join
- younger than 18 years old
- psychotic or psychiatric problems
- pregnant
- contraindications to MRI/fMRI
- uncooperative
- metalic implants, pacemaker or cochlear implants
- cannot perform outcome measure-related task
- known seizure history
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Bundang-gu, 463-707
About this study
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.
Read the detailed description
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.
- Conditions
- To Healthy Volunteer, Virtual Lesions for Aphasia
- Being tested
- Repetitive magnetic stimulation to superior temporal gyrus, Repetitive magnetic stimulation to middle temporal gyrus, Repetitive magnetic stimulation (Sham)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive magnetic stimulation to superior temporal gyrusDevice
Also called MagPro X100 magnetic stimulator
Repetitive magnetic stimulation to superior temporal gyrus
Repetitive magnetic stimulation to middle temporal gyrusDevice
Also called MagPro X100 magnetic stimulator
Repetitive magnetic stimulation to middle temporal gyrus
Repetitive magnetic stimulation (Sham)Device
Also called MagPro X100 magnetic stimulator
Repetitive magnetic stimulation (Sham)
| Study group | Role | What they receive |
|---|---|---|
| Middle temporal gyrus | Experimental | Repetitive magnetic stimulation to middle temporal gyrus Receives: Device: Repetitive magnetic stimulation to middle temporal gyrus |
| Control group | Sham comparator | Repetitive magnetic stimulation (Sham) Receives: Device: Repetitive magnetic stimulation (Sham) |
| Superior temporal gyrus | Experimental | Repetitive magnetic stimulation to superior temporal gyrus Receives: Device: Repetitive magnetic stimulation to superior temporal gyrus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)
Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus).
Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus.
The "reaction time post TMS - reaction time pre TMS" were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG
Measured: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startDec 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for To Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, MD, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877161
- Sponsor's protocol ID
- E-1206-158-003
- Status last verified
- Jun 2017
- First submitted
- 11 Mar 2013
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Navigated Repetitive Transcranial Magnetic Stimulation According to Post-stroke Aphasia Types
- ClinicalTrials.gov ID
- NCT01877161
- Acronym / sponsor ID
- E-1206-158-003
- Conditions
- To Healthy Volunteer, Virtual Lesions for Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Repetitive transcranial magnetic stimulation induced virtual lesions for aphasia.
Detailed description
To evaluate the effect of navigated repetitive transcranial magnetic stimulation in subjects with aphasia after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Middle temporal gyrus | Experimental | Device: Repetitive magnetic stimulation to middle temporal gyrusRepetitive magnetic stimulation to middle temporal gyrus |
| Control group | Sham comparator | Device: Repetitive magnetic stimulation (Sham)Repetitive magnetic stimulation (Sham) |
| Superior temporal gyrus | Experimental | Device: Repetitive magnetic stimulation to superior temporal gyrusRepetitive magnetic stimulation to superior temporal gyrus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fluent in Korean
- older than 18 years old
Key exclusion criteria (8 listed)
- younger than 18 years old
- psychotic or psychiatric problems
- pregnant
- contraindications to MRI/fMRI
- uncooperative
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 |
|---|---|---|
| Repetitive magnetic stimulation to superior temporal gyrusAlso: MagPro X100 magnetic stimulatorRepetitive magnetic stimulation to superior temporal gyrus | Device | Superior temporal gyrus |
| Repetitive magnetic stimulation to middle temporal gyrusAlso: MagPro X100 magnetic stimulatorRepetitive magnetic stimulation to middle temporal gyrus | Device | Middle temporal gyrus |
| Repetitive magnetic stimulation (Sham)Also: MagPro X100 magnetic stimulatorRepetitive magnetic stimulation (Sham) | Device | Control group |
Primary outcome
The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham)
Time frame: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)
Reaction time for lexical and repetition test were measured before and after the TMS stimulation at each sessions (at session 1, session 2, session 3 over MTG/STG/Sham; MTG: middle temporal gyrus, STG: superior temporal gyrus). Response times were measured via the response pad, and spoken responses were recorded via a SV-1 Voice Key apparatus. The "reaction time post TMS - reaction time pre TMS" were used for analysis.* Arm/Group Title Arm/Group Description Maximum length (999) Repetitive magnetic stimulation (rTMS) were applied over STG
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nam-Jong Paik, MD, PhD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive magnetic stimulation to superior temporal gyrus and Repetitive magnetic stimulation to middle temporal gyrus in people with To Healthy Volunteer and Virtual Lesions for Aphasia, run by Seoul National University Bundang 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 8 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 31 Jul 2017. 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?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Change of Reaction Time Between Before and After Stimulation in Each Session (MTG, STG, Sham) (time frame: change between before and after the TMS stimulation for each sessions (at session 1, session 2, session 3)). 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 31 Jul 2017.