Gamma Entrainment Improve the Recovery of Awareness

NCT05640544 | Unknown

• 1 other identifier: 20212209
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness

Outcome Measures

Primary Outcomes (1)

• 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.

  Synchronous recording during stimulation procedure

Secondary Outcomes (3)

• CRS-R scale

  at two weeks, 3 months, 6 months and 1 year after the onset.

• Glasgow Outcome Scale - Extended (GOS-E)

  at two weeks, 3 months, 6 months and 1 year after the onset.

• Modified Rankin Scale (mRS)

  at two weeks, 3 months, 6 months and 1 year after the onset.

Study Arms (1)

Sound and light stimulation in Gamma band

EXPERIMENTAL

Other: Sound and light stimulation in Gamma band

Interventions

Sound and light stimulation in Gamma band 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.

Sound and light stimulation in Gamma band

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Neurology, Xijing Hospital, Air Force Medical University

Xi'an, China

RECRUITING

MeSH Terms

Conditions

Consciousness Disorders

Interventions

Sound

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Xiaogang Kang, MD,PhD

CONTACT

86-029-15129935875; paraq@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 7, 2022
• Study Start: March 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2025
• Last Updated: December 7, 2022

Record last verified: 2021-12

Locations

CN (1)