Comparing Effects of Various Combinations of 6 Hertz(Hz) rTMS & LFrTMS on Motor Recovery Due to Cerebrovascular Disease

Beijing Hospital

Status: Unknown

Conditions: Cerebrovascular Disease

Treatments: Device: all sham stimulation; Device: real primed LFrTMS at unaffected M1; Device: real LFrTMS at unaffected M1; Device: combined rTMS at both M1

Study type: Interventional

Funder types: Other

Identifiers

NCT03012204

121-2016010

Details and patient eligibility

About

To compare the effects of various combinations between 6 hertz(Hz) rTMS & LFrTMS on the limb motor dysfunction due to cerebral vascular disease.

Full description

It is the basic principle for functional recovery after cerebrovascular disease to restore the original balance in reciprocal inhibition between affected hemisphere and unaffected hemisphere.

repetitive transcranial magnetic stimulation (rTMS) is a noninvasive neuroplastic technique rebalancing interhemispheric competition after stroke. Low frequency rTMS (LFrTMS) on contralesional hemisphere or high frequency rTMS (HFrTMS) on lesional hemisphere might be the basic choice.

6 hertz(Hz) primed LFrTMS on lesional primary motor cortex has the stronger effect than LFrTMS alone does on one hand; the other newly-developed combination, i.e. HFrTMS on lesional primary motor cortex and LFrTMS on contralesional primary motor cortex might also be more effective than they do respectively on the other hand.

The main aim of our research is to find out which combination is better by considering both safety and efficiency.

Enrollment: 120 estimated patients

Sex: All

Ages: 30 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged from 30 to 90 years;
• Newly onset cerebral infarction or brain hemorrhage confirmed by MRI or CT;
• the disease duration is less than 20 weeks when recruited into the trial;
• no existence of limb motor dysfunction before this onset, and new occurrence of unilateral limb motor dysfunction after this onset;
• the physical and mental condition are good enough to cooperate with the assessment and treatment;
• the NIHSS score: total 5-20,1a,1b,1c=0;
• the subject or legal guardian sign the consent form.

Exclusion criteria

• during pregnancy;
• with skull defect;
• with metal implants, cardiac pacemaker, cochlear implantation;
• epileptiform discharge in EEG.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

combined rTMS at both M1

Experimental group

Description:

combined rTMS at both M1: sham 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / real 6 Hz rTMS on affected M1

Treatment:

Device: combined rTMS at both M1

real primed LFrTMS at unaffected M1

Experimental group

Description:

real primed LFrTMS at unaffected M1: real 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / sham 6 Hz rTMS on affected M1

Treatment:

Device: real primed LFrTMS at unaffected M1

real LFrTMS at unaffected M1

Active Comparator group

Description:

real LFrTMS at unaffected M1: sham 6 hertz(Hz) rTMS on unaffected M1 / real 1 Hz rTMS on unaffected M1 / sham 6 Hz rTMS on affected M1

Treatment:

Device: real LFrTMS at unaffected M1

all sham stimulation

Sham Comparator group

Description:

all sham stimulation： sham 6 hertz(Hz) rTMS on unaffected M1 / sham 1 Hz rTMS on unaffected M1 /sham 6 Hz rTMS on affected M1

Treatment:

Device: all sham stimulation