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

Not Applicable

• Conditions: Cerebrovascular Disease
• Interventions: Device: combined rTMS at both M1; Device: all sham stimulation; Device: real LFrTMS at unaffected M1; Device: real primed LFrTMS at unaffected M1

• Registration Number: NCT03012204
• Lead Sponsor: Beijing Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-06
• Study Start: 2017-02-16
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combined rTMS at both M1	combined rTMS at both M1	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
all sham stimulation	all sham stimulation	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
real LFrTMS at unaffected M1	real LFrTMS at unaffected M1	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
real primed LFrTMS at unaffected M1	real primed LFrTMS at unaffected M1	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

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer assessment (FMA)	1) Before treatment (Baseline); 2) Change from Baseline FMA at the 1st workday after the last treatment; 3) Change from Baseline FMA at the 28th natural day after the last treatment	Score of Fugl-Meyer assessment
Simple Test for Evaluating Hand Function (STEF)	1) Before treatment (Baseline); 2) Change from Baseline STEF at the 1st workday after the last treatment; 3) Change from Baseline STEF at the 28th natural day after the last treatment	Score of Simple Test for Evaluating Hand Function

Secondary Outcome Measures

Name	Time	Method
National Institute of Health Stroke Scale (NIHSS)	1) Before treatment (Baseline); 2) Change from Baseline NIHSS at the 1st workday after the last treatment; 3) Change from Baseline NIHSS at the 28th natural day after the last treatment	Score of National Institute of Health Stroke Scale

Trial Locations

Locations (1)

Beijing Hospital, National Center of Gerontology; 🇨🇳 Beijing, Beijing, China