The Impact of RPh201 on CVS Patients: Clinical and fMRI Measurements

Hadassah Medical Organization

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Conditions

Chronic Vegetative State

Interventions

RPh201DIETARY_SUPPLEMENT

Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months

salineDIETARY_SUPPLEMENT

Patients will receive 400 microliter s.c., of saline twice a week for 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic vegetative patients Exclusion Criteria: * Inability to go through an MRI scans (i.e. metal implants, neurotransmitters)and pregnancy

Outcomes

Primary Outcomes

change in the awareness status of the patients.

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.

Time frame: 3-6 months

Secondary Outcomes

change in the awareness status of the patients.

clinical and fMRI assessment will be performed 1 month following treatment cessation

Time frame: 1 month following the end of the trial

Data from ClinicalTrials.gov

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