Persistent vegetative state (PVS) patients
Conditions
Interventions
Study group (Zolpidem): 10mg dose of Zolpidem. Zolpidem tablets were cracked and duly mixed with 15 ml of cherry syrup. Single dose by oral route for healthy volunteers
and by percutaneous endoscopic gastrostomies route for patients. Control group (Placebo): 10mg sucrose + 30 mg of inert solid excipient. Single dose by oral route for healthy volunteers and by percuta
Sponsors
Institute of Neurology and Neurosurgery "Prof. Rafael Estrada Gonzalez"
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion criteria for patients •Persistent vegetative state patients were diagnosed according to current diagnostic criteria from the American Academy of Neurology • Patients showed eye movements with lack of fixation, no evidence of awareness of self or environment, lack of interaction with others, and no comprehension or expression of language. •Patients with an age no less than 16 years old •One month at least of clinical evolution Inclusion criteria for control normal subjects •Normal subjects, matched in sex and age with patients •Normal subjects did not have a history of any neurological or other chronic diseases, and they were not under any medication. •No history of being under medication such asr Zolpidem or a related benzodiazepine medication •Willingness to participate in the protocol
Exclusion criteria
Exclusion criteria: Exclusion criteria for patients •Patients who evidence of awareness of self or environment, some cognitive function, and interaction with others. •Patients with less than 16 years old •Less than one month of clinical evolution •Patients with the Diabetes Mellitus, or other systemic disease affecting the autonomic system Exclusión criteria for normal control subjects •Younger than 16 years old •Diagnosis of neurological, cardiologic, or other systemic diseases, •Presence de signs electrocardiographic signs of ischemia or arrhythmia •Being under the use of zolpidem, or other benzodiazepine drugs. •No willingness of participating in the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JFK Coma Recovery Scale-Revised (CRS-R). Measuring time: before and after each administration. Autonomic variables (heart variability indices calculated for time and frequency dominium). Measuring time: during 20 minutes (basal record), and during 120 minutes after each administration. EEG (percent of activated and non-activated EEG segments). Measuring time: during 20 minutes (basal record), and during 120 minutes after each administration. | — |
Countries
Cuba
Contacts
Public ContactCalixto Machado-Curbelo
Institute of Neurology and Neurosurgery "Prof. Rafael Estrada Gonzalez"
Outcome results
None listed