Status:
RECRUITING
Effects of Individualized rTMS in DOC Patients
Lead Sponsor:
Qiuyou Xie
Conditions:
Disorder of Consciousness
Transcranial Magnetic Stimulation
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Background: Disorder of consciousness(DOC) is a series of arousal and cognitive disorders secondary to the most severe brain injury. Once a patient is diagnosed with a DOC, a poor prognosis is assumed...
Eligibility Criteria
Inclusion
- acquired brain injuries less than 1 year and more than 28 days in DOC;
- clinical diagnosis of DOC Disease;
- no medical history of neuropsychiatric diseases;
- no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;
- stable state of disease and vital signs;
- the families of the patients volunteered the patient to participate in the study and provided signed informed consent;
- the integrity of the individualized stimulation target cortex are verified by MRI.
Exclusion
- patients in other non-invasive or invasive neuroregulation trials;
- motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;
- uncontrolled epilepsy, seizure within 4 weeks before enrollment;
- metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.
Key Trial Info
Start Date :
July 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05187000
Start Date
July 5 2021
End Date
March 31 2025
Last Update
July 26 2024
Active Locations (1)
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1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280