NCT05640544

Gamma Entrainment Improve the Recovery of Awareness

Gamma Entrainment Improve the Recovery of Awareness in Disorders of Consciousness

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 16 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2023-06-30
• Completion: 2025-12-31
• First posted: 2022-12-07
• Last updated: 2022-12-07

Locations

1 site across 1 country: China