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Recruiting NCT05640544

Gamma Entrainment Improve the Recovery of Awareness

Conditions: Disorder of Consciousness

Sex: All
Ages: 16 Years – 80 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 80
Sponsor: Xijing Hospital

Location: China

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.

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05640544). StuddyBuddy aggregates publicly available trial information.