NCT06443827

Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Azienda Sanitaria dell'Alto Adige · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Amantadine
• Consciousness Disorders
• Electroencephalography

Interventions

Type	Name	Description
DRUG	Amantadine Sulfate	intravenous amantadine sulphate at a single daily dose of 200 mg or physiological saline (0.9% NaCl solution)

Timeline

• Start date: 2018-09-15
• Primary completion: 2024-01-10
• Completion: 2024-09-30
• First posted: 2024-06-05
• Last updated: 2024-06-14

Locations

1 site across 1 country: Italy