Clinical trial NCT02667899: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Consciousness Disorders
Keywords: disorders of consciousness
deep brain stimulation
transcranial magnetic stimulation
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 75
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The consciousness variation of DBS and TMS for DOC Patients in a large scale randomised trial (revised-coma recovery scale)
timeFrame: 3 months
Secondary outcomes:
measure: The conscious index based on fMRI
timeFrame: 3 months
measure: The conscious index based on EEG
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Xuehai Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: