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

Seoul National University

Status: Terminated

Conditions: Stroke; Subcortical Infarction; Hemiplegia

Treatments: Device: Low-frequency rTMS (sham comparator); Device: Low-frequency rTMS (experimental)

Study type: Interventional

Funder types: Other

Identifiers

NCT05535504

E-2205-756-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

real rTMS

Experimental group

Description:

Use the real rTMS coil

Treatment:

Device: Low-frequency rTMS (experimental)

sham rTMS

Sham Comparator group

Description:

Use the sham rTMS coil

Treatment:

Device: Low-frequency rTMS (sham comparator)