StrokePhase 2/3NCT01311271
Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation(rTMS) on the Recovery After Stroke
A Phase 2/3 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2011to Feb 2012
- Phase
- Phase 2/3
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- single mono-hemispheric ischemic or hemorrhagic stroke
- 1st onset stroke patient
- Upper extremity functional deficit attributable to acute stroke
- A stage of at least 3 on brunnström pre-treatment
- Written signed consent
Who cannot join
- Multiple lesion
- Bilateral cortical lesion and motor problems
- Cerebellar, or brainstem lesions
- History of more than one stroke
- Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
- Increased intracranial pressure
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- History of seizure confirmed by interview and medical chart review
- Any individual who is on medication which is known to lower seizure threshold
- Other conditions that increase the risk of side effects due to rTMS procedures: a metal plate or metal object in the skull or eye, intracardiac line, increased intracranial pressure, cardiac pacemaker, implanted medication pump, tricyclic antidepressants, neuroleptics, history of seizure in the immediate family
- An age of less than 20 years old
- Any current actively treated medical or surgical condition or neurological or psychiatric illness other than stroke
- Complications that would prevent participation in the intervention, such as severe pain and severe spasticity
- Inability to cooperate outcome measure-related task
- Severe language disturbances
- Serious cognitive deficits
- Non-vascular cause for the neurological symptoms other central nervous system
- Disorder or peripheral neuropathy of the upper extremity
- Taking medication which interrupt brain activity
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.
- Conditions
- Stroke, Hemiplegia
- Being tested
- repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- Stroke, Cerebrovascular disease, hemiplegia, Transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rTMS, rehabilitation, Upper Extremity
- Medical subject headings
- Stroke, Hemiplegia, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repetitive transcranial magnetic stimulation (rTMS)Device
Also called TAMAS
1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,
- Real: unaffected M1 hotspot
- Sham: coil perpendicular to scalp
| Study group | Role | What they receive |
|---|---|---|
| Sham rTMS-Sham rTMS | Sham comparator | Sham rTMS for 2 weeks Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| Sham rTMS-Real rTMS | Experimental | Sham rTMS in the first week and real rTMS in the second week Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
| Real rTMS-Real rTMS | Experimental | Real rTMS for 2 weeks Receives: Device: repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Fugl-Meyer Assessment scale (upper extremity)
Measured: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Secondary outcomes (1)
Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage
Measured: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
Why it stopped: Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Gyeongsang National University Hospital, Hanyang University, Seoul National University Boramae Hospital
- 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
- NCT01311271
- Sponsor's protocol ID
- E-1011-056-003
- Status last verified
- May 2015
- First submitted
- 4 Mar 2011
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Quantity of Repetitive Transcranial Magnetic Stimulation on the Recovery of Upper Motor Function After Stroke: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01311271
- Acronym / sponsor ID
- E-1011-056-003
- Conditions
- Stroke, Hemiplegia
- Keywords
- Stroke, Cerebrovascular disease, hemiplegia, Transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, rTMS, rehabilitation, Upper Extremity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Gyeongsang National University Hospital, Hanyang University, Seoul National University Boramae Hospital
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- First posted
- 9 Mar 2011 (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 aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) can modulate excitability of the brain via non-invasive methods. In that sense, rTMS has been used to treat a variety of symptoms of stroke during last two decades. Especially, improvement of upper extremity function has been proved by many studies. However, it remains uncertain about the optimum amount of rTMS.
The aim of this multicentric double blind study (randomized study) is to demonstrate the relationship between the amount of rTMS and the efficacy in the treatment of upper extremity motor deficits of stroke patients.
Fifty-seven patients will be included with written consent. After randomization, the subject will receive 3 different amount of treatment rTMS-rTMS, Sham-rTMS, Sham-Sham) in double blind methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS-Sham rTMS | Sham comparator | Device: repetitive transcranial magnetic stimulation (rTMS)Sham rTMS for 2 weeks |
| Sham rTMS-Real rTMS | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)Sham rTMS in the first week and real rTMS in the second week |
| Real rTMS-Real rTMS | Experimental | Device: repetitive transcranial magnetic stimulation (rTMS)Real rTMS for 2 weeks |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- single mono-hemispheric ischemic or hemorrhagic stroke
- 1st onset stroke patient
- Upper extremity functional deficit attributable to acute stroke
- A stage of at least 3 on brunnström pre-treatment
- Written signed consent
Key exclusion criteria (19 listed)
- Multiple lesion
- Bilateral cortical lesion and motor problems
- Cerebellar, or brainstem lesions
- History of more than one stroke
- Uncontrolled medical problems, such as: cardiopulmonary disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer, or renal disease;
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 transcranial magnetic stimulation (rTMS)Also: TAMAS1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day, * Real: unaffected M1 hotspot * Sham: coil perpendicular to scalp | Device | Real rTMS-Real rTMS, Sham rTMS-Real rTMS, Sham rTMS-Sham rTMS |
Primary outcome
Change in the Fugl-Meyer Assessment scale (upper extremity)
Time frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
1 secondary outcome
Change in grip strength, lateral pinch force, tip pinch force, Purdue pegboard test, K-MBI, mRS,and brunnström stage
Time frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up
Results and safety
The study was stopped early (reason given: Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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 Phase 2/3 study testing repetitive transcranial magnetic stimulation (rTMS) in people with Stroke and Hemiplegia, 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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 19 May 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Only two subjects have been recruited from start of the study. We decided to start the study in this topic, after revising the study protocol.). Results are not available in the source record.
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?
Change in the Fugl-Meyer Assessment scale (upper extremity) (time frame: Baseline, weekly during treatment, at 4-week follow-up,and at 12-week follow-up). 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 19 May 2015.