Effect of Virtual Cognitive Retraining Program on Neuropsychological Functioning & Hemodynamic Response in Traumatic Brain Injury: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Processing speed
研究概览
简要总结
Traumatic brain injuries (TBI) pose a significant public health challenge in India, with over 6.5 million reported cases in 2019. Men, particularly those aged 16-35, are most affected, primarily due to road traffic accidents. TBIs lead to disabilities that impact sustained attention, planning, initiation, perseverance, and task completion. They also cause difficulties in response inhibition and impair social and occupational functioning. Cognitive retraining is a proven strategy for neuropsychological rehabilitation, enhancing cognitive functions across various neurological and neuropsychiatric disorders. Traditional cognitive retraining programs typically last 5-6 weeks in hospital settings. However, there is a growing need for virtual programs to increase accessibility and reduce costs. Despite advancements, research on cognitive retraining’s impact, particularly neuroplastic changes assessed through brain imaging, remains limited. Only 11 studies from 1985 to 2016 have used neuroimaging to evaluate neuroplastic changes following cognitive retraining in TBI patients. Functional Near-Infrared Spectroscopy (fNIRS) is a promising, non-invasive brain imaging technique. Its cost-effectiveness and mobility make it ideal for assessing resting state and task-based hemodynamic responses (HbO-HbR), especially in individuals with head injuries. This research aims to evaluate the impact of a Virtual Cognitive Retraining Program, delivered via Google Meet, on the neuropsychological functioning of mild to moderate TBI patients with a Glasgow Coma Scale (GCS) score between 9 and 15. The study will also investigate hemodynamic responses using fNIRS. This randomized controlled trial (RCT) includes one treatment arm and one active control arm, each with 20 mild/moderate TBI patients. An equivalent number of age-matched healthy participants will be recruited for comparative analysis, focusing on neuropsychological functioning and hemodynamic responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •a.Clinically stable patients with a diagnosis of Traumatic Brain Injury.
- •b.Normal/corrected vision and hearing.
- •c.Handedness Right.
- •d.Minimum time elapsed since head injury: Three months.
- •e.Total score of 9-15 on the Glasgow Coma Scale at the time of injury.
- •f.Presence of neuropsychological deficit.
- •g.Access to a personal computer or smartphone.
- •h.Familiarity with video calling and mobile phone applications.
- •i.Ability to read and write, Hindi, English or Kannada.
排除标准
- •a.Severe sensorimotor, personality changes and language deficits making them not amenable to testing.
- •b.Decompressive Craniotomy without bone replacement.
- •c.History of substance dependence (except tobacco).
- •d.History of mental retardation.
- •e.History of psychiatric, neurological, or neurosurgical conditions.
- •f.History of a chronic debilitating medical condition.
- •g.Undergoing psychological intervention, in the past 6 months.
- •h.No access to a personal computer or mobile phone.
结局指标
主要结局
Processing speed
时间窗: Baseline, 1 week Post intervention
Working memory
时间窗: Baseline, 1 week Post intervention
Oxy-Hemoglobin (HbO)
时间窗: Baseline, 1 week Post intervention
Deoxy-hemoglobin (HbR)
时间窗: Baseline, 1 week Post intervention
次要结局
- WHO Quality of life (brief)(Rivermead Head Injury Follow Up Questionnaire)
研究者
Rahul Joshi
National Institute of Mental Health and Neurosciences