D-aspartate and Therapeutic Exercise (DAsp&TerapEx)
Brain Injuries
About this trial
This is an interventional treatment trial for Brain Injuries
Eligibility Criteria
This study aims to provide preliminary data on interaction between D-aspartate and therapeutic exercise in inducing LTP cortical phenomena. The sample estimate was made by analogy after a literature analysis. In view of the risk of abandonment quite high, our intention is to recruit at least 100 subjects in a population of patients with cerebral injury of various origin (such as Multiple Sclerosis, Parkinson Disease, Dementia, Skull Trauma, Stroke, Epilepsy or Other Syndromes Neurological character), related to the neurology department of IRRCS Neuromed by Pozzilli.
Inclusion criteria:
- Males or females aged between 18 and 80;
- Presence of brain damage resulting from: Multiple Sclerosis, Parkinson's Disease, Dementia, Cranial Trauma, Neurosurgery, Stroke, Epilepsy, or Other Neurological Syndromes;
- Patient's ability to adhere to the rehabilitation treatment provided for his / her clinical condition by competent personnel;
- Female subjects can not be pregnant, can not breastfeed, have been born at least three months before the beginning of the study, undertake not to schedule a pregnancy for the duration of the study;
- Patients should be able to follow protocol guidelines throughout the study;
- Patients should be able to understand the aims and risks of the study;
- Signature of informed consent, approved by our Ethics Committee.
Exclusion criteria:
- Tumors or systemic infections;
- Patients with impaired hepatic function (ALT> 3 x ULN, Alcaline Phosphatase> 2 x ULN, bilirubin tot> 2 x ULN if associated with any increase in ALT or alkaline phosphatase); Severe or moderate renal failure;
- Other contraindications or hypersensitivity to D-aspartate or its excipients;
- Patients with other pathologies which, according to the scientific officer's opinion, prevent recruitment;
- Patients unable to even partially understand and want.
Sites / Locations
- IRCCS NeuromedRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
D-aspartato+ET
Placebo+ET
Patients will be administered oral D-aspartate (2660 mg once daily) for 6 weks. Moreover, patients will receive therapeutic exercise.
Patients will be administered oral placebo for 6 weks. Moreover, patients will receive therapeutic exercise.