Clinical trial NCT05535504: The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Hemiplegia
Subcortical Infarction
Keywords: Stroke
Transcranial magnetic stimulation
Rehabilitation
Neuronal plasticity
Subcortical infarction
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: REMED
name: Chungnam National University Hospital
First posted: 2022-09-10
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Box and Block test
timeFrame: upto 42 days
Secondary outcomes:
measure: Box and Block test
timeFrame: upto 14 days
measure: Fugl-Meyer Assessment Scale
timeFrame: upto 42 days
measure: modified Barthel Index (the Korean version)
timeFrame: upto 42 days
measure: National Institutes of Health Stroke Scale
timeFrame: upto 42 days
measure: Finger tapping
timeFrame: upto 42 days
measure: Brunnstrom stage (hand and arm)
timeFrame: upto 42 days
measure: Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)
timeFrame: upto 42 days
measure: Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
timeFrame: upto 42 days
Other outcomes:
measure: Vital sign
timeFrame: upto 42 days
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
state: Korea, Gyeonggi-do
city: Daejeon
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea
Study officials:
affiliation: Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
name: Nam-Jong Paik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: