Gamma Entrainment Improve the Recovery of Awareness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Disorder of Consciousness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sound and light stimulation in Gamma band

Group Type EXPERIMENTAL

Sound and light stimulation in Gamma band

Intervention Type OTHER

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.

Interventions

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Sound and light stimulation in Gamma band

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes