The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients
NCT ID: NCT02667899
Last Updated: 2019-06-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2015-11-30
2022-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DBS group
Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment.
deep brain stimulation
Deep brain stimulation means stimulate the brain with DBS.
TMS group
Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment.
transcranial magnetic stimulation
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
Control group
This Doc patients will accepted routine treatment.
Routine treatment
Means without above additional treatment.
Interventions
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deep brain stimulation
Deep brain stimulation means stimulate the brain with DBS.
transcranial magnetic stimulation
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
Routine treatment
Means without above additional treatment.
Eligibility Criteria
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Inclusion Criteria
2. DOC patients, including vegetative state and minimally consciousness state.
3. 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;
4. Written informed consent from patient families
Exclusion Criteria
2. Patients with V-P shunt or ommaya implantation, which may effects magnetic resonance scan signal analysis;
3. Body temperature is abnormal, vital signs is not stable, still need ventilator to support breathing; Plentiful sputum needed suction during MRI scans.
14 Years
65 Years
ALL
No
Sponsors
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Xuehai Wu
OTHER
Responsible Party
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Xuehai Wu
Associate Professor
Principal Investigators
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Xuehai Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Locations
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Department of Neurosurgery, Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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shwuxuehai
Identifier Type: -
Identifier Source: org_study_id
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