Efficacy of Neuromodulation and Cognitive Rehabilitation Therapy in Enhancing Neuroplasticity in Patients with Traumatic Brain Injury.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This Randomized parallel group, placebo-controlled trial evaluates the efficacy of neuromodulation combined with cognitive rehabilitation therapy in enhancing neuroplasticity among patients with traumatic brain injury. Group A (n = 20) receives active transcranial direct current stimulation (tDCS) with cognitive rehabilitation therapy, while Group B (n = 20) receive placebo tDCS with cognitive rehabilitation therapy. Both groups undergo interventions thrice weekly over six months, total 72 sessions of 90 minutes with inclusive resting time. Four time periods will be used to evaluate all outcome measure: two baseline assessments (Pre-intervention) one month apart, post-intervention (6 month), and a three-month follow-up. Primary Outcomes are EEG (neuroplasticity), MoCA (Cognitive function), FMA (Motor recovery) and Secondary Outcomes are FIM (Functional Independence), QoL SF-36 (Quality of Life).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria Adult aged 18 to 50 years.
- •Diagnosis of Mild to moderate traumatic Brain Injury (TBI) confirmed by clinical assessment and imaging.
- •Minimum Post Injury duration of 3 months.
- •Presence of Neurocognitive deficits as per the MoCA Scale Able to Provide Informed consent.
排除标准
- •Exclusion Criteria Sever TBI Glasgow Coma Scale less than
- •Pre existing neurological of psychiatric disorders.
- •Implanted medical devices any pacemaker or cochlear implants.
- •Pregnancy or breastfeeding.
- •Patient with history of epilepsy or seizure.
- •Progressive neurodegenerative diseases, Major psychiatric disorders such as schizophrenia, bipolar disorder, major depression are excluded.
研究者
A YASHUDAS
Lovely Professional University