Study Stopped
Due to difficulty in patient recruitment
The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke
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)
1 other identifier
interventional
60
1 country
2
Brief 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 brainstem stroke
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jan 2023
Typical duration for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 10, 2022
CompletedStudy Start
First participant enrolled
January 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJanuary 12, 2026
January 1, 2026
3 years
September 7, 2022
January 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Box and Block test
Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
upto 42 days
Secondary Outcomes (8)
Box and Block test
upto 14 days
Fugl-Meyer Assessment Scale
upto 42 days
modified Barthel Index (the Korean version)
upto 42 days
National Institutes of Health Stroke Scale
upto 42 days
Finger tapping
upto 42 days
- +3 more secondary outcomes
Other Outcomes (1)
Vital sign
upto 42 days
Study Arms (2)
real rTMS
EXPERIMENTALUse the real rTMS coil
sham rTMS
SHAM COMPARATORUse the sham rTMS coil
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea
Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
Daejeon, 35015, South Korea
Related Publications (1)
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.
PMID: 37693768DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nam-Jong Paik, MD, PhD
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 10, 2022
Study Start
January 2, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
January 12, 2026
Record last verified: 2026-01