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due to lack of supply of medication and technical problems with the MRI
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RPh201 group | Active Comparator | 7 patients will receive the treatment |
|
| non RPh201 group | Placebo Comparator | 3 patients will receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RPh201 | Drug | 400 microliter s.c. twice a week for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| consciousness level measured clinically | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional magnetic resonance imaging of cortical activity | 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 | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netta Levin | Jerusalem | Israel |
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| ID | Term |
|---|---|
| D018458 | Persistent Vegetative State |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline |
| Drug |
400 microliter Saline solution s.c. twice a week for 3 months |
|
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |