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Study on closed-loop neural regulation of central loop function in disorder of consciousness

Study on closed-loop neural regulation of central loop function in disorder of consciousness

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085855
Enrollment
Unknown
Registered
2024-06-19
Start date
2022-07-31
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disorder of consciousness

Interventions

control group:Only traditional rehabilitation treatment was performed.
DBS treatment group :The DBS Surgical Treatment and Regulation Group

Sponsors

Beijing Tiantan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of consciousness disorder; 2) 18-75 years old, regardless of gender; 3) The duration of illness must be more than 3 months, and the consciousness has not been progressively improved or deteriorated for more than 4 weeks; It is suggested that the operation time should be extended to 6 months after injury, and the patient has been unconsciously improved for 8 weeks; 4) The heart, lungs, liver and kidney functions are basically normal; 5) At least one side of the cerebral cortex structure is relatively intact, and the brain stem structure is seriously damaged; 6) Appropriate evaluation (neuroimaging, EEG, various evoked potentials); 7) Expected survival time: > 3 months; 8) can cooperate to observe adverse events and curative effects; 9) No serious surgical contraindications; 10) Imaging examination showed no moderate or above white matter lesions or multiple subcortical lacunar infarcts, no cortical lesions, and no subcortical lesions with a diameter of more than 1-5mm; 11) The pregnancy test of female patients is negative; 12) Blood coagulation function is normal; 13) The legal representative of the patient signs a written informed consent.

Exclusion criteria

Exclusion criteria: 1) Do not meet the diagnosis of chronic disturbance of consciousness (DOC); 2) neurodegenerative diseases, intracranial infection, and coma after brain tumor surgery; 3) The consciousness has been continuously improved or deteriorated within one month before joining the group; 4) those with serious complications; 5) Patients who have participated in other clinical trials within three months before the trial; 6) Patients with severe allergic history or allergic constitution; 7) Pregnancy and lactation; 8) Other serious medical diseases or serious uncontrollable infections; Can cooperate to observe adverse events and curative effect; 9) drug addicts, drug abusers, long-term alcoholics and AIDS patients; 10) Patients or their legal representatives cannot sign written informed consent; 11) Can't cooperate to observe adverse events and curative effect.

Design outcomes

Primary

MeasureTime frame
CRS-R scale;Scalp EEG;CM-Pf nucleus’s LFP;

Secondary

MeasureTime frame
Patient CT and MRI;Patient's blood test results;

Countries

China

Contacts

Public ContactYi Yang

Beijing Tiantan Hospital, Capital Medical University

yangyi_81nk@163.com+86 138 1096 0062

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026