tDCS Associated to Blindsight Rehabilitation for the Treatment of Homonymous Hemianopsia
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Humphrey visual field 30.2 SITA standard test
研究概览
简要总结
Homonymous hemianopia is one of the most common symptoms following a neurologic damage and has many negative effects on functional abilities and daily activities.
There are two main kind of restorative rehabilitation of hemianopia: "border training", which involves exercising vision at the edge of the damaged visual field, and "blindsight training", which is based on exercising the unconscious perceptual functions in the mild of the blind hemifield.
In literature only border training effects were shown to be facilitated by transcranial direct current stimulation (tDCS).
The investigators treat two patients with blindsight rehabilitation associated to tDCS over parieto-occipital cortex. The two patients undergo a cycle of blindsight treatment associated to tDCS and a cycle of blindsight training alone in inverted order.
Aim of the study is to investigate if the anodic stimulation of perilesional areas enhance the improvement induced by blindsight rehabilitation treatment.
详细描述
The study design is a crossover AB BA. Treatment A consist in a cycle of blindsight training associated to tDCS, Treatment B consist in a a cycle of blindsight training alone.
During the blindsight training, the patient is asked to maintain central fixation and is exposed to visual stimuli in his blind hemifield. The patient task is detection and/or discrimination of stimuli.
During each session the patient is subjected to around 700 different stimuli variously associated in space and/or time.
One out of two blindsight training cycles is associated to tDCS treatment. Anodal tDCS is applied using a battery-driven constant current stimulator, and a pair of surface saline-soaked sponge electrodes (5 x 5 cm). Current intensity is of 2 mA (Fade-in/-out= 10 sec), for a total duration of 30 min. The stimulation start at the beginning of the rehabilitation session, and continue for 30 min, during treatment.
Anode is placed over the parieto-occipital cortex. The cathode is placed in the contralateral supraorbital position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is able to give his informed consent
- •Hemianopsia brain damage documented by means of TAC or RMN
- •Hemianopsia diagnosed by means automated visual field and Neurological Evaluation
- •Time from lesion at least six months
- •normal or corrected-to-normal visual acuity
排除标准
- •Presence of Ophthalmologic neuropsychologic or psychiatric pathology
- •Global cognitive deficit,
- •Presence of other neurological pathology