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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

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:

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.

Sites / Locations

Department of Neurosurgery, Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

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

NCT ID

NCT02667899

First Posted

December 20, 2015

Last Updated

June 25, 2019

Sponsor

Xuehai Wu

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

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

wuxuehai2013@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ying Mao, PhD

Phone

+862152887200

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

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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