Effects of Repetitive-Transcranial Magnetic Stimulation on Neurophysiological and Clinical Outcomes in Upper Limb Post-stroke recovery
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- To evaluate the effect of rTMS in post-stroke patients in terms of Clinical outcome measures using BI- Barthel Index, MRS-Modified Rankin Scale, NIHSS- National Institute of Health Stroke Scale, WMFT- Wolf Motor Function Test
研究概览
简要总结
In stroke majority of patients experience upper limb motor impairments, with a mere 5-20% regaining the full functionality. Upper limb dysfunction ultimately impairs a stroke patient’s quality of life and independence . This limitation can profoundly impact their daily lives, hindering activities like food, clothing, and personal cleanliness and ultimately compromising their independence. The balance between the brain hemispheres were disrupted by stroke leading to motor impairment . Researchers have investigated the use of rTMS to restore the upper limb function and also to improve the quality of life in the stroke survivors. This non-invasive technique involves stimulating either the unaffected or affected hemisphere with low-frequency or high-frequency pulses, respectively. The goal is to rebalance brain activity and promote functional recovery post-stroke .
While previous research has extensively explored the effects of rTMS on post-stroke upper limb motor recovery, the underlying neurophysiological mechanisms remain less understood. Specifically, the role of intracortical circuits, particularly GABAergic interneurons, in mediating these effects is not well-established. Additionally, the impact of rTMS on heart rate variability, and its association with frontal vagal network activity is under-investigated. Furthermore, there is a paucity of research on the effectiveness of rTMS in Indian stroke patients and the associated neurophysiological changes, considering the potential influence of ethnicity on treatment outcomes. Thus, the present study aims to investigate the impact of rTMS using neurophysiological and clinical outcomes in post-stroke upper limb recovery.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with ischemic stroke (based on TOAST criteria)
- •with upper limb motor impairment– hemiplegia/monoplegia (based on MRC scale)
- •in early sub-acute phase of stroke
- •age range 18-60 years old
- •anterior circulation stroke
- •with moderate and severe disability modified Rankin Scale (mRS) score ranges from 2 to 5
- •with moderate and severe stroke severity National Institutes of Health Stroke Scale (NIHSS) 5 to 42.
排除标准
- •Patients who i.
- •are unable to cooperate due to global aphasia ii.
- •are having cerebral venous thrombosis iii.
- •are in ICU ventilators, cardio-respiratory distress iv.
- •are having hemorrhagic stroke v.
- •are having Primary Psychiatric disorders
- •Patients have contraindications to TMS, such as those who i.
- •had a past history or family history of seizures and epilepsy ii.
- •have epileptic discharge in EEG iii.
- •have metal implants on the head and neck such as surgical clips, dental implants, cochlear implants, stents in the head and neck v.
- •having a cardiac pacemaker or cardiac stent vii.
- •are pregnant viii.
- •had a H/O cardiovascular disease such as Ischemic Heart Disease with low ejection fraction and cardiac failure ix.
- •have a history of brain tumor.
结局指标
主要结局
To evaluate the effect of rTMS in post-stroke patients in terms of Clinical outcome measures using BI- Barthel Index, MRS-Modified Rankin Scale, NIHSS- National Institute of Health Stroke Scale, WMFT- Wolf Motor Function Test
时间窗: Baseline- Preintervention Day -1 | Postintervention Day-7
次要结局
- To evaluate the effect of rTMS in post-stroke patients in terms of Neurophysiological measures using Single-pulse and paired-pulse TMS measures, Heart Rate Variability Measures (HRV) and Electroencephalographic measures (EEG)
研究者
Dr Kaviraja Udupa
National Institute of Mental Health and Neurosciences(NIMHANS))