StrokeTAMASNCT02082015
Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients
A study testing Low frequency rTMS in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 3 sites in South Korea.
Trial summary
The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia
- What is being tested?
- Low frequency rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Apr 2014to 28 Feb 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-80 yrs old
- Radiologically confirmed ischemic stroke within 90 days
- Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
- Patients received stroke treatment and on secondary prevention medication
- Written informed consent
Who cannot join
- Previous medical histories of stroke, cerebral vascular operation, seizure
- Pregnancy, Breastfeeding
- Patients with hemorrhagic stroke, traumatic brain injury
- Skin lesion in the stimulation site of scalp
- Metal implants in the body (cardiac pacemaker or aneurysm clip)
- Unable to have regular physical and occupational therapies on the affected hand
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
DongGuk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 410-773
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Hospital
Seoul, 110-744
About this study
Official title: A Randomized, Double-Blind, Sham-Controlled, Multi-center Clinical Trial to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients With Ischemic Stroke
The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.
Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.
The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.
- Conditions
- Stroke, Hemiplegia
- Being tested
- Low frequency rTMS
- Keywords
- Neuronal plasticity, Transcranial magnetic stimulation, Stroke, Upper extremity, Function, Recovery
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low frequency rTMSDevice
Also called TMS
Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
| Study group | Role | What they receive |
|---|---|---|
| true coil | Experimental | Use the true coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp Receives: Device: Low frequency rTMS |
| sham coil | Sham comparator | Use the sham coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: vertical to scalp Receives: Device: Low frequency rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block Test (affected hand)
Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS
Measured: up to 17 days
Secondary outcomes (8)
Box and Block Test (Affected and unaffected hand)
Before rTMS (baseline), 10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
Barthel Index
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
National Institutes of Health Stroke Scale
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
Fugl-Meyer Assessment Scale
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
Finger tapping
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
B-stage (hand and arm)
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)
10 days after the completion of 10 sessions of rTMS, 40 days after rTMS start
Measured: up to 40 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startApr 2014
- Primary completion23 Jan 2018
- Study completion28 Feb 2018
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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DongGuk University, Seoul National University Hospital, REMED
- Responsible party
- Principal investigator, Nam-Jong Paik, Seoul National University Bundang Hospital
- Investigators
- Nam-Jong Paik, MD, PhD, Principal investigator, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082015
- Sponsor's protocol ID
- E-1308-214-002
- Acronym
- TAMAS
- Status last verified
- Sep 2020
- First submitted
- 6 Mar 2014
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kim WS, Kwon BS, Seo HG, Park J, Paik NJ. Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial. Neurorehabil Neural Repair. 2020 Sep;34(9):856-867. doi: 10.1177/1545968320948610. Epub 2020 Aug 18.
PubMed 32807013
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sham-Controlled, Multi-center Clinical Trial to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT02082015
- Acronym / sponsor ID
- TAMAS / E-1308-214-002
- Conditions
- Stroke, Hemiplegia
- Keywords
- Neuronal plasticity, Transcranial magnetic stimulation, Stroke, Upper extremity, Function, Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- DongGuk University, Seoul National University Hospital, REMED
- Study start
- Apr 2014 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 7 Mar 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 purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper Extremity Motor Function Recovery in Patients with Ischemic Stroke
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex but exact efficacy and safety of rTMS is not well established.
Eighty four patients will be recruited and will be divided into two groups. Each group will receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low frequency (1Hz), total 1800 stimulations.
The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper extremity motor function recovery in patients with ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| true coil | Experimental | Device: Low frequency rTMSUse the true coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp |
| sham coil | Sham comparator | Device: Low frequency rTMSUse the sham coil / Low frequency rTMS / Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: vertical to scalp |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 20-80 yrs old
- Radiologically confirmed ischemic stroke within 90 days
- Brunnström stage 3-5 in the affected hand (ischemic stroke-induced hemiplegic side)
- Patients received stroke treatment and on secondary prevention medication
- Written informed consent
Key exclusion criteria (6 listed)
- Previous medical histories of stroke, cerebral vascular operation, seizure
- Pregnancy, Breastfeeding
- Patients with hemorrhagic stroke, traumatic brain injury
- Skin lesion in the stimulation site of scalp
- Metal implants in the body (cardiac pacemaker or aneurysm clip)
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 |
|---|---|---|
| Low frequency rTMSAlso: TMSIntensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp | Device | sham coil, true coil |
Primary outcome
Box and Block Test (affected hand)
Time frame: up to 17 days
Before rTMS (baseline) and 10 days after the completion of 10 sessions of rTMS
8 secondary outcomes
Box and Block Test (Affected and unaffected hand)
Time frame: up to 40 days
Barthel Index
Time frame: up to 40 days
National Institutes of Health Stroke Scale
Time frame: up to 40 days
Fugl-Meyer Assessment Scale
Time frame: up to 40 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Time frame: up to 40 days
Finger tapping
Time frame: up to 40 days
B-stage (hand and arm)
Time frame: up to 40 days
Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)
Time frame: up to 40 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 9 Sep 2020.
- Derived from this study: PubMed 32807013Kim WS, Kwon BS, Seo HG, Park J, Paik NJ. Low-Frequency Repetitive Transcranial Magnetic Stimulation Over Contralesional Motor Cortex for Motor Recovery in Subacute Ischemic Stroke: A Randomized Sham-Controlled Trial. Neurorehabil Neural Repair. 2020 Sep;34(9):856-867. doi: 10.1177/1545968320948610. Epub 2020 Aug 18.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low frequency rTMS in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 3 sites 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 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Box and Block Test (affected hand) (time frame: up to 17 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 NCT02082015, 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 9 Sep 2020.