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Gamma Entrainment Improve the Recovery of Awareness

Primary Purpose

Disorder of Consciousness

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sound and light stimulation in Gamma band
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disorder of Consciousness

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 16-80 years; Clinical diagnosis of VS/UWS or MCS according to the CRS-R score within one week after admission; Time post-onset > 28 days. Exclusion Criteria: Previous history of acquired brain injury or psychiatric or neurodegenerative diseases; Clinical diagnosis of epilepsy; Visual or auditory pathway damage; Life threatening comorbidity, coexisting neoplasms, severe organ dysfunction, or unstable clinical condition (e.g., hemodynamic instability or severe respiratory failure); Incomplete clinical data.

Sites / Locations

  • Department of Neurology, Xijing Hospital, Air Force Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sound and light stimulation in Gamma band

Arm Description

Outcomes

Primary Outcome Measures

The changes of EEG during stimulation procedure
The changes of Gamma oscillation, the temporal and spatial distribution of Gamma band power and the changes of Gamma band brain network are analyzed before and after stimulation.

Secondary Outcome Measures

CRS-R scale
The CRS-R is used to assess patients with disorders of consciousness. 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).
Glasgow Outcome Scale - Extended (GOS-E)
The GOS-E is one of the most widely used outcome instruments to assess global disability and recovery after brain injury. The Scale extends the original 5 GOS categories to 8. The total score ranges between 1 (worst) and 8 (best).
Modified Rankin Scale (mRS)
The mRS assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. It is an ordered scale coded from 0 (no symptoms at all) to 6 (death).

Full Information

First Posted
October 31, 2022
Last Updated
December 6, 2022
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05640544
Brief Title
Gamma Entrainment Improve the Recovery of Awareness
Official Title
Gamma Entrainment Improve the Recovery of Awareness in Disorders of Consciousness
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to elucidate the occurrence of Gamma entrainment and optimize the acousto-optic stimulation parameters to induce it in patients with disorders of consciousness (DOC), to explore the prognostic value of gamma entrainment in patients with DOC, and to clarify the effect of gamma entrainment on the recovery of awareness in DOC patients. This study is divided into three parts. The first and third parts are prospective cohort studies, the second part is a randomized cross control study. We recruit DOC patients, including vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS). The patients receive sound and light stimulation in the Gamma band, and the changes of EEG are observed simultaneously to explore the occurrence of Gamma entrainment. Meanwhile, the changes of clinical behavior of patients before and after stimulation are evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Consciousness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sound and light stimulation in Gamma band
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Sound and light stimulation in Gamma band
Intervention Description
We expect to screen out the efficacy of Gamma band in the prognosis and treatment of disorders of consciousness by various frequencies of stimulation. Optical stimulation: A computer program is used to control the flashing frequency of LED lights for stimulation. The serial port can convert the parallel data characters of the computer CPU into a continuous serial data stream. According to the frequency designed by experiment (10Hz, 20hz, 40hz, 80hz), we modulate the flicker frequency of LED lamp. LED lamp uses T8 lamp, diameter 25.4 mm, length 620 mm, and power 20W. Acoustic stimulation: We use Adobe Audition CC 2022 to modulate the tones. The tones modulated to 10Hz, 20Hz, 40Hz and 80Hz are play by noise-canceling headphones to the patients.
Primary Outcome Measure Information:
Title
The changes of EEG during stimulation procedure
Description
The changes of Gamma oscillation, the temporal and spatial distribution of Gamma band power and the changes of Gamma band brain network are analyzed before and after stimulation.
Time Frame
Synchronous recording during stimulation procedure
Secondary Outcome Measure Information:
Title
CRS-R scale
Description
The CRS-R is used to assess patients with disorders of consciousness. 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
at two weeks, 3 months, 6 months and 1 year after the onset.
Title
Glasgow Outcome Scale - Extended (GOS-E)
Description
The GOS-E is one of the most widely used outcome instruments to assess global disability and recovery after brain injury. The Scale extends the original 5 GOS categories to 8. The total score ranges between 1 (worst) and 8 (best).
Time Frame
at two weeks, 3 months, 6 months and 1 year after the onset.
Title
Modified Rankin Scale (mRS)
Description
The mRS assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. It is an ordered scale coded from 0 (no symptoms at all) to 6 (death).
Time Frame
at two weeks, 3 months, 6 months and 1 year after the onset.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 16-80 years; Clinical diagnosis of VS/UWS or MCS according to the CRS-R score within one week after admission; Time post-onset > 28 days. Exclusion Criteria: Previous history of acquired brain injury or psychiatric or neurodegenerative diseases; Clinical diagnosis of epilepsy; Visual or auditory pathway damage; Life threatening comorbidity, coexisting neoplasms, severe organ dysfunction, or unstable clinical condition (e.g., hemodynamic instability or severe respiratory failure); Incomplete clinical data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaogang Kang, MD,PhD
Phone
86-029-15129935875
Email
paraq@163.com
Facility Information:
Facility Name
Department of Neurology, Xijing Hospital, Air Force Medical University
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaogang Kang, MD, PhD

12. IPD Sharing Statement

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Gamma Entrainment Improve the Recovery of Awareness

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