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

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ClinicalTrials.gov Identifier: NCT05922644
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : July 3, 2023
Sponsor:
Collaborators:
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Information provided by (Responsible Party):
Dr. Yong Cao, Beijing Tiantan Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Coma Stroke Device: SCS Other: Conventional Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 344 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 1, 2023
Estimated Primary Completion Date : September 1, 2026
Estimated Study Completion Date : September 1, 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Coma

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in consciousness 12 months after surgery assessed by CRS-R [ Time Frame: 12 months ]
    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)".


Secondary Outcome Measures :
  1. Consciousness recovery 12 months after surgery assessed by GOS-E [ Time Frame: 12 months ]
    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)".


Other Outcome Measures:
  1. Glasgow Coma Scale (GCS) [ Time Frame: 12 months ]
    Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.

  2. National Institute of Health stroke scale (NIHSS) [ Time Frame: 12 months ]
    Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.

  3. Full Outline of UnResponsiveness (FOUR) Score [ Time Frame: 12 months ]
    Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.

  4. Disability rating scale (DRS) [ Time Frame: 12 months ]
    Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05922644


Contacts
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Contact: Yong Cao, MD +8613601362306 caoyong@bjtth.org
Contact: Qiheng He, MD +8615699952258 heqiheng96@mail.ccmu.edu.cn

Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Yong Cao, M.D.    010-67096523 ext 100050    caoyong6@hotmail.com   
Principal Investigator: Yong Cao, M.D.         
Sponsors and Collaborators
Beijing Tiantan Hospital
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids
Shenzhen Qianhai Shekou Free Trade Zone Hospital
More Information
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Responsible Party: Dr. Yong Cao, director, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT05922644    
Other Study ID Numbers: 2022GKZS0005
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: July 3, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Consciousness Disorders
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders