the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness
Launched by KY20242235JIANGWEN · Apr 3, 2025
Trial Information
Current as of July 05, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well certain brain and muscle responses can predict recovery in patients with disorders of consciousness caused by severe brain injuries. The researchers want to understand how responses to heat and itch stimulation relate to the patients' recovery outcomes six months later. Patients will be assessed using a scale that measures their level of functioning and recovery.
To participate in this study, individuals must be at least 18 years old and have experienced brain damage for 28 to 90 days. They must also meet specific criteria indicating they are in either a vegetative state (where they are awake but not aware) or a minimally conscious state (where they show some signs of awareness). It's important to note that certain conditions, such as prior neurological disorders or recent sedation, would exclude someone from participating. This study is not yet recruiting participants, but it aims to provide valuable insights into how we can better understand and predict recovery in patients with severe brain injuries.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age ≥18 years.
- • 2. Brain damage lasts 28 to 90 days.
- • 3. It meets the diagnostic criteria of unresponsive arousal syndrome/vegetative state (UWS/VS) or microconscious state (MCS).
- • Diagnostic criteria for UWS/VS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved.
- • MCS diagnostic criteria: simple instructions can be executed; Yes/no (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS.
- • 4. All subjects' legal guardians sign informed consent forms.
- Exclusion Criteria:
- • 1. Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;
- • 2. The impact of injury on palms and soles of feet;
- • 3. History of developmental, psychiatric, or neurological disorders prior to brain injury.
- • 4. Deep sedation within 72 hours, including the use of general anesthesia.
- • 5. Increased intracranial pressure, liver/kidney failure, and hemodynamic instability within 72 hours.
- • 6. Severe co-existing systemic diseases with limited life expectancy.
About Ky20242235jiangwen
Ky20242235jiangwen is a clinical trial sponsor dedicated to advancing medical research and innovation in therapeutic solutions. With a focus on rigorous scientific methodologies and adherence to ethical standards, the organization is committed to conducting high-quality clinical trials that address unmet medical needs. By fostering collaboration with healthcare professionals and leveraging cutting-edge technologies, ky20242235jiangwen aims to bring safe and effective treatments to market, ultimately improving patient outcomes and enhancing the quality of care in diverse therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported