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

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.

Study Overview

• Status: Unknown
• Conditions: Consciousness Disorders
• Intervention / Treatment: Device: deep brain stimulation; Device: transcranial magnetic stimulation; Other: Routine treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xuehai Wu, PhD; Phone Number: +8613764880571; Email: wuxuehai2013@163.com
• Study Contact Backup: Name: Ying Mao, PhD; Phone Number: +862152887200; Email: maoying@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Department of Neurosurgery, Huashan Hospital
      • Contact: Xuehai Wu, PhD; Phone Number: +8613764880571; Email: wuxuehai2013@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DBS group; Besides routine treatment, Doc patients in this group will accepted deep brain stimulation treatment.	Device: deep brain stimulation; Deep brain stimulation means stimulate the brain with DBS.
Active Comparator: TMS group; Besides routine treatment, Doc patients in this group will accepted transcranial magnetic stimulation treatment.	Device: transcranial magnetic stimulation; Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
Placebo Comparator: Control group; This Doc patients will accepted routine treatment.	Other: Routine treatment; Means without above additional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xuehai Wu
• Investigators: Principal Investigator: Xuehai Wu, PhD, Huashan Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: December 20, 2015
• First Submitted That Met QC Criteria: January 28, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: deep brain stimulation; disorders of consciousness; transcranial magnetic stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Disease; Consciousness Disorders
• Other Study ID Numbers: shwuxuehai

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Ok. All participant data which can be shared will include these patient's clinical information, consciousness level and prognosis scores. Who want to share data can email to our group for data and we will glad to share.