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Gamma Entrainment Improve the Recovery of Awareness

A

Air Force Military Medical University of People's Liberation Army

Status

Enrolling

Conditions

Disorder of Consciousness

Treatments

Other: Sound and light stimulation in Gamma band

Study type

Interventional

Funder types

Other

Identifiers

NCT05640544
20212209

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

16 to 80 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Sound and light stimulation in Gamma band
Experimental group
Treatment:
Other: Sound and light stimulation in Gamma band

Trial contacts and locations

1

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Central trial contact

Xiaogang Kang, MD,PhD

Data sourced from clinicaltrials.gov

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