disorders of consciousness
Conditions
Interventions
Control group:Resting-state fNIRS-EEG data were collected in the control group after enrolment and at 1, 3 and 6 months of follow-up in traditional rehabilitation
GroupA:10 patients underwent GroupA stimulation parameter modulation after completion of SCS surgery: frequency 5 Hz, voltage 2 V, pulse width 210 µV, alternating ON (30 s) and OFF (3 min) of SCS, rep
GroupB:10 patients underwent GroupB stimulation parameter modulation after completion of SCS surgery: frequency 20 Hz, voltage 2 V, pulse width 210 µV, alternating ON (30 s) and OFF (3 min) of SCS, re
GroupC:10 patients underwent GroupC stimulation parameter modulation after completion of SCS surgery: frequency 70 Hz, voltage 2 V, pulse width 210 µV, alternating ON (30 s) and OFF (3 min) of SCS, re
GroupD:10 patients underwent GroupD stimulation parameter modulation after completion of SCS surgery: frequency 100 Hz, voltage 2 V, pulse width 210 µV, alternating ON (30 s) and OFF (3 min) of SCS, r
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Control group A. Meet the diagnostic criteria of chronic disorders of consciousness. B. Age 18 to 60 years old, gender is not limited. C. Consciousness disorder for 3 to 6 months. D.Cerebral cortical structures are relatively intact on at least one side of the brain, and there is no serious damage to brainstem structures. E.Normal or diminished cerebral metabolism, but the metabolism of the brainstem is essentially normal and NIR assessment is appropriate. F. No contraindications to NIR testing, no contraindications to EEG testing, and no cerebral structural abnormalities as determined by the imaging physician. G. Able to cooperate in observing adverse events and efficacy. H.Female patients with a negative pregnancy test. I.Cardiac, pulmonary, hepatic, and renal functions are essentially normal. Expected survival time: >3 months J.Written informed consent signed by the patient's legal representative. Treatment group A.Meet the diagnostic criteria of chronic disorders of consciousness and have undergone SCS implantation. B. Age 18 to 60 years old, gender is not limited. C. 3 to 6 months of impaired consciousness and failure of conventional treatment methods to promote awakening. D. Cortical structures are relatively intact on at least one side of the brain, and there is no serious damage to brainstem structures. E. Normal or diminished cerebral metabolism, but the metabolism of the brainstem is essentially normal and NIR assessment is appropriate. F. No contraindications to NIR testing, no contraindications to EEG testing, and no cerebral structural abnormalities as determined by the imaging physician. G. Able to cooperate in observing adverse events and efficacy. H.Female patients with a negative pregnancy test. I.Cardiac, pulmonary, hepatic and renal functions are essentially normal. Expected survival time: >3 months. J.Written informed consent signed by the patient's legal representative.
Exclusion criteria
Exclusion criteria: A. Patients who do not meet the diagnosis of chronic disorders of consciousness and have been ill for less than 3 months. B. Patients who have participated in other clinical trials (e.g., stem cell transplantation) within three months prior to the trial. C. Have other serious medical conditions, such as neurodegenerative diseases, or serious uncontrollable infections, such as intracranial infections. D. Patients who are otherwise unable to cooperate with the investigator, or who are determined by the investigator to be unsuitable for participation. E.Patients with cortical NIR silence (<2 µV). F.Patients or their legal representatives unable to sign the written informed consent. G. Those with sustained improvement or deterioration in consciousness within 1 month prior to enrollment. H. Those with serious complications. I.Patients with a history of severe allergies or sensitivities. J. Pregnancy, lactation. K.Patients with drug addiction, drug abuse, chronic alcoholism, and AIDS. L. Inability to cooperate in the observation of adverse events and efficacy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CRS-R ;Neurological examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxygenated haemoglobin/deoxyhaemoglobin/total haemoglobin concentrations;EEG; | — |
Countries
China
Contacts
Public ContactYi Yang
Beijing Tiantan Hospital Affiliated to Capital Medical University
Outcome results
None listed