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

Xuehai Wu

Status: Unknown

Conditions: Consciousness Disorders

Treatments: Other: Routine treatment; Device: deep brain stimulation; Device: transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02667899

shwuxuehai

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

75 participants in 3 patient groups, including a placebo group

DBS group

Active Comparator group

Description:

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

Treatment:

Device: deep brain stimulation

TMS group

Active Comparator group

Description:

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

Treatment:

Device: transcranial magnetic stimulation

Control group

Placebo Comparator group

Description:

This Doc patients will accepted routine treatment.

Treatment:

Other: Routine treatment