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Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness — DOC-AMSUL  

Electroencephalography Clinical Trial

Official title:
Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness

Clinical Trial Summary

Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious state) by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography (EEG) recordings.

Clinical Trial Description

Research hypothesis Intravenous amantadine sulphate treatment (200 mg) over five days improves consciousness, defined as an increase in CRS-r score of at least 3 points, and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06443827
Study type Interventional
Source Azienda Sanitaria dell'Alto Adige
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 15, 2018
Completion date September 30, 2024
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