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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02667899

Enrollment

Registered

2016-01-29

Start date

2015-11-30

Completion date

2022-11-30

Last updated

2019-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consciousness Disorders

Keywords

disorders of consciousness, deep brain stimulation, transcranial magnetic stimulation

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.

Interventions

DEVICEdeep brain stimulation

Deep brain stimulation means stimulate the brain with DBS.

DEVICEtranscranial magnetic stimulation

Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.

OTHERRoutine treatment

Means without above additional treatment.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)	3 months	revised-coma recovery scale(CRS-R)

Secondary

Measure	Time frame	Description
The conscious index based on fMRI	3 months	Using fMRI to evaluate consciousness in DoC patients
The conscious index based on EEG	3 months	Using EEG to evaluate consciousness in DoC patients

Countries

China

Contacts

Primary ContactXuehai Wu, PhD

wuxuehai2013@163.com+8613764880571

Backup ContactYing Mao, PhD

maoying@fudan.edu.cn+862152887200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026