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

Consciousness Disorders Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02667899
• Other study ID #: shwuxuehai
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: November 2022

Study information

• Verified date: June 2019
• Source: Huashan Hospital
• Contact: Xuehai Wu, PhD
• Phone: +8613764880571
• Email: wuxuehai2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: November 2022
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Consciousness Disorders
• Disease

Intervention

Device:
• deep brain stimulation
Deep brain stimulation means stimulate the brain with DBS.
• transcranial magnetic stimulation
Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.

Other:
• Routine treatment
Means without above additional treatment.

Locations

Country	Name	City	State
China	Department of Neurosurgery, Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xuehai Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months
Secondary	The conscious index based on fMRI	Using fMRI to evaluate consciousness in DoC patients	3 months
Secondary	The conscious index based on EEG	Using EEG to evaluate consciousness in DoC patients	3 months