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A single-arm, prospective, open-label clinical study using "Odorgenetics" technology to awaken patients with disorders of consciousness

A single-arm, prospective, open-label clinical study using "Odorgenetics" technology to awaken patients with disorders of consciousness - Study on the clinical application of "Odourgenetic" technology in the awakening of patients with patients with disorders of consciousness

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076358
Enrollment
Unknown
Registered
2023-10-07
Start date
2024-07-05
Completion date
Unknown
Last updated
2025-08-25

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

Conditions

Disorders of consciousness

Interventions

treatment group:1. Gene therapy virus 2. Respiratory inhalation drugs (dipentanone)

Sponsors

Shiyan Taihe Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed diagnosis through medical history and CT scan of the head, and the patient is in a vegetative state or a persistent vegetative state for more than 3 months; 2. Aged 12-60 years; 3. Stable condition, no signs of hydrocephalus; assessed as MCS (Minimal Consciousness State) on the Coma Recovery Scale-Revised (CRS-R) for 6 revisions within 2 weeks; 4. Complete case data.

Exclusion criteria

Exclusion criteria: 1. Prior central nervous system diseases; 2. Unstable condition with coexisting infection; 3. Intolerance or non-compliance with cranial surgery treatment; 4. History of epilepsy; 5. Coexistence of brain atrophy, hydrocephalus, and presence of metallic implants or pacemakers; 6. Incomplete medical records.

Design outcomes

Primary

MeasureTime frame
score of CRS-R ;score of brainstem auditory evoked potentials;

Secondary

MeasureTime frame
renal function;The mRNA levels of residual AAV viruses in the free plasma;Content of Dipentanone in Plasma;

Countries

China

Contacts

Public ContactJie Luo

Shiyan Taihe Hospital

changbinke-iap@taihehospital.com+86 719 880 1545

Outcome results

None listed

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