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
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Condition or disease | Intervention/treatment | Phase |
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Coma Stroke | Device: SCS Other: Conventional | Not Applicable |
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 |
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.
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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.
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Other: Conventional
Routine brain resuscitation and rehabilitation awakening treatment. |
- 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)".
- 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)".
- Glasgow Coma Scale (GCS) [ Time Frame: 12 months ]Exploratory Indicators, ranges from 0 to 15, with higher scores mean a better outcome.
- 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.
- Full Outline of UnResponsiveness (FOUR) Score [ Time Frame: 12 months ]Exploratory Indicators, ranges from 0 to 16, with higher scores mean a better outcome.
- Disability rating scale (DRS) [ Time Frame: 12 months ]Exploratory Indicators, ranges from 0 to 29, with higher scores mean a worse outcome.
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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 |
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.
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
Contact: Yong Cao, MD | +8613601362306 | caoyong@bjtth.org | |
Contact: Qiheng He, MD | +8615699952258 | heqiheng96@mail.ccmu.edu.cn |
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. |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |