The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Stroke Hemiplegia Subcortical Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

ALTMS-A

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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real rTMS

Use the real rTMS coil

Group Type EXPERIMENTAL

Low-frequency rTMS (experimental)

Intervention Type DEVICE

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 rTMS

Use the sham rTMS coil

Group Type SHAM_COMPARATOR

Low-frequency rTMS (sham comparator)

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No