Clinical trial NCT02082015: Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegia
Keywords: Neuronal plasticity
Transcranial magnetic stimulation
Stroke
Upper extremity
Function
Recovery
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: DongGuk University
name: Seoul National University Hospital
name: REMED
First posted: 2014-03-07
Enrollment: 77
Sex: ALL
Minimum age (years): 20
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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Box and Block Test (affected hand)
timeFrame: up to 17 days
Secondary outcomes:
measure: Box and Block Test (Affected and unaffected hand)
timeFrame: up to 40 days
measure: Barthel Index
timeFrame: up to 40 days
measure: National Institutes of Health Stroke Scale
timeFrame: up to 40 days
measure: Fugl-Meyer Assessment Scale
timeFrame: up to 40 days
measure: Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)
timeFrame: up to 40 days
measure: Finger tapping
timeFrame: up to 40 days
measure: B-stage (hand and arm)
timeFrame: up to 40 days
measure: Modified Ashworth scale (wrist flexor and extensor, Elbow flexor and extensor, Long finger flexor spasticity)
timeFrame: up to 40 days
Other outcomes:
measure: Vital Sign
timeFrame: up to 40 days
Locations:
city: Goyang-si
country: Korea, Republic of
facility: DongGuk University Ilsan Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
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:
citation: 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.