Consciousness DisordersNCT02667899
The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients
A study testing deep brain stimulation, transcranial magnetic stimulation and Routine treatment in people with Consciousness Disorders, run by Xuehai Wu at 1 site in China.
Trial summary
Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients. Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Consciousness Disorders
- What is being tested?
- deep brain stimulation, transcranial magnetic stimulation and Routine treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Nov 2022
- 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 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 with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- Patients with V-P shunt or ommaya implantation, which may effects magnetic resonance scan signal analysis;
- Body temperature is abnormal, vital signs is not stable, still need 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, 200040
Xuehai Wu, PhD, +8613764880571, wuxuehai2013@163.com
About this study
Official title: The Consciousness Variation of Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) for Disorders of Consciousness(DOC) Patients in a Large Scale Randomised Trial
Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.
Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. Three months after treatments, the result will be analysed and concluded.
Read the detailed description
To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Stimulation) for DOC (Disorders of Consciousness) patients. Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. These patients will be recorded the conscious level, fMRI (functional magnetic resonance imaging) and EEG evaluation before treatment of research, and three months later the prognosis was also recorded. Finally, the variation of consciousness, prognosis, fMRI and EEG index for three groups will be analyzed and compared. Hopefully, there will be a conclusion for these treatments to DOC patients.
- Conditions
- Consciousness Disorders
- Being tested
- deep brain stimulation, transcranial magnetic stimulation, Routine treatment
- Keywords
- disorders of consciousness, deep brain stimulation, transcranial magnetic stimulation
- Medical subject headings
- Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulationDevice
Deep brain stimulation means stimulate the brain with DBS.
transcranial magnetic stimulationDevice
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
Routine treatmentOther
Means without above additional treatment.
| Study group | Role | What they receive |
|---|---|---|
| DBS group | Active comparator | Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment. Receives: Device: deep brain stimulation |
| TMS group | Active comparator | Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment. Receives: Device: transcranial magnetic stimulation |
| Control group | Placebo comparator | This Doc patients will accepted routine treatment. Receives: Other: Routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)
revised-coma recovery scale(CRS-R)
Measured: 3 months
Secondary outcomes (2)
The conscious index based on fMRI
Using fMRI to evaluate consciousness in DoC patients
Measured: 3 months
The conscious index based on EEG
Using EEG to evaluate consciousness in DoC patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2020 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisordersStudies of the same condition, open and under way.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuehai Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xuehai Wu, Huashan Hospital
- Investigators
- Xuehai Wu, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667899
- Sponsor's protocol ID
- shwuxuehai
- Status last verified
- Jun 2019
- First submitted
- 20 Dec 2015
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Ok. All participant data which can be shared will include these patient's clinical information, consciousness level and prognosis scores. Who want to share data can email to our group for data and we will glad to share.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Consciousness Variation of Deep Brain Stimulation (DBS) and Transcranial Magnetic Stimulation (TMS) for Disorders of Consciousness(DOC) Patients in a Large Scale Randomised Trial
- ClinicalTrials.gov ID
- NCT02667899
- Acronym / sponsor ID
- shwuxuehai
- Conditions
- Consciousness Disorders
- Keywords
- disorders of consciousness, deep brain stimulation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Xuehai WuUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 29 Jan 2016 (estimated)
- 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.
Aims:To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Simulation) for DOC (Disorders of Consciousness) patients.
Methods:Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. Three months after treatments, the result will be analysed and concluded.
Detailed description
To explore the consciousness stimulation role of DBS (Deep Brain Stimulation) and TMS (Transcranial Magnetic Stimulation) for DOC (Disorders of Consciousness) patients. Seventy-five DOC patients will be randomised into three groups: DBS group, TMS group and Control group. These patients will be recorded the conscious level, fMRI (functional magnetic resonance imaging) and EEG evaluation before treatment of research, and three months later the prognosis was also recorded. Finally, the variation of consciousness, prognosis, fMRI and EEG index for three groups will be analyzed and compared. Hopefully, there will be a conclusion for these treatments to DOC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBS group | Active comparator | Device: deep brain stimulationBesides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment. |
| TMS group | Active comparator | Device: transcranial magnetic stimulationBesides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment. |
| Control group | Placebo comparator | Other: Routine treatmentThis Doc patients will accepted routine treatment. |
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 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 with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
- Patients with V-P shunt or ommaya implantation, which may effects magnetic resonance scan signal analysis;
- Body temperature is abnormal, vital signs is not stable, still need 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 |
|---|---|---|
| deep brain stimulationDeep brain stimulation means stimulate the brain with DBS. | Device | DBS group |
| transcranial magnetic stimulationTranscranial magnetic stimulation means stimulate the brain with magnetic stimulation. | Device | TMS group |
| Routine treatmentMeans without above additional treatment. | Other | Control group |
Primary outcome
The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)
Time frame: 3 months
revised-coma recovery scale(CRS-R)
2 secondary outcomes
The conscious index based on fMRI
Time frame: 3 months
The conscious index based on EEG
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: Yes. Ok. All participant data which can be shared will include these patient's clinical information, consciousness level and prognosis scores. Who want to share data can email to our group for data and we will glad to share.
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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.
Xuehai Wu, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation, transcranial magnetic stimulation and Routine treatment in people with Consciousness Disorders, run by Xuehai Wu 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 27 Jun 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuehai Wu, PhD (+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 consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale) (time frame: 3 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 27 Jun 2019.