search
Back to results

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

Primary Purpose

Coma, Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SCS
Conventional
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Spinal cord electrical stimulation group

Conventional treatment group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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)".

Secondary Outcome Measures

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)".

Full Information

First Posted
May 25, 2023
Last Updated
June 28, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Qianhai Shekou Free Trade Zone Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05922644
Brief Title
Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Qianhai Shekou Free Trade Zone Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coma, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
344 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal cord electrical stimulation group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment group
Arm Type
Sham Comparator
Arm Description
According to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment.
Intervention Type
Device
Intervention Name(s)
SCS
Intervention Description
21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.
Intervention Type
Other
Intervention Name(s)
Conventional
Intervention Description
Routine brain resuscitation and rehabilitation awakening treatment.
Primary Outcome Measure Information:
Title
Change in consciousness 12 months after surgery assessed by CRS-R
Description
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)".
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Consciousness recovery 12 months after surgery assessed by GOS-E
Description
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)".
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Glasgow Coma Scale (GCS)
Description
Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.
Time Frame
12 months
Title
National Institute of Health stroke scale (NIHSS)
Description
Exploratory Indicators, ranges from 0 to 42, with higher scores mean a worse outcome.
Time Frame
12 months
Title
Full Outline of UnResponsiveness (FOUR) Score
Description
Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.
Time Frame
12 months
Title
Disability rating scale (DRS)
Description
Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Cao, MD
Phone
+8613601362306
Email
caoyong@bjtth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Qiheng He, MD
Phone
+8615699952258
Email
heqiheng96@mail.ccmu.edu.cn
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.
Phone
010-67096523
Ext
100050
Email
caoyong6@hotmail.com
First Name & Middle Initial & Last Name & Degree
Yong Cao, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs