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

NCT05922644 | Recruiting DMC

• 1 other identifier: 2022GKZS0005
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

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.

Conditions

Coma; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Consciousness recovery 12 months after surgery assessed by GOS-E

  12 months

Other Outcomes (4)

• Glasgow Coma Scale (GCS)

  12 months

• National Institute of Health stroke scale (NIHSS)

  12 months

• Full Outline of UnResponsiveness (FOUR) Score

  12 months

Study Arms (2)

Spinal cord electrical stimulation group

EXPERIMENTAL

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

Conventional treatment group

SHAM COMPARATOR

According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment.

Other: Conventional

Interventions

SCS DEVICE

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

Spinal cord electrical stimulation group

Conventional OTHER

Routine brain resuscitation and rehabilitation awakening treatment.

Conventional treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Coma; Stroke

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Central Study Contacts

Yong Cao, MD

CONTACT

+8613601362306; caoyong@bjtth.org

Qiheng He, MD

CONTACT

+8615699952258; heqiheng96@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 28, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)