Disorder of ConsciousnessNCT04010838
Spinal Cord Stimulation in Patients With Disorders of Consciousness
A study testing spinal cord stimulation in people with Disorder of Consciousness and Minimally Conscious State, run by Huashan Hospital at 1 site in China.
Trial summary
Disorders of consciousness(DOC) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Disorder of Consciousness, Minimally Conscious State, Vegetative State
- What is being tested?
- spinal cord stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients ages 14 to 65 years old;
- DOC patients, including vegetative state and minimally consciousness state.
- With normal body temperature, stable vital signs, spontaneous breathing without an extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
- Written informed consent from patient families
Who cannot join
- History of nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- With contraindications of spinal cord operations.
- Body temperature is abnormal, vital signs are not stable, still need a ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Huashan Hospital
Shanghai, Shanghai Municipality, 200000
Xuehai Wu, Ph.D., +8613764880571, wuxuehai2013@163.com
About this study
Official title: Effectiveness Research for Severe Disorders of Consciousness Patients Treated With Spinal Cord Stimulation (SCS)
Disorders of consciousness(DOC) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Spinal cord stimulation(SCS) for wake-promoting therapy has aroused scholars' attention and become a hot area recently. There was much debate about the effectiveness of SCS therapy, but because of the limitation of our understanding of consciousness and the uncertainty of parameters of the stimulation, So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
Read the detailed description
The spinal cord stimulation therapy is explorative at best at the moment. Attempts to improve the level of consciousness of patients in the different stages of DOC have shown some promise. Spinal cord stimulation(SCS) seem promising in some studies, suggesting that further research is needed. Current publications of DOC spinal cord stimulation therapy was not convincing because of the small number of patients and no randomized controlled trial. Therefore, there was much debate about the effectiveness of spinal cord stimulation therapy because of the limitation of our understanding of consciousness and the uncertainty of parameters of neuromodulation. The better understanding of brain function and large randomized trials are necessary. Future research should also focus on identifying specific neuro-biomarkers (i.e. neural network). So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
Scientific Issues Targeted:1) To figure out the effectiveness of spinal cord stimulation therapy using random controlled trial. 2) To explore individual parameters of SCS techniques.
- Being tested
- spinal cord stimulation
- Keywords
- disorders of consciousness, spinal cord stimulation, DoC, SCS
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord stimulationProcedure or surgery
The spinal cord stimulation(SCS) is a type of implantable neuromodulation device (spinal cord stimulator) that is used to send electrical signals to select areas of the spinal cord (C2-C4 in this study) for the treatment of disorders of consciousness.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | No intervention | Not described |
| Spinal cord stimulation and conventional treatment | Experimental | Not described Receives: Procedure: spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the JFK Coma Recovery Scale-Revised (CRS-R) scale
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
Measured: at baseline (T0), which means 1 month before stimulation.
the JFK Coma Recovery Scale-Revised (CRS-R) scale
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
Measured: 2 weeks after the end of the treatment (T1)
the JFK Coma Recovery Scale-Revised (CRS-R) scale
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
Measured: 3 months after the end of the treatment (T2)
the JFK Coma Recovery Scale-Revised (CRS-R) scale
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
Measured: 6 months after the end of the treatment(T3)
Secondary outcomes (4)
EEG recording in resting state with Phase Coherence analysis(PC index)
EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2
Measured: at baseline (T0), which means 1 month before stimulation.
EEG recording in resting state with Phase Coherence analysis(PC index)
EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2
Measured: 2 weeks after the end of the treatment (T1)
EEG recording in resting state with Phase Coherence analysis(PC index)
EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2
Measured: 3 months after the end of the treatment (T2)
EEG recording in resting state with Phase Coherence analysis(PC index)
EEG data will be collected using a 256-channel EEG recording system(GES300, Electrical Geodesic, Inc., USA). Phase Coherence index will be performed in MATLAB by first taking the phase of the spectral signals(A), and the caculating as the following: mean[cos(A),2]^2 + mean[sin(A),2]^2
Measured: 6 months after the end of the treatment (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of ConsciousnessStudies of the same condition, open and under way.
