The Safety and Efficacy of Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage: a Multicenter, Prospective, Randomized, Outcome-blind Interventional Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Disorders of consciousness (DOC) refers to the persistent loss of consciousness after 28 days in patients with brain injury caused by trauma, stroke, or hypoxia. It includes coma, vegetative state, and minimally conscious state. At present, there is no effective treatment for DOC. Only one RCT study of amantadine has proved that it may be effective for the treatment of DOC. In recent years, more evidence has shown that neuromodulation technology is beneficial to the recovery of DOC. Cervical spinal cord stimulation surgery is a new treatment method for patients with DOC. Electrodes are implanted in the high cervical spinal cord C2-C5. By adjusting different electrical stimulation parameters, it has a wake-promoting effect. In this study, patients were selected into the spinal cord stimulation group and the conventional treatment group according to the wishes of their families. The patients in the spinal cord stimulation group were given 21 days of cervical spinal cord stimulation treatment on the basis of conventional brain rehabilitation. Patients were followed up routinely and completed designated examinations at 12 months to determine the safety and efficacy of cervical spinal cord stimulation therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Age between 18 and 65 years old

• Patients with postoperative consciousness disorders after cerebral hemorrhage for more than 28 days

• CRS-R score meets the MCS diagnosis

• Signed informed consent.

Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Yong Cao, MD
caoyong@bjtth.org
+8613601362306
Backup
Qiheng He, MD
heqiheng96@mail.ccmu.edu.cn
+8615699952258
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2030-09-01
Participants
Target number of participants: 344
Treatments
Experimental: Spinal cord electrical stimulation group
According to the EDC system, patients are randomly assigned to receive 21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.
Sham_comparator: Conventional treatment group
According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Shenzhen Qianhai Shekou Free Trade Zone Hospital, Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Leads: Beijing Tiantan Hospital

This content was sourced from clinicaltrials.gov