The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Consciousness Disorders

Intervention / Treatment
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* Device: deep brain stimulation
* Device: transcranial magnetic stimulation
* Other: Routine treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DBS group<br>Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment. | Device: deep brain stimulation<br>* Deep brain stimulation means stimulate the brain with DBS.<br>|
| Active Comparator: TMS group<br>Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment. | Device: transcranial magnetic stimulation<br>* Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.<br>|
| Placebo Comparator: Control group<br>This Doc patients will accepted routine treatment. | Other: Routine treatment<br>* Means without above additional treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disorders of consciousness, deep brain stimulation, transcranial magnetic stimulation