Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage

Stroke Clinical Trial

— SCS-ICH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922644
• Other study ID #: 2022GKZS0005
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: September 1, 2030

Study information

• Verified date: June 2023
• Source: Beijing Tiantan Hospital
• Contact: Yong Cao, MD
• Phone: +8613601362306
• Email: caoyong[@]bjtth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 344
• Est. completion date: September 1, 2030
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Coma
• Consciousness Disorders
• Hemorrhage
• Stroke

Intervention

Device:
• SCS
21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.

Other:
• Conventional
Routine brain resuscitation and rehabilitation awakening treatment.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Qianhai Shekou Free Trade Zone Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Glasgow Coma Scale (GCS)	Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.	12 months
Other	National Institute of Health stroke scale (NIHSS)	Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.	12 months
Other	Full Outline of UnResponsiveness (FOUR) Score	Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.	12 months
Other	Disability rating scale (DRS)	Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.	12 months
Primary	Change in consciousness 12 months after surgery assessed by CRS-R	The primary efficacy indicator is "change in consciousness recovery 12 months after cervical spinal cord electrical stimulation (assessed by the Coma Recovery Scale - Revised (CRS-R), ranges from 0 to 25, with higher scores mean a better outcome)".	12 months
Secondary	Consciousness recovery 12 months after surgery assessed by GOS-E	The secondary efficacy indicator is "consciousness recovery 12 months after surgery (assessed by the Glasgow Outcome Scale - Extended (GOS-E) to evaluate the patient's consciousness status, ranges from 0 to 8, with higher scores mean a better outcome)".	12 months