NCT04010838

Brief Summary

Disorders of consciousness(DOC) is the most serious complications and has been widely paid attention to by the government. DOC patients cause large social and economic burden to our society for there has no effective cure so far. Spinal cord stimulation(SCS) for wake-promoting therapy has aroused scholars' attention and become a hot area recently. There was much debate about the effectiveness of SCS therapy, but because of the limitation of our understanding of consciousness and the uncertainty of parameters of the stimulation, So, to figure out the indications and effectiveness of neuromodulation therapy should be the first step, and finding individual treatment and parameter may have important implications for DOC patients.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

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

First Submitted

Initial submission to the registry

May 18, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

May 18, 2019

Last Update Submit

July 4, 2019

Conditions

Disorder of ConsciousnessMinimally Conscious StateVegetative State

Keywords

disorders of consciousnessspinal cord stimulationDoCSCS

Outcome Measures

Primary Outcomes (4)

  • the JFK Coma Recovery Scale-Revised (CRS-R) scale

    The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.

    at baseline (T0), which means 1 month before stimulation.

  • the JFK Coma Recovery Scale-Revised (CRS-R) scale

    The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.

    2 weeks after the end of the treatment (T1)

  • the JFK Coma Recovery Scale-Revised (CRS-R) scale

    The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.

    3 months after the end of the treatment (T2)

  • the JFK Coma Recovery Scale-Revised (CRS-R) scale

    The CRS-R is a tool used to characterise the level of consciousness.The CRS-R is a tool used to characterize the level of consciousness and to monitor neurobehavioural recovery in DOC. The scale consists of 23 hierarchically arranged items that comprise six subscales addressing the auditory, visual, motor, oromotor/verbal, communication and arousal processes. The lowest item on each subscale represents reflexive activity whereas the highest item represents cognitively mediated behaviors.

    6 months after the end of the treatment(T3)

Secondary Outcomes (4)

  • EEG recording in resting state with Phase Coherence analysis(PC index)

    at baseline (T0), which means 1 month before stimulation.

  • EEG recording in resting state with Phase Coherence analysis(PC index)

    2 weeks after the end of the treatment (T1)

  • EEG recording in resting state with Phase Coherence analysis(PC index)

    3 months after the end of the treatment (T2)

  • EEG recording in resting state with Phase Coherence analysis(PC index)

    6 months after the end of the treatment (T3)

Study Arms (2)

Conventional treatment

NO INTERVENTION

Spinal cord stimulation and conventional treatment

EXPERIMENTAL
Procedure: spinal cord stimulation

Interventions

spinal cord stimulationPROCEDURE

The spinal cord stimulation(SCS) is a type of implantable neuromodulation device (spinal cord stimulator) that is used to send electrical signals to select areas of the spinal cord (C2-C4 in this study) for the treatment of disorders of consciousness.

Spinal cord stimulation and conventional treatment

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 an 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 of nervous or spirit disorders, or some other serious diseases such as cardiac or pulmonary problems;
  • With contraindications of spinal cord operations.
  • Body temperature is abnormal, vital signs are not stable, still need a 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, 200000, China

RECRUITING

MeSH Terms

Conditions

Consciousness DisordersPersistent Vegetative State

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesUnconsciousness

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Central Study Contacts

Xuehai Wu, Ph.D.

CONTACT

+8613764880571wuxuehai2013@163.com

Ying Mao, Ph.D.

CONTACT

+862152887200maoying@fudan.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
People who involved with data analysis and outcomes assessment would be blind to the randomization procedure.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Random controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Huashan Hospital

Study Record Dates

First Submitted

May 18, 2019

First Posted

July 8, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2021

Study Completion

June 30, 2023

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

CN(1)