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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
Sponsor:
Information provided by (Responsible Party):
Xuehai Wu, Huashan Hospital

Brief 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. 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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. The conscious index based on fMRI [ Time Frame: 3 months ]
    Using fMRI to evaluate consciousness in DoC patients

  2. The conscious index based on EEG [ Time Frame: 3 months ]
    Using EEG to evaluate consciousness in DoC patients



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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients ages 14 to 65 years old;
  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:

  1. History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
  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.

Information from the National Library of Medicine

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


Contacts
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Contact: Xuehai Wu, PhD +8613764880571 wuxuehai2013@163.com
Contact: Ying Mao, PhD +862152887200 maoying@fudan.edu.cn

Locations
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China, Shanghai
Department of Neurosurgery, Huashan Hospital Recruiting
Shanghai, Shanghai, China, 200040
Contact: Xuehai Wu, PhD    +8613764880571    wuxuehai2013@163.com   
Sponsors and Collaborators
Xuehai Wu
Investigators
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Principal Investigator: Xuehai Wu, PhD Huashan Hospital

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Responsible Party: Xuehai Wu, Associate Professor, Huashan Hospital
ClinicalTrials.gov Identifier: NCT02667899     History of Changes
Other Study ID Numbers: shwuxuehai
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by Xuehai Wu, Huashan Hospital:
disorders of consciousness
deep brain stimulation
transcranial magnetic stimulation
Additional relevant MeSH terms:
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Consciousness Disorders
Disease
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders