The Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

Not Applicable

Not yet recruiting

• Conditions: Hemiplegia; Stroke; Subcortical Infarction
• Interventions: Device: Low-frequency rTMS (experimental); Device: Low-frequency rTMS (sham comparator)

• Registration Number: NCT05535504
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-07
• Last Update Submitted: 2022-09-07
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Study Start: 2022-09-30
• Primary Completion: 2024-08-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
real rTMS	Low-frequency rTMS (experimental)	Use the real rTMS coil
sham rTMS	Low-frequency rTMS (sham comparator)	Use the sham rTMS coil

Primary Outcome Measures

Name	Time	Method
Box and Block test	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

Secondary Outcome Measures

Name	Time	Method
Box and Block test	upto 14 days	Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS
Fugl-Meyer Assessment Scale	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
modified Barthel Index (the Korean version)	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
National Institutes of Health Stroke Scale	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Finger tapping	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Brunnstrom stage (hand and arm)	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Modified Ashworth scale (wrist flexor, wrist extensor, elbow flexor, elbow extensor, and finger flexor)	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS
Grip strength (hand grip, pinch grip, lateral prehension, three jaw chuck)	upto 42 days	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

Trial Locations

Locations (2)

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of

Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea; 🇰🇷 Daejeon, Korea, Republic of