EFFECT OF ANODAL TRANSCRANIAL DIRECT CURRENT STIMULATION ON NAMING IN APHASIC PATIENTS WITH ACUTE ISCHEMIC STROKE
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days
研究概览
简要总结
The use of transcranial direct current stimulation (tDCS) for the management of deficits developed in stroke is a relatively new type of management option. Many of the studies performed using tDCS have focused on improvements noted in hemiplegia as compared to aphasia, which is an equally disabling outcome of strokes. The results of these studies have not been conclusive and concordant with each other.
In aphasia management, the majority of the studies have focused on chronic strokes. Since the use of tDCS is relatively new, the studies have not focused on a particular type of deficit or stroke. Very few studies have focused on the impact of solely using tDCS. Very few studies have focused on acute to subacute strokes. The results of the studies have, nevertheless, been encouraging.
Improvements in aspects of language tested after a single session of tDCS are short-lived. There is an unmet need to probe the utility of repetitive tDCS on aspects of language function in patients who are aphasic due to acute stroke. There is also a paucity of data in the Indian scenario regarding the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aphasic patients with left middle cerebral artery territory Acute Ischemic Stroke
- •Patients between 18-65 years of age.
- •Within 5 days of onset of stroke.
排除标准
- •Patients with malignant Middle Cerebral Artery territory infarcts and previous clinical history of cerebral hemisphere stroke.
- •Patients with history of previous brain surgery or skull defect due to surgery e.g. craniectomy.
- •Patients with epilepsy.
- •Patients with history of significant head trauma in the last 1 month.
- •Patients with documented history of major depression prior to stroke.
- •Patients with alcohol/drug abuse in the past 6 months.
- •Patients with prior significant cognitive impairment.
- •Pacemaker in situ, cochlear implant in situ.
- •Pregnancy.
结局指标
主要结局
Primary Outcome: Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 5 days
时间窗: at 5 days after tDCS
Accuracy is defined as the number of words spoken without the help of a semantic or phonemic cue on the ICMR Picture Naming Test
Co-Primary outcome: Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 5 days
时间窗: at 5 days after tDCS
Reaction times were documented in milliseconds.
次要结局
- Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 5 days(at 5 days after tDCS)
- Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 5 days(at 5 days after tDCS)
- Difference of change in Accuracy between Anodal tDCS group and Sham tDCS group at 4 weeks(at 4 weeks after tDCS)
- Difference of change in Reaction Time between Anodal tDCS group and Sham tDCS group at 4 weeks(at 4 weeks after tDCS)
- Difference of change in Correct Response between Anodal tDCS group and Sham tDCS group at 4 weeks(at 4 weeks after tDCS)
- Difference of change in PNT Score between Anodal tDCS group and Sham tDCS group at 4 weeks(at 4 weeks after tDCS)
研究者
Dr Ashish Kumar Duggal
Professor, Department of Neurology, ABVIMS and Dr RML Hospital, New Delhi
Dr. Ram Manohar Lohia Hospital