The effect and mechanism of intermittent theta burst stimulation combined with electroacupuncture to modulate the excitability of cortex.

Phase 1

Completed

• Conditions: Healthy subjects; Stroke

• Registration Number: ITMCTR1900002536
• Lead Sponsor: Rehabilitation College of Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Inclusion criteria for healthy subjects:
(1) aged 18 to 30 years male and female;
(2) right handedness;
(3) in good health without major diseases.
2. Inclusion criteria for stroke subjects:
(1) patients who meet the criteria for diagnosis and treatment of cerebral infarction in the 2014 edition of Chinese guidelines for diagnosis and treatment of acute ischemic stroke, and whose lesions are confirmed by craniocerebral CT or MRI examination are in the cerebral hemisphere with upper limb motor dysfunction;
(2) the onset was more than 3 months;
(3) aged 30 to 70 years male and female;
(4) right-handedness;Unilateral, first episode of cerebral infarction;
(5) primary school education or above;
(6) no severe aphasia;
(7) no cognitive impairment was found in MMSE screening;
(8) Brunnstrom II - VI;
(9) can withstand 1h detection;
(10) voluntarily participate in this study and sign the informed consent.

Exclusion Criteria

1. Exclusion criteria for healthy subjects:
(1) local skin infection, ulcer and scar;
(2) severe bleeding diseases and coagulation disorders;
(3) excessive sensitivity to acupuncture;
(4) history of epilepsy or seizure;First-degree relatives have a history of epilepsy;
(5) metal implants on the body or head above the shoulders (except in stomatology); Implanted pacemaker, defibrillator, cochlear implant, drug pump;
(6) recurrent headache of unknown cause that fails to respond to medication;
(7) skull fracture and/or severe head injury;History of head and/or brain surgery;
(8) take tricyclic antidepressants, antipsychotics, and other medications that lower the seizure threshold;
(9) history of other diseases or diseases affecting motor function;
(10) smoking and drinking;
(11) pregnancy (positive HCG test) and lactation;
(12) electrophysiological indicators: MT1mV > 60%.
2. Exclusion criteria for stroke subjects:
(1) local skin infection, ulcer and scar;
(2) severe bleeding diseases and coagulation disorders;
(3) patients with excessive sensitivity to acupuncture;
(4) history of epilepsy or seizure;First-degree relatives have a history of epilepsy;
(5) metal implants on the body or head above the shoulders (except oral cavity); Implanted pacemaker, defibrillator, cochlear implant, drug pump;
(6) recurrent headache of unknown cause that fails to respond to medication;
(7) skull fracture and/or severe head injury, history of head and/or brain surgery;
(8) severe heart disease and increased intracranial pressure;
(9) take tricyclic antidepressants, antipsychotics, and other medications that lower the seizure threshold;
(10) history of other diseases or diseases affecting motor function;
(11) mental illness;
(12) smoking and drinking;
(13) pregnancy (positive HCG test) and lactation.

Study & Design

• Study Type: Basic Science
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
motor evoked potential (MEP);

Secondary Outcome Measures

Name	Time	Method
short intracortical inhibition (SICI);cortical silent period (CSP);intracortical facilitation (ICF);central motor conduction time;