Effects of Intravenous Amantadine Sulphate on Brain Dynamics and Neurobehavioral Status in Patients With Disorders of Consciousness
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Coma Recovery Scale-Revised (CRS-R)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blindness about treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
amantadine sulphate and placebo with schema A-B-A-B
To obtain solid evidence of amantadine sulphate effects and their temporal dynamics, we conducted a 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).
干预措施: Amantadine Sulfate (Drug)
结局指标
主要结局
Coma Recovery Scale-Revised (CRS-R)
时间窗: days 14 and 28
Increase in the Coma Recovery Scale-Revised (CRS-R) score of at least 1 point. The CRS-R consists of 23 items divided into six subscales designed to assess: Auditory (AU), Visual (V), Motor (M), Oromotor/Verbal (O), Communication (C), and Arousal functions (AR). The total score ranges between 0 (worst) and 23 (best). The subscales are composed of hierarchically ordered items; the lowest items (0) represent reflexive activity, while the highest items (4,5,6,3,2,3 points for AU, V, M, O, C respectively) represent cognitively mediated behaviours. We adopted a cut-off score of 8 for distinguish UWS/VS (\<8) from MCS (≥8) in patients induced by amantadine sulphate vs. placebo
EEG band power alpha, beta, theta, delta
时间窗: days 14 and 28
Change in each canonical band power of EEG induced by amantadine sulphate
次要结局
- "periodic" and "aperiodic" exponents of the average power spectral density(days 14 and 28)
研究者
Viviana Versace
MD
Azienda Sanitaria dell'Alto Adige