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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS group | Active Comparator | Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment. |
|
| TMS group | Active Comparator | Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment. |
|
| Control group | Placebo Comparator | This Doc patients will accepted routine treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation | Device | Deep brain stimulation means stimulate the brain with DBS. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The conscious index based on fMRI | Using fMRI to evaluate consciousness in DoC patients | 3 months |
| The conscious index based on EEG | Using EEG to evaluate consciousness in DoC patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuehai Wu, PhD | Contact | +8613764880571 | wuxuehai2013@163.com | |
| Ying Mao, PhD | Contact | +862152887200 | maoying@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xuehai Wu, PhD | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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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| ID | Term |
|---|---|
| D003244 | Consciousness Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D055909 | Magnetic Field Therapy |
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| transcranial magnetic stimulation |
| Device |
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation. |
|
| Routine treatment | Other | Means without above additional treatment. |
|
| 3 months |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |