Disorders of consciousness
Conditions
Interventions
group 1:phase I: rTMS-active
phase II: rTMS-sham
group 2:phase I: rTMS-sham
phase II: rTMS-active
Sponsors
Department of Rehabilitation,Zhujiang Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Acquired brain injuries less than 1 year and more than 28 days in DOC; 2.No medical history of neuropsychiatric diseases; 3.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; 4.Stable state of disease and vital signs; 5.The families of the patients volunteered the patient to participate in the study and provided signed informed consent; 6.The integrity of the individualized stimulation target cortex are verified by MRI.Exclusion criteria.
Exclusion criteria
Exclusion criteria: 1.Patients in other non-invasive or invasive neuroregulation trials; 2.Motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse; 3.Uncontrolled epilepsy, seizure within 4 weeks before enrollment; 4.Metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coma Recovery Scale Revised; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relative power spectral of rest-EEG;functional connectivity of rest-EEG;TMS evoked potential;global mean field amplitude;To evaluate the safety of rTMS in DoC patients.; | — |
Countries
China
Contacts
Public ContactQiuyou Xie
Zhujiang Hospital of Southern Medical University
Outcome results
None listed