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Status:

UNKNOWN

D-aspartate and Therapeutic Exercise

Lead Sponsor:

Neuromed IRCCS

Conditions:

Brain Injuries

Eligibility:

All Genders

18-80 years

Phase:

EARLY_PHASE1

Brief Summary

An important mechanism responsible for clinical recovery after neurological damage of different types is synaptic plasticity. Nervous tissue can enhance or de-energize inter-neuronal transmission at s...

Detailed Description

An important mechanism responsible for clinical recovery after neurological damage of different types is synaptic plasticity. Nervous tissue can enhance or de-energize inter-neuronal transmission at s...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 22 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2022

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT03228524

    Start Date

    November 22 2017

    End Date

    December 1 2022

    Last Update

    March 15 2019

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    IRCCS Neuromed

    Pozzilli, Isernia, Italy, 86077