Chronic Vegetative State
Conditions
Keywords
chronic vegetative state, RPh201, functional MRI
Brief summary
The investigators are studying the impact of RPh201 on chronic vegetative patients. RPh201 has been reported to induce neuronal regeneration in animal models. Evaluation will be done by combining clinical /behavioral assessment with fMRI studies.
Interventions
DIETARY_SUPPLEMENTRPh201
Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
DIETARY_SUPPLEMENTsaline
Patients will receive 400 microliter s.c., of saline twice a week for 3 months
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Chronic vegetative patients
Exclusion criteria
* Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the awareness status of the patients. | 3-6 months | Clinical and laboratory assessment will be done every two weeks along the treatment period fMRI assessment will be performed 3 times: before the treatment, immediate afterwards and one month following treatment cessation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the awareness status of the patients. | 1 month following the end of the trial | clinical and fMRI assessment will be performed 1 month following treatment cessation |
Outcome results
None listed