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

Primary Purpose

Consciousness Disorders

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
deep brain stimulation
transcranial magnetic stimulation
Routine treatment
Sponsored by
Xuehai Wu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Consciousness Disorders focused on measuring disorders of consciousness, deep brain stimulation, transcranial magnetic stimulation

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurosurgery, Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

DBS group

TMS group

Control group

Arm Description

Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment.

Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment.

This Doc patients will accepted routine treatment.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

The conscious index based on fMRI
Using fMRI to evaluate consciousness in DoC patients
The conscious index based on EEG
Using EEG to evaluate consciousness in DoC patients

Full Information

First Posted
December 20, 2015
Last Updated
June 25, 2019
Sponsor
Xuehai Wu
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1. Study Identification

Unique Protocol Identification Number
NCT02667899
Brief Title
The Consciousness Variation of Deep Brain and Transcranial Magnetic Stimulation for Disorders of Consciousness Patients
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 Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xuehai Wu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorders
Keywords
disorders of consciousness, deep brain stimulation, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBS group
Arm Type
Active Comparator
Arm Description
Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment.
Arm Title
TMS group
Arm Type
Active Comparator
Arm Description
Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This Doc patients will accepted routine treatment.
Intervention Type
Device
Intervention Name(s)
deep brain stimulation
Intervention Description
Deep brain stimulation means stimulate the brain with DBS.
Intervention Type
Device
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
Intervention Type
Other
Intervention Name(s)
Routine treatment
Intervention Description
Means without above additional treatment.
Primary Outcome Measure Information:
Title
The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)
Description
revised-coma recovery scale(CRS-R)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The conscious index based on fMRI
Description
Using fMRI to evaluate consciousness in DoC patients
Time Frame
3 months
Title
The conscious index based on EEG
Description
Using EEG to evaluate consciousness in DoC patients
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xuehai Wu, PhD
Phone
+8613764880571
Email
wuxuehai2013@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Mao, PhD
Phone
+862152887200
Email
maoying@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuehai Wu, PhD
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery, Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xuehai Wu, PhD
Phone
+8613764880571
Email
wuxuehai2013@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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