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

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05535504
• Collaborator: REMED (Other), Chungnam National University Hospital (Other)
• Enrollment: 88
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 27
• Patients Per Site: 44
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stroke; Hemiplegia; Subcortical Infarction	Device: Low-frequency rTMS (experimental); Device: Low-frequency rTMS (sham comparator)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Anticipated Study Start Date: Sep 30, 2022
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: real rTMS Use the real rTMS coil	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
Sham Comparator: sham rTMS Use the sham rTMS coil	Device: 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

Outcome Measures

Primary Outcome Measures

1. Box and Block test [upto 42 days]

   Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

Secondary Outcome Measures

1. Box and Block test [upto 14 days]

   Before rTMS (baseline) and immediately after the completion of 10 sessions of rTMS

2. Fugl-Meyer Assessment Scale [upto 42 days]

   Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

3. modified Barthel Index (the Korean version) [upto 42 days]

   Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

4. National Institutes of Health Stroke Scale [upto 42 days]

   Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

5. Finger tapping [upto 42 days]

   Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

6. Brunnstrom stage (hand and arm) [upto 42 days]

   Before rTMS (baseline) and 4 weeks after the completion of 10 sessions of rTMS

7. 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

8. 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

Other Outcome Measures

1. Vital sign [upto 42 days]

   Before rTMS (baseline), immediately after the completion of 10 sessions of rTMS, and 4 weeks after the completion of 10 sessions of rTMS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital	Seongnam-si	Korea, Gyeonggi-do	Korea, Republic of	463-707
2	Department of Rehabilitation Medicine, Chungnam National University Hospital, Korea	Daejeon		Korea, Republic of	35015

Sponsors and Collaborators

• Seoul National University Bundang Hospital
• REMED
• Chungnam National University Hospital

Investigators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT05535504
• Other Study ID Numbers: E-2205-756-001
• First Posted: Sep 10, 2022
• Last Update Posted: Sep 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Seoul National University Bundang Hospital: Stroke; Transcranial magnetic stimulation; Rehabilitation; Neuronal plasticity; Subcortical infarction
• Additional relevant MeSH terms: Stroke; Hemiplegia; Brain Stem Infarctions; Cerebral Infarction; Infarction

Study Results

No Results Posted as of Sep 10, 2022