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Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

Primary Purpose

Consciousness Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DC-Stimulator, NeuroConn, Germany
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Consciousness Disorder focused on measuring disorders of consciousness, electric stimulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of disorders of consciousness based on CRS-R
  • Time post-injury ranging from one to twelve months
  • No history of acquired brain injury or psychiatric or neurological diseases

Exclusion Criteria:

  • Not medically stable
  • Any contraindication to electric stimulation
  • Hearing impairment before brain injury

Sites / Locations

  • First Affiliated Hospital,Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Gamma modulation effect

Beta modulation effect

Sham modulation group

Arm Description

40Hz current is applied by a battery-driven current stimulator(NeuroConn, Germany). Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3), respectively. 40Hz acoustic stimuli and 40Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days.

28Hz current is applied by a battery-driven current stimulator. Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3). 28Hz acoustic stimuli and 28Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days.

Sham stimulation was identical to the 40Hz stimulation, except that the acoustic and electric stimulation were ramped down after 0.5 min to remain turned off for the remaining 39.5 min. Sham stimuli are applied for 40min/day, for a total of 5 days.

Outcomes

Primary Outcome Measures

Coma Recovery Scale-Revised scores
Coma Recovery Scale-Revised(CRS-R) scores are the gold standard for consciousness. CRS-R consists of 23 items, grouped into 6 sub-scales: auditory, visual, motor, oromotor, communication and arousal. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best).
Neuropsychological assessment
EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300).
Glasgow Outcome Scale-Extended
A widely used index for outcomes after brain injury

Secondary Outcome Measures

Full Information

First Posted
June 11, 2020
Last Updated
November 18, 2021
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Maastricht University, Zhejiang Mingzhou Brain Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04435301
Brief Title
Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness
Official Title
Acoustic-electric Therapy in Patients With Disorders of Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 20, 2020 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Maastricht University, Zhejiang Mingzhou Brain Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Altered gamma activity has been observed in several neurological and psychiatric disorders, including a reduction in gamma synchronization in patients with disorders of consciousness. Modulation of gamma oscillations with rhythmic stimulation has been used as a possible therapeutic tool. Hence, we try to use acoustic and electric stimulation at gamma frequency to restore brain oscillation and thereby to improve conscious awareness in patients with disorders of consciousness.
Detailed Description
We propose a matched-pair parallel study in patients with disorders of consciousness to investigate whether combined acoustic and trigeminal nerve stimulation can modulate brain oscillations, as measured by electroencephalography (EEG), and whether the brain activity changes are coupled with improvements in consciousness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorder
Keywords
disorders of consciousness, electric stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gamma modulation effect
Arm Type
Experimental
Arm Description
40Hz current is applied by a battery-driven current stimulator(NeuroConn, Germany). Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3), respectively. 40Hz acoustic stimuli and 40Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days.
Arm Title
Beta modulation effect
Arm Type
Experimental
Arm Description
28Hz current is applied by a battery-driven current stimulator. Two pairs of electrodes are attached to the middle and lower part of the face to stimulate the maxillary nerve (V2) and the mandibular nerve (V3). 28Hz acoustic stimuli and 28Hz electric stimuli are synchronously applied for 40min/day, for a total of 5 days.
Arm Title
Sham modulation group
Arm Type
Sham Comparator
Arm Description
Sham stimulation was identical to the 40Hz stimulation, except that the acoustic and electric stimulation were ramped down after 0.5 min to remain turned off for the remaining 39.5 min. Sham stimuli are applied for 40min/day, for a total of 5 days.
Intervention Type
Device
Intervention Name(s)
DC-Stimulator, NeuroConn, Germany
Intervention Description
Neurostimulation device
Primary Outcome Measure Information:
Title
Coma Recovery Scale-Revised scores
Description
Coma Recovery Scale-Revised(CRS-R) scores are the gold standard for consciousness. CRS-R consists of 23 items, grouped into 6 sub-scales: auditory, visual, motor, oromotor, communication and arousal. The lowest score on each sub-scale represents reflexive activity; the highest represents behaviors mediated by cognitive input. The total score ranges between 0 (worst) and 23 (best).
Time Frame
Day 1-5, Day 11-15
Title
Neuropsychological assessment
Description
EEG indicators could be used to assess the conscious level, including gamma oscillations and event-related potentials(P300).
Time Frame
Day 5 and Day 11
Title
Glasgow Outcome Scale-Extended
Description
A widely used index for outcomes after brain injury
Time Frame
1 year after stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of disorders of consciousness based on CRS-R Time post-injury ranging from one to twelve months No history of acquired brain injury or psychiatric or neurological diseases Exclusion Criteria: Not medically stable Any contraindication to electric stimulation Hearing impairment before brain injury
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benyan Luo
Organizational Affiliation
The First Affiliated Hospital, Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
First Affiliated Hospital,Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30448386
Citation
Fan S, Wu X, Xie M, Li X, Liu C, Su Y, Chen Y, Wu S, Ma C. Trigeminal nerve stimulation successfully awakened an unconscious patient. Brain Stimul. 2019 Mar-Apr;12(2):361-363. doi: 10.1016/j.brs.2018.11.001. Epub 2018 Nov 3. No abstract available.
Results Reference
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Oscillatory Acoustic-electric Stimulation in Patients With Disorders of Consciousness

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