Effect of Cerebral and Cerebellar rTMS in Stroke Patient

Samsung Medical Center

Status: Completed

Conditions: Motor Recovery; Stroke; rTMS; Repetitive Transcranial Magnetic Stimulation

Treatments: Procedure: Repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04570774

2020-06-068

Details and patient eligibility

About

This study is based on the characteristics of motor learning theory and motor learning neural network to improve motor function in stroke patients. This study is to investigate whether the cerebral-cerebellar repetitive transcranial magnetic stimulation (rTMS) is effective in improving motor function compared to the conventional cerebral rTMS in stroke patients.

Enrollment: 56 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemiplegic stroke patients within 1 month after onset
• Moderate to severe motor impairment (Fugl-Meyer assessment <85)
• Cognitive and language functions to perform more than one step of command
• More than 19 years old

Exclusion criteria

• Contraindicated to rTMS
• Progressive or unstable stroke
• Pre-existing and active major neurological disease or major psychiatric disease
• A history of advanced liver, kidney, cardiac or pulmonary disease, a terminal medical diagnosis consistent with survival <1 year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 4 patient groups

Facilitatory cerebral and cerebellar rTMS group

Experimental group

Description:

Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere.

Treatment:

Procedure: Repetitive transcranial magnetic stimulation

Facilitatory cerebral rTMS group

Active Comparator group

Description:

Patients underwent 10 consecutive daily sessions of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the affected primary motor cortex of the hand and sham high-frequency rTMS over the ipsilateral cerebellar hemisphere.

Treatment:

Procedure: Repetitive transcranial magnetic stimulation

Inhibitory cerebral and cerebellar rTMS group

Experimental group

Description:

Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and high-frequency rTMS over the ipsilateral cerebellar hemisphere.

Treatment:

Procedure: Repetitive transcranial magnetic stimulation

Inhibitory cerebral rTMS group

Active Comparator group

Description:

Patients underwent 10 consecutive daily sessions of continous theta bust stimulation (cTBS) over the unaffected primary motor cortex of the hand and sham rTMS over the ipsilateral cerebellar hemisphere.

Treatment:

Procedure: Repetitive transcranial magnetic stimulation