StrokeNCT05535504
The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke
A study testing Low-frequency rTMS (experimental) in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and… Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Stroke, Hemiplegia, Subcortical Infarction
- What is being tested?
- Low-frequency rTMS (experimental)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 2 Jan 2023to 31 Dec 2025
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19-80 years old
- Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days
- Fugl-Meyer assessment scale (upper extremity) > 15
- Mini-mental status exam (the Korean version) > 14 with appropriate cognitive function
- Written informed consent
Who cannot join
- Fugl-Meyer assessment scale (wrist) < 1 or Fugl-Meyer assessment scale (hand) < 1
- Hemorrhagic stroke or traumatic brain injury
- Cerebellar stroke
- Previous history of stroke
- Traumatic brain injury
- Previous history of brain surgery
Show all 15Show fewer
- Need for intensive care due to complications associated with stroke (e.g. pneumonia, infection, hemodynamic instability)
- History of psychological or neurological diseases
- History of pain or muscular weakness of upper limbs which may interfere with rehabilitation
- History of seizure or epilepsy
- Aphasia
- Skin lesions in the stimulation site of scalp
- Intracranial metal implant
- Inability to receive regular physical or occupational therapy
- Disagreement to use contraception in women of childbearing age
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
Daejeon, 35015
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707
About this study
Official title: Multi-center, Prospective, Comparative, Randomized, Double Blind, Superior, Pivotal Study to Compare and Evaluate the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Applied With an Electromagnetic Therapy Stimulator 'ALTMS-A' for Upper-limb Motor Function Recovery With the Sham Control Group for Those Who Need Upper-limb Rehabilitation Treatment for Subcortical and Brainstem Stroke (Ischemic)
The purpose of this study is to evaluate the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke
Read the detailed description
After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement.
Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations.
The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem stroke.
- Conditions
- Stroke, Hemiplegia, Subcortical Infarction
- Being tested
- Low-frequency rTMS (experimental), Low-frequency rTMS (sham comparator)
- Keywords
- Stroke, Transcranial magnetic stimulation, Rehabilitation, Neuronal plasticity, Subcortical infarction
- Medical subject headings
- Stroke, Hemiplegia, Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-frequency rTMS (experimental)Device
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp
Low-frequency rTMS (sham comparator)Device
Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp
| Study group | Role | What they receive |
|---|---|---|
| real rTMS | Experimental | Use the real rTMS coil Receives: Device: Low-frequency rTMS (experimental) |
| sham rTMS | Sham comparator | Use the sham rTMS coil Receives: Device: Low-frequency rTMS (sham comparator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Block test
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
Secondary outcomes (8)
Box and Block test
Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS
Measured: upto 14 days
Fugl-Meyer Assessment Scale
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
modified Barthel Index (the Korean version)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
National Institutes of Health Stroke Scale
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
Finger tapping
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
Brunnstrom stage (hand and arm)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Measured: upto 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start2 Jan 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Due to difficulty in patient recruitment
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
- Model description
- ALTMS-A
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chungnam National University Hospital
- 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
- NCT05535504
- Sponsor's protocol ID
- E-2205-756-001
- Status last verified
- Jan 2026
- First submitted
- 7 Sep 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cho HM, Cha S, Sohn MK, Jee S, Chang WK, Kim WS, Paik NJ. Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial. Front Neurol. 2023 Aug 25;14:1216510. doi: 10.3389/fneur.2023.1216510. eCollection 2023.
