Prismatic Adaptation for Cognitive Rehabiliation in Traumatic Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Neuropsychological primary outcome measure
研究概览
简要总结
The study aims to evaluate the effects of prismatic adaptation and then of a novel rehabilitation protocol that combines PA and Serious Games on cognitive and behavioural deficits in patients with traumatic brain injury , compared to a rehabilitation training without prismatic adaptation.
Moreover, this study aims to assess the impact of this rehabilitation protocol on functional cognitive outcomes.
Hypothesis Hypothesis 1 (H1): It is postulated that the utilization of Prismatic Adaptation Treatment (PAT) has a positive impact on the enhancement of cognitive outcome among patients suffering from TBI
Hypothesis 2 (H2): It is hypothesized that there will be discernible alterations in resting-state Electroencephalography (EEG) patterns between the initial assessment point (T0) and the subsequent measurement during the course of treatment (T1) in individuals diagnosed with TBI
Assessment times of outcome measures will be conducted before the experimental treatment (T0) and after the 10 rehabilitation sessions (T1).
Patients will be randomized into two groups:
- Experimental group: Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session.
- Control group: patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.
Both groups will receive also the standard cognitive rehabilitation for the detected deficits, using paper and pen materials.
Each rehabiliation session will last aproximately 1 hour for 5 days a week for 2 weeks.
详细描述
Background Neurological diseases, such as Traumatic Brain Injury (TBI), represent a significant public health concern, with profound consequences on cognitive functions and overall quality of life. Attention, memory, and executive functions and behaviour are the cognitive domains usually impacted by TBI. Attentional and executive deficits represent the most pronounced cognitive deficits that impact every activity of daily life. As the field of neurorehabilitation continues to evolve, exploring innovative interventions becomes imperative. This study explores the efficacy of a promising modality, such as Prism Adaptation Treatment (PAT) on the cognitive rehabilitation of individuals with neuropsychological deficits following traumatic brain injury Prismatic lenses have shown potential in addressing visual and perceptual deficits and the association with cognitive rehabilitation with Serious Games could offer a dynamic cognitive rehabilitation means. Understanding the effects of these interventions would allow an enhancement of cognitive functions, providing valuable insights for developing effective and targeted rehabilitation strategies for patients. This research aims to contribute to the growing body of knowledge in neurorehabilitation and paves the way for improved therapeutic approaches to manage cognitive deficits following TBI.
Prismatic Lenses
Prism adaptation (PA) is a form of procedural learning in which the motor system adapts to new visuospatial coordinates imposed by prismatic lenses that displace the visual field horizontally. By introducing prisms that deviate the visual fields during movements, patients show initial pointing errors in the direction of the prism deviation. PA involves the progressive adaptation of patients to this visual distortion, gradually compensating for the initial errors over pointing trials. Removing prismatic lenses ends in a deviation of spatial attention towards the contralateral side. Studies on brain lesions unfold the neural circuitry underlying PA as a parieto-cerebellar network, where the anterior intraparietal sulcus detects the visual-motor misalignment produced by prisms, and the parieto-occipital sulcus invokes changes to correct the internal movement models.
The aftereffect, which can be observed in the spatial deviation of the motor actions in the direction opposite to the visual displacement imposed by the prisms, is a reliable measure of the degree and strength of the adaptation.
Prismatic lenses are typically adopted as a rehabilitative treatment for patients with visuospatial deficits, mainly Spatial Neglect (SN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years
- •Traumatic brain injury (TBI)
- •Rancho Level of Cognitive Functioning (LCF) for TBI patients > 4
- •Admission within 90 days from the onset
排除标准
- •Unilateral Spatial Neglect
- •Severe vigilance deficits
- •Severe verbal comprehension deficits
- •Motor deficits of both hands
- •Previous neurological stroke
- •Previous neurological disease
- •Previous psychiatric disease
- •Use of alcohol or drugs
- •Severe visual deficits
- •Premorbid dementia
研究组 & 干预措施
Prismatic adaptation group
Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. This training will be administered using a class I medical device SaMD (Software as a Medical Device) associated to prisms.
干预措施: PRISMATIC ADAPTATION (Device)
Prismatic adaptation group
Patients receiving treatment with prismatic lenses and serious games lasting 10 days over a span of 2 weeks, for 40 minutes each session. This training will be administered using a class I medical device SaMD (Software as a Medical Device) associated to prisms.
干预措施: Serious games (Device)
Control group
patients receiving the same serious games for 10 days over a span of 2 weeks, withouth prismatic adaptation session.
干预措施: Serious games (Device)
结局指标
主要结局
Neuropsychological primary outcome measure
时间窗: From the enrollment to the end of treatment at 2 weeks.
\- Montreal Cognitive Assessment (MoCA) (0-30). High score means a better outcome.
次要结局
- Neuropsychological outcome measure(From the enrollment to the end of treatment at 2 weeks.)
- Neuropsychiatric outcome(From the enrollment to the end of treatment at 2 weeks.)
- Neurophysiological secondary outcome(From the enrollment to the end of treatment at 2 weeks.)