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

39049

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.

2018-09-15

2024-01-10

2024-05-30

Active (not recruiting)

Early phase I

18

Inclusion Criteria: Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage Exclusion Criteria: * Age \< 18 years * History of epileptic seizures/status epilepticus * Scalp defects * pregnancy * Severe uncompensated heart failure (NYHA IV) * Atrioventricular block (AV block) second-degree and third-degree * Known bradycardia (below 55 beats/minute) * Known long QT interval (QTc according to Bazett \> 420 ms * History of serious ventricular arrhythmias * Hypokalemia or hypomagnesemia * Impaired renal function

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme, in which "placebo" (A) and "amantadine sulphate" (B) intervention sessions alternated weekly in the same patient for a total of four weeks (A1-B1-A2-B2).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blindness about treatment'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2024-06-06