PubMed 37693768
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Comparative, Randomized, Double Blind, Superior, Pivotal Study to Compare and Evaluate the Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation Applied With an Electromagnetic Therapy Stimulator 'ALTMS-A' for Upper-limb Motor Function Recovery With the Sham Control Group for Those Who Need Upper-limb Rehabilitation Treatment for Subcortical and Brainstem Stroke (Ischemic)
- ClinicalTrials.gov ID
- NCT05535504
- Acronym / sponsor ID
- E-2205-756-001
- Conditions
- Stroke, Hemiplegia, Subcortical Infarction
- Keywords
- Stroke, Transcranial magnetic stimulation, Rehabilitation, Neuronal plasticity, Subcortical infarction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to difficulty in patient recruitment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Chungnam National University Hospital
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Sep 2022 (actual)
- 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 the efficacy and safety of repetitive transcranial magnetic stimulation applied with an electromagnetic therapy stimulator 'ALTMS-A' for upper-limb motor function recovery with the sham control group for those who need upper-limb rehabilitation treatment for subcortical and brainstem stroke
Detailed description
After low-frequency repetitive transcranial magnetic stimulation (rTMS) over the contralesional motor cortex (M1), the score of the Box and Block test increased immediately, especially in patients without cortical involvement.
Eighty-eight patients will be recruited and divided into two groups. Each group will receive 10 sessions of the real rTMS or sham rTMS over the contralesional primary motor cortex. Each rTMS session consists of low-frequency (1Hz) 1800 stimulations.
The objective of this study is to evaluate the efficacy and safety of rTMS for upper-limb motor function in patients with subcortical and brainstem 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
- Model description
- ALTMS-A
| Arm | Type | Receives |
|---|---|---|
| real rTMS | Experimental | Device: Low-frequency rTMS (experimental)Use the real rTMS coil |
| sham rTMS | Sham comparator | Device: Low-frequency rTMS (sham comparator)Use the sham rTMS coil |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 19-80 years old
- Radiologically confirmed ischemic stroke with subcortical and brainstem lesions within 90 days
- Fugl-Meyer assessment scale (upper extremity) > 15
- Mini-mental status exam (the Korean version) > 14 with appropriate cognitive function
- Written informed consent
Key exclusion criteria (15 listed)
- Fugl-Meyer assessment scale (wrist) < 1 or Fugl-Meyer assessment scale (hand) < 1
- Hemorrhagic stroke or traumatic brain injury
- Cerebellar stroke
- Previous history of stroke
- Traumatic brain injury
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 rTMS (experimental)Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / Location: motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: tangential to scalp | Device | real rTMS |
| Low-frequency rTMS (sham comparator)Frequency: Low-frequency (1Hz) rTMS / Intensity: 100% of resting motor threshold / motor hotspot of the contralesional primary motor cortex (the first dorsal interosseous muscle) / Number of total stimuli : 1800 ; Coil orientation: vertical to scalp | Device | sham rTMS |
Primary outcome
Box and Block test
Time frame: upto 42 days
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
8 secondary outcomes
Box and Block test
Time frame: upto 14 days
Fugl-Meyer Assessment Scale
Time frame: upto 42 days
modified Barthel Index (the Korean version)
Time frame: upto 42 days
National Institutes of Health Stroke Scale
Time frame: upto 42 days
Finger tapping
Time frame: upto 42 days
Brunnstrom stage (hand and arm)
Time frame: upto 42 days
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
Time frame: upto 42 days
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
Time frame: upto 42 days
Results and safety
The study was stopped early (reason given: Due to difficulty in patient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 37693768Cho HM, Cha S, Sohn MK, Jee S, Chang WK, Kim WS, Paik NJ. Investigation of the efficacy of low-frequency repetitive transcranial magnetic stimulation on upper-limb motor recovery in subacute ischemic stroke without cortical involvement: a protocol paper for a multi-center, double-blind randomized controlled trial. Front Neurol. 2023 Aug 25;14:1216510. doi: 10.3389/fneur.2023.1216510. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
2 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 (experimental) in people with Stroke and Hemiplegia, run by Seoul National University Bundang Hospital at 2 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 15 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 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was stopped early (reason given: Due to difficulty in patient recruitment). 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?
Box and Block test (time frame: upto 42 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 NCT05535504, 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 12 Jan 2026.