Chronic Vegetative State
Conditions
Keywords
chronic vegetative state, functional MRI
Brief summary
The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.
Interventions
DRUGRPh201
400 microliter s.c. twice a week for 3 months
DRUGSaline
400 microliter Saline solution s.c. twice a week for 3 months
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* chronic vegetative state patients
Exclusion criteria
* allergic reaction to treatment * patients that can not undergo MRI * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| consciousness level measured clinically | 6 months | Each patient will undergo a behavioral assessment (using the Coma Recovery Scale Revised) before treatment and every 2 weeks during the treatment period as well as 3 months following the end of the treatment. Complete blood counts, electrolytes, liver function tests, renal function tests and ECG will be performed every two weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional magnetic resonance imaging of cortical activity | 6 months | 3 scans will be performed: before treatment, after three months of treatment and 3 months after cessation of treatment. Scanning sessions will include a hierarchical auditory paradigm, an imagery task and resting state fMRI |
Countries
Israel
Outcome results
None listed