- More trials run by Huashan 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
- Model description
- Random controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehai Wu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010838
- Sponsor's protocol ID
- KY2017-329
- Status last verified
- Jul 2019
- First submitted
- 18 May 2019
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Research for Severe Disorders of Consciousness Patients Treated With Spinal Cord Stimulation (SCS)
- ClinicalTrials.gov ID
- NCT04010838
- Acronym / sponsor ID
- KY2017-329
- Keywords
- disorders of consciousness, spinal cord stimulation, DoC, SCS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Jul 2019 (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) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Spinal cord stimulation(SCS) for wake-promoting therapy has aroused scholars' attention and become a hot area recently. There was much debate about the effectiveness of SCS therapy, but because of the limitation of our understanding of consciousness and the uncertainty of parameters of the stimulation, So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
Detailed description
The spinal cord stimulation therapy is explorative at best at the moment. Attempts to improve the level of consciousness of patients in the different stages of DOC have shown some promise. Spinal cord stimulation(SCS) seem promising in some studies, suggesting that further research is needed. Current publications of DOC spinal cord stimulation therapy was not convincing because of the small number of patients and no randomized controlled trial. Therefore, there was much debate about the effectiveness of spinal cord stimulation therapy because of the limitation of our understanding of consciousness and the uncertainty of parameters of neuromodulation. The better understanding of brain function and large randomized trials are necessary. Future research should also focus on identifying specific neuro-biomarkers (i.e. neural network). So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.
Scientific Issues Targeted:1) To figure out the effectiveness of spinal cord stimulation therapy using random controlled trial. 2) To explore individual parameters of SCS techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Random controlled trial
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | No intervention | – |
| Spinal cord stimulation and conventional treatment | Experimental | Procedure: spinal cord stimulation |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ages 14 to 65 years old;
- DOC patients, including vegetative state and minimally consciousness state.
- With normal body temperature, stable vital signs, spontaneous breathing without an extra oxygen supply, no tracheotomy using metal trachea cannula, and feasible for magnetic resonance inspectors;
- Written informed consent from patient families
Key exclusion criteria (3 listed)
- History of nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- With contraindications of spinal cord operations.
- Body temperature is abnormal, vital signs are not stable, still need a ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
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 |
|---|---|---|
| spinal cord stimulationThe spinal cord stimulation(SCS) is a type of implantable neuromodulation device (spinal cord stimulator) that is used to send electrical signals to select areas of the spinal cord (C2-C4 in this study) for the treatment of disorders of consciousness. | Procedure or surgery | Spinal cord stimulation and conventional treatment |
Primary outcome
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time frame: at baseline (T0), which means 1 month before stimulation.
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time frame: 2 weeks after the end of the treatment (T1)
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time frame: 3 months after the end of the treatment (T2)
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
the JFK Coma Recovery Scale-Revised (CRS-R) scale
Time frame: 6 months after the end of the treatment(T3)
The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.
4 secondary outcomes
EEG recording in resting state with Phase Coherence analysis(PC index)
Time frame: at baseline (T0), which means 1 month before stimulation.
EEG recording in resting state with Phase Coherence analysis(PC index)
Time frame: 2 weeks after the end of the treatment (T1)
EEG recording in resting state with Phase Coherence analysis(PC index)
Time frame: 3 months after the end of the treatment (T2)
EEG recording in resting state with Phase Coherence analysis(PC index)
Time frame: 6 months after the end of the treatment (T3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2019.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal cord stimulation in people with Disorder of Consciousness and Minimally Conscious State, run by Huashan 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 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuehai Wu, Ph.D. (+8613764880571, wuxuehai2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the JFK Coma Recovery Scale-Revised (CRS-R) scale (time frame: at baseline (T0), which means 1 month before stimulation.). The study lists 4 primary outcomes in all. 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 8 Jul 2019.