StrokePhase 3NCT02006875
rTMS Study to Improve Functional Performance for Patients With Stroke
A Phase 3 study testing rTMS in people with Stroke, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- 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
- Jan 2013to Dec 2015
- Phase
- Phase 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral hemiplegia caused by the stroke,
- first ever stroke,
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- Functional ambulation classification (FAC): 0-2,
Who cannot join
- contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
- cranial metal implants
- intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
- able to complete Timed Up and Go (TUG) test within 2 minutes
- unable to walk normally before the stroke
- those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
Read the detailed description
Protocol:
- Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
- Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
- Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
- Study design: controlled trial with stratified randomization
- Blinding
- The patients were blinded by the real or sham coil of rTMS
- The assessors who performed the outcome measurements were blinded to the assignment of treatment.
- Measurements.
- Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention.
- Clinical assessments.
- Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS)
- The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
- The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
- Timed Up and Go (TUG) test was used to assess the gross mobility.
- Barthel Index (BI) for the ADL independence
- modified Rankin Scale (MRS) for disability classification were also collected.
- These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
- Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
- Conditions
- Stroke
- Being tested
- rTMS
- Keywords
- repetitive transcranial magnetic stimulation, postural, balance, mobility, leg, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called Magstim Rapid2
Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| real rTMS | Experimental | Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins. Receives: Device: rTMS |
| sham rTMS | Sham comparator | the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG)
Measured: Up to 3 months after interventions completed
Secondary outcomes (5)
the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Measured: up to 3 months after the intervention completed
The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
Measured: up to 3 months after the interventions completed
Barthel Index (BI)
Measured: Up to 3 months after interventions completed
Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke.
Measured: up to 3 months after the intervention completed
modified Rankin Scale (MRS)
Measured: Up to 3 months after interventions completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Nung Lin, Taipei Medical University WanFang Hospital
- Investigators
- Yen-Nung Lin, MD, MS, Principal investigator, Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006875
- Sponsor's protocol ID
- 102-wf-eva-04
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lin YN, Hu CJ, Chi JY, Lin LF, Yen TH, Lin YK, Liou TH. Effects of repetitive transcranial magnetic stimulation of the unaffected hemisphere leg motor area in patients with subacute stroke and substantial leg impairment: A pilot study. J Rehabil Med. 2015 Apr;47(4):305-10. doi: 10.2340/16501977-1943.
PubMed 25679340
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02006875
- Acronym / sponsor ID
- 102-wf-eva-04
- Conditions
- Stroke
- Keywords
- repetitive transcranial magnetic stimulation, postural, balance, mobility, leg, stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 10 Dec 2013 (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.
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
Detailed description
Protocol:
- Setting: inpatient rehabilitation department of Shuang-Ho Hospital.
- Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH).
- Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH.
- Study design: controlled trial with stratified randomization
- Blinding
- The patients were blinded by the real or sham coil of rTMS
- The assessors who performed the outcome measurements were blinded to the assignment of treatment.
- Measurements.
- Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention.
- Clinical assessments.
- Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS)
- The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
- The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
- Timed Up and Go (TUG) test was used to assess the gross mobility.
- Barthel Index (BI) for the ADL independence
- modified Rankin Scale (MRS) for disability classification were also collected.
- These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements.
- Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real rTMS | Experimental | Device: rTMSExperimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins. |
| sham rTMS | Sham comparator | Device: rTMSthe control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- unilateral hemiplegia caused by the stroke,
- first ever stroke,
- time since stroke: 10-90 days,
- age: 18-80 y/o,
- Functional ambulation classification (FAC): 0-2,
Key exclusion criteria (6 listed)
- contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
- cranial metal implants
- intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
- able to complete Timed Up and Go (TUG) test within 2 minutes
- unable to walk normally before the stroke
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 Rapid2Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes. | Device | real rTMS, sham rTMS |
Primary outcome
Timed Up and Go (TUG)
Time frame: Up to 3 months after interventions completed
5 secondary outcomes
the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Time frame: up to 3 months after the intervention completed
The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
Time frame: up to 3 months after the interventions completed
Barthel Index (BI)
Time frame: Up to 3 months after interventions completed
Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
Time frame: up to 3 months after the intervention completed
modified Rankin Scale (MRS)
Time frame: Up to 3 months after interventions completed
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 11 Dec 2015.
- Derived from this study: PubMed 25679340Lin YN, Hu CJ, Chi JY, Lin LF, Yen TH, Lin YK, Liou TH. Effects of repetitive transcranial magnetic stimulation of the unaffected hemisphere leg motor area in patients with subacute stroke and substantial leg impairment: A pilot study. J Rehabil Med. 2015 Apr;47(4):305-10. doi: 10.2340/16501977-1943.
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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.
Yen-Nung Lin, MD, MS principal investigator
Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rTMS in people with Stroke, run by Taipei Medical University WanFang Hospital 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 5 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 11 Dec 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 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.
What does this phase mean?
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 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?
Timed Up and Go (TUG) (time frame: Up to 3 months after interventions completed). 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 NCT02006875, 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 11 Dec 2015.