NCT02667899

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

5 years

First QC Date

December 20, 2015

Last Update Submit

June 25, 2019

Conditions

Consciousness Disorders

Keywords

disorders of consciousnessdeep brain stimulationtranscranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The conscious index based on fMRI

    3 months

  • The conscious index based on EEG

    3 months

Study Arms (3)

DBS group

ACTIVE COMPARATOR

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

Device: deep brain stimulation

TMS group

ACTIVE COMPARATOR

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

Device: transcranial magnetic stimulation

Control group

PLACEBO COMPARATOR

This Doc patients will accepted routine treatment.

Other: Routine treatment

Interventions

deep brain stimulationDEVICE

Deep brain stimulation means stimulate the brain with DBS.

DBS group
transcranial magnetic stimulationDEVICE

Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.

TMS group
Routine treatmentOTHER

Means without above additional treatment.

Control group

Eligibility Criteria

Age14 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ages 14 to 65 years old;
  • DOC patients, including vegetative state and minimally consciousness state.
  • 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;
  • Written informed consent from patient families

You may not qualify if:

  • History with nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
  • Patients with V-P shunt or ommaya implantation, which may effects magnetic resonance scan signal analysis;
  • Body temperature is abnormal, vital signs is not stable, still need ventilator to support breathing; Plentiful sputum needed suction during MRI scans.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Deep Brain StimulationTranscranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, OperativeMagnetic Field Therapy

Study Officials

  • Xuehai Wu, PhD

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehai Wu, PhD

CONTACT

+8613764880571wuxuehai2013@163.com

Ying Mao, PhD

CONTACT

+862152887200maoying@fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 20, 2015

First Posted

January 29, 2016

Study Start

November 1, 2015

Primary Completion

November 1, 2020

Study Completion

November 1, 2022

Last Updated

June 27, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

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.

Locations

CN(1)