Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage
Launched by BEIJING TIANTAN HOSPITAL · Jun 19, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new treatment for patients who have lost consciousness for a long time after a brain injury, such as a stroke. This condition is known as a disorder of consciousness and includes states like coma or minimally conscious state. Currently, there are very few treatment options available, and the researchers are exploring the use of cervical spinal cord stimulation, which involves placing small electrodes in the neck area to stimulate the spinal cord. The goal is to see if this treatment can help wake patients up or improve their awareness over a period of 21 days, alongside standard rehabilitation.
To participate in this trial, individuals need to be between 18 and 65 years old and have experienced a loss of consciousness for more than 28 days after a brain hemorrhage. They must also meet specific criteria indicating they are in a minimally conscious state. Participants will be divided into two groups: one receiving spinal cord stimulation and the other receiving standard treatment. Throughout the study, their progress will be monitored for up to 12 months to assess the safety and effectiveness of the stimulation therapy. It’s important to note that some medical conditions may prevent individuals from participating, such as severe brain injuries or unstable health conditions.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • Secondary brain injury caused by arteriovenous malformation, cerebral aneurysm, cavernous hemangioma, brain tumor and carbon monoxide poisoning
- • History of previous epileptic seizures
- • Critical condition, unstable intracranial condition, risk of rebleeding
- • Unstable vital signs requiring mechanical ventilation
- • Contraindications for spinal cord surgery
- • Severe sympathetic overactivity syndrome.
About Beijing Tiantan Hospital
Beijing Tiantan Hospital, affiliated with Capital Medical University, is a leading medical institution in China renowned for its expertise in neurology, neurosurgery, and various other specialties. As a prominent clinical trial sponsor, the hospital is committed to advancing medical research and improving patient outcomes through innovative studies. With a focus on high-quality clinical trials, Beijing Tiantan Hospital adheres to rigorous ethical standards and regulatory requirements, fostering collaboration with academic institutions and industry partners to facilitate the development of cutting-edge therapies and interventions. Its state-of-the-art facilities and experienced research team enable the hospital to play a pivotal role in the global medical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Beijing, Beijing, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported