StrokeNCT02120508
Functional Neuroimage in Assessment of Post-stroke Aphasia
A study testing rTMS in people with Stroke and Aphasia, run by vghtpe user at 1 site in Taiwan.
Trial summary
The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and… Read more about this study
- Who is it for?
- Ages 25 to 80 years
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Oct 2015
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aphasic stroke in chronic stage (over 3 months)
Who cannot join
- No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Po-Yi Tsai, MD, 886-228757293
About this study
Official title: Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.
Read the detailed description
2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.
- Being tested
- rTMS
- Keywords
- stroke, aphasia, rTMS, Functional MRI, Speech training
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called Magstim, Rapid2
To test the efficacy of this specific setting.
| Study group | Role | What they receive |
|---|---|---|
| 1 Hz rTMS, real | Experimental | 1 Hz rTMS over unaffected hemisphere for 15 minutes Receives: Device: rTMS |
| 1Hz rTMS, sham | Sham comparator | 1Hz sham rTMS, over unaffected hemisphere for 15 minutes Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concise Chinese Aphasia Test
Assess the linguistic skills such as conversation, expression, description, comprehension...
Measured: Before the rTMS intervention, at 2nd week, and 3rd month
Secondary outcomes (1)
Functional MRI
Measured: Before rTMS intervention, and at the day completing the rTMS treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startAug 2012
- Primary completionAug 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- vghtpe user
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Po-Yi Tsai, MD, Principal investigator, Department of physical medicine and rehabilitation, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120508
- Sponsor's protocol ID
- 201207007AC
- Status last verified
- Apr 2014
- First submitted
- 18 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tsai PY, Wang CP, Ko JS, Chung YM, Chang YW, Wang JX. The persistent and broadly modulating effect of inhibitory rTMS in nonfluent aphasic patients: a sham-controlled, double-blind study. Neurorehabil Neural Repair. 2014 Oct;28(8):779-87. doi: 10.1177/1545968314522710. Epub 2014 Feb 13.
PubMed 24526709Wang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.
PubMed 25378426
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of rTMS Application in Aphasic Patients Evaluated With fMRI
- ClinicalTrials.gov ID
- NCT02120508
- Acronym / sponsor ID
- 201207007AC
- Keywords
- stroke, aphasia, rTMS, Functional MRI, Speech training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- vghtpe userOther government
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 22 Apr 2014 (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.
The substantial efficacy and the possible mechanism of repetitive transcranial magnetic stimulation (rTMS) improving language recovery remained unclear. It is hypothesized that the rTMS was associated with increased synaptic connection and neural regeneration which can be evaluated via functional neuroimage and neurofiber imaging analysis. The effect of rTMS intervention was monitored by clinical testing and neuroimaging study.
Detailed description
2-week rTMS modulation has been proved to produce substantial clinical benefit with sham-controlled study. This trial aimed to investigate the possible mechanism and make clinical correlation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Hz rTMS, real | Experimental | Device: rTMS1 Hz rTMS over unaffected hemisphere for 15 minutes |
| 1Hz rTMS, sham | Sham comparator | Device: rTMS1Hz sham rTMS, over unaffected hemisphere for 15 minutes |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aphasic stroke in chronic stage (over 3 months)
Key exclusion criteria (1 listed)
- No seizure history, no brain surgery history, no electronic device in brain or chest, no dementia
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 |
|---|---|---|
| rTMSAlso: Magstim, Rapid2To test the efficacy of this specific setting. | Device | 1 Hz rTMS, real, 1Hz rTMS, sham |
Primary outcome
Concise Chinese Aphasia Test
Time frame: Before the rTMS intervention, at 2nd week, and 3rd month
Assess the linguistic skills such as conversation, expression, description, comprehension...
1 secondary outcome
Functional MRI
Time frame: Before rTMS intervention, and at the day completing the rTMS treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
- Background: PubMed 24526709Tsai PY, Wang CP, Ko JS, Chung YM, Chang YW, Wang JX. The persistent and broadly modulating effect of inhibitory rTMS in nonfluent aphasic patients: a sham-controlled, double-blind study. Neurorehabil Neural Repair. 2014 Oct;28(8):779-87. doi: 10.1177/1545968314522710. Epub 2014 Feb 13.
- Derived from this study: PubMed 25378426Wang CP, Hsieh CY, Tsai PY, Wang CT, Lin FG, Chan RC. Efficacy of synchronous verbal training during repetitive transcranial magnetic stimulation in patients with chronic aphasia. Stroke. 2014 Dec;45(12):3656-62. doi: 10.1161/STROKEAHA.114.007058. Epub 2014 Nov 6.
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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.
Po-Yi Tsai, MD principal investigator
Department of physical medicine and rehabilitation, Taipei Veterans General 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 rTMS in people with Stroke and Aphasia, run by vghtpe user at 1 site in Taiwan.
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 1 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 22 Apr 2014. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Yi Tsai, MD (886-228757293, pytsai@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concise Chinese Aphasia Test (time frame: Before the rTMS intervention, at 2nd week, and 3rd month). 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 NCT02120508, which also lists 2 linked publications.
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 Apr 2014.