Gamma entrainment to enhance awareness recovery in patients with consciousness disorders
Gamma Entrainment Improve the Recovery of Awareness in Disorders of Consciousness
This study is testing if sound and light stimulation can help improve awareness in patients with severe consciousness disorders like vegetative state or minimally conscious state.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 16 Years to 80 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an) |
| Trial ID | NCT05640544 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the effects of gamma entrainment through sound and light stimulation on patients with disorders of consciousness (DOC), specifically those in vegetative state/unresponsive wakefulness syndrome (VS/UWS) or minimally conscious state (MCS). It consists of three parts: two prospective cohort studies and one randomized controlled study, where patients will receive stimulation while their EEG changes and clinical behaviors are monitored. The goal is to optimize stimulation parameters and assess the prognostic value of gamma entrainment in improving awareness recovery.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 16-80 years diagnosed with VS/UWS or MCS within one week of admission, and who have been in this state for more than 28 days.
Not a fit: Patients with a history of acquired brain injury, psychiatric or neurodegenerative diseases, or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance recovery of awareness in patients with disorders of consciousness.
How similar studies have performed: While the concept of gamma entrainment is being explored, this specific approach in DOC patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an
- Department of Neurology, Xijing Hospital, Air Force Medical University — Xi'an, China (Recruiting)
Study contacts
- Study coordinator: Xiaogang Kang, MD,PhD
- Email: paraq@163.com
- Phone: 86-029-15129935875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.