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

Stroke Clinical Trial

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05535504
• Other study ID #: E-2205-756-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2022
• Source: Seoul National University Bundang Hospital
• Contact: Won Kee Chang, MD
• Phone: 82-031-787-7739
• Email: wonkee.chang[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 brainstem stroke

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Stem Infarctions
• Cerebral Infarction
• Hemiplegia
• Infarction
• Stroke

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea	Daejeon
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital	Seongnam-si	Korea, Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Chungnam National University Hospital, REMED

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital sign	Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Primary	Box and Block test	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Secondary	Box and Block test	Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS	upto 14 days
Secondary	Fugl-Meyer Assessment Scale	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Secondary	modified Barthel Index (the Korean version)	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Secondary	National Institutes of Health Stroke Scale	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Secondary	Finger tapping	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Secondary	Brunnstrom stage (hand and arm)	Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS	upto 42 days
Secondary	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	upto 42 days
Secondary	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	upto 42 days