Theta Burst Stimulation for Motor Recovery

National Taiwan University

Status: Enrolling

Conditions: Transcranial Magnetic Stimulation

Treatments: Device: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05613686

202204105DINB

Details and patient eligibility

About

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology. This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Full description

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technology.

High and low frequencies of rTMS could modulate the excitability of the cerebral cortex. Theta burst stimulation (TBS) has achieved a similar effect to traditional rTMS mode. Intermittent TBS (iTBS) could upregulate cortical excitability of the primary motor cortex (M1) and continuous TBS (cTBS) with inhibitory effect. Through modulating the excitability of bilateral hemispheres, rTMS could facilitate motor recovery in stroke patients.

This study will compare efficacy of different doses iTBS in combination with inhibitory rTMS on motor recovery and cortical excitability in subacute stroke patients.

Enrollment: 60 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1.Unilateral ischemic or hemorrhagic stroke
• 2.Stroke within 3 months
• 3.Medical Research Council Scale for Muscle Strength in upper limb ≤ 3
• 4.No previous stroke, seizure, dementia, Parkinson's disease or other degenerative neurological diseases.
• 5.Patient could sit over 15 minutes
• 6.Age over 20

Exclusion criteria

• 1.Previous stroke, traumatic brain injury, brain tumor
• 2.With central nervous system disease (spinal cord injury, Parkinson's disease)
• 3.Any contraindication to rTMS (seizure, alcoholism, metal implant, pacemaker)
• 4.Patients unable to cooperate the treatment
• 5.Pregnancy
• 6.Depression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

contralateral 1Hz+ipsilateral iTBS 1

Experimental group

Description:

Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 1

Treatment:

Device: repetitive transcranial magnetic stimulation

contralateral 1Hz+ipsilateral iTBS 2

Experimental group

Description:

Patients received contralateral 1 Hz and ipsilateral iTBS with protocol 2

Treatment:

Device: repetitive transcranial magnetic stimulation

contralateral 1Hz

Active Comparator group

Description:

Patients received contralateral 1 Hz and ipsilateral sham iTBS

Treatment:

Device: repetitive transcranial magnetic stimulation