The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients
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|ClinicalTrials.gov Identifier: NCT02667899|
Recruitment Status : Recruiting
First Posted : January 29, 2016
Last Update Posted : June 27, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Consciousness Disorders||Device: deep brain stimulation Device: transcranial magnetic stimulation Other: Routine treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2022|
Active Comparator: DBS group
Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment.
Device: deep brain stimulation
Deep brain stimulation means stimulate the brain with DBS.
Active Comparator: TMS group
Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment.
Device: transcranial magnetic stimulation
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
Placebo Comparator: Control group
This Doc patients will accepted routine treatment.
Other: Routine treatment
Means without above additional treatment.
- 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)
- The conscious index based on fMRI [ Time Frame: 3 months ]Using fMRI to evaluate consciousness in DoC patients
- The conscious index based on EEG [ Time Frame: 3 months ]Using EEG to evaluate consciousness in DoC patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667899
|Contact: Xuehai Wu, PhDfirstname.lastname@example.org|
|Contact: Ying Mao, PhDemail@example.com|
|Department of Neurosurgery, Huashan Hospital||Recruiting|
|Shanghai, Shanghai, China, 200040|
|Contact: Xuehai Wu, PhD +8613764880571 firstname.lastname@example.org|
|Principal Investigator:||Xuehai Wu, PhD||Huashan Hospital|