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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Coma
• Intervention / Treatment: Device: SCS; Other: Conventional

• Study Type: Interventional
• Enrollment (Estimated): 344
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yong Cao, MD; Phone Number: +8613601362306; Email: caoyong@bjtth.org
• Study Contact Backup: Name: Qiheng He, MD; Phone Number: +8615699952258; Email: heqiheng96@mail.ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital, Capital Medical University
      • Contact: Yong Cao, M.D.; Phone Number: 100050 010-67096523; Email: caoyong6@hotmail.com
      • Principal Investigator: Yong Cao, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: SCS; 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.	Other: Conventional; Routine brain resuscitation and rehabilitation awakening treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glasgow Coma Scale (GCS)	Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.	12 months
National Institute of Health stroke scale (NIHSS)	Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.	12 months
Full Outline of UnResponsiveness (FOUR) Score	Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.	12 months
Disability rating scale (DRS)	Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.	12 months

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids; Shenzhen Qianhai Shekou Free Trade Zone Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2030

Study Registration Dates

• First Submitted: May 25, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage; Consciousness Disorders
• Other Study ID Numbers: 2022GKZS0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No