ComaSCS-ICHNCT05922644
Short-term Cervical Spinal Cord Stimulation in Patients With Disorders of Consciousness After Intracerebral Hemorrhage
A study testing SCS and Conventional in people with Coma and Stroke, run by Beijing Tiantan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- SCS and Conventional
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 344 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Yong Cao, M.D., 010-67096523 ext. 100050, caoyong6@hotmail.com
Yong Cao, M.D.
About this study
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
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.
- Being tested
- SCS, Conventional
- Medical subject headings
- Coma, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCSDevice
21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment.
ConventionalOther
Routine brain resuscitation and rehabilitation awakening treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)".
Measured: 12 months
Secondary outcomes (1)
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)".
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Nanshan District Shekou People's Hospital
- Responsible party
- Principal investigator, Dr. Yong Cao, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922644
- Sponsor's protocol ID
- 2022GKZS0005
- Acronym
- SCS-ICH
- Status last verified
- Jun 2023
- First submitted
- 25 May 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05922644
- Acronym / sponsor ID
- SCS-ICH / 2022GKZS0005
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Rehabilitation Hospital Affiliated to National Research Center for Rehabilitation Technical Aids, Shenzhen Nanshan District Shekou People's Hospital
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal cord electrical stimulation group | Experimental | Device: SCSAccording 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. |
| Conventional treatment group | Sham comparator | Other: ConventionalAccording to the EDC system, patients are randomly assigned to receive only routine brain resuscitation and rehabilitation awakening treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCS21 days of cervical spinal cord electrical stimulation treatment in addition to routine brain resuscitation and rehabilitation awakening treatment. | Device | Spinal cord electrical stimulation group |
| ConventionalRoutine brain resuscitation and rehabilitation awakening treatment. | Other | Conventional treatment group |
Primary outcome
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)".
1 secondary outcome
Consciousness recovery 12 months after surgery assessed by GOS-E
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCS and Conventional in people with Coma and Stroke, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Cao, MD (+8613601362306, caoyong@bjtth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in consciousness 12 months after surgery assessed by CRS-R (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.