Assessment of the Efficacy of Shunt Surgery in Patients with Prolonged Disorders of Consciousness accompanied by Normal Pressure Hydrocephalus: A Randomized, Controlled, Open-Label, Single-Center, Prospective Clinical Trial

Assessment of the Efficacy of Shunt Surgery in Patients with Prolonged Disorders of Consciousness accompanied by Normal Pressure Hydrocephalus: A Randomized, Controlled, Open-Label, Single-Center, Prospective Clinical Trial - Assessment of the Efficacy of Shunt Surgery in Patients with Prolonged Disorders of Consciousness accompanied by Normal Pressure Hydrocephalus: A Randomized, Controlled, Open-Label, Single-Center, Prospective Clinical Trial

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400089521

Enrollment

Unknown

Registered

2024-09-10

Start date

2024-09-10

Completion date

Unknown

Last updated

2024-09-16

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

Conditions

Prolonged Disorders of Consciousness accompanied by Normal Pressure Hydrocephalus

Interventions

Shunt Surgery Group:Shunt Surgery (Ventriculoperitoneal Shunt or Lumbar-peritoneal Shunt)

Conservative therapy

Control group:Conservative therapy

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The family members/legal guardian of the participant voluntarily agrees to participate in this study and signs the informed consent form, demonstrating good compliance. Age between 18 and 65 years old (at the time of signing the informed consent form), gender is not specified, with an anticipated survival period of more than 6 months. Clinical symptoms, physical signs, imaging examinations, and lumbar puncture results are consistent with the diagnosis of chronic disorders of consciousness complicated by normal pressure hydrocephalus. Preoperative evaluation indicates that the body can tolerate shunt surgery. Expected conservative treatment for 6 months poses no risk to life.

Exclusion criteria

Exclusion criteria: 1. The participant has not yet stabilized and is in a critical condition with unstable vital signs. 2. There is a clear and present central nervous system infection. 3. The participant has unresolved factors affecting the level of consciousness other than the primary condition. 4. The participant has concurrent infections in other systems, such as pulmonary infection or bloodstream infection. 5. There is evidence of infection at the skin sites along the shunt pathway, including the scalp, neck, chest, and abdomen. 6. The participant has abnormal coagulation function or concurrent hematological diseases with a significant tendency towards bleeding. 7. The participant has a history of previous abdominal surgery or trauma, intraperitoneal infection, ascites, or severe abdominal adhesions. 8. Cerebrospinal fluid analysis indicates abnormally high protein content, which may lead to shunt blockage. 9. The participant has dysfunction of other organs, such as cardiac or pulmonary abnormalities, that preclude tolerance to general anesthesia surgery. 10. The participant is currently enrolled in another clinical trial. 11. Based on the investigator's judgment, the participant has comorbid conditions that pose serious risks to safety or could affect the completion of the study, or other reasons deemed unsuitable for inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Coma Recovery Scale-Revised;Glasgow Coma Scale;Complication rate;	—

Secondary

Measure	Time frame
Ventricular volume;Interstitial edema;	—

Countries

China

Contacts

Public ContactCaiqing

Tangdu hospital, Fourth Military Medical University,

tdsjwkcq@163.com+86 187 9269 0778

Outcome results

None listed

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