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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2022-11-30

Brief Summary

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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

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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.

Conditions

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Consciousness Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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DBS group

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

Group Type ACTIVE_COMPARATOR

deep brain stimulation

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

transcranial magnetic stimulation

Intervention Type DEVICE

Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.

Control group

This Doc patients will accepted routine treatment.

Group Type PLACEBO_COMPARATOR

Routine treatment

Intervention Type OTHER

Means without above additional treatment.

Interventions

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deep brain stimulation

Deep brain stimulation means stimulate the brain with DBS.

Intervention Type DEVICE

transcranial magnetic stimulation

Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.

Intervention Type DEVICE

Routine treatment

Means without above additional treatment.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuehai Wu

OTHER

Sponsor Role lead

Responsible Party

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Xuehai Wu

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuehai Wu, PhD

Role: CONTACT

+8613764880571

Ying Mao, PhD

Role: CONTACT

+862152887200

Facility Contacts

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Xuehai Wu, PhD

Role: primary

+8613764880571

Other Identifiers

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shwuxuehai

Identifier Type: -

Identifier Source: org_study_id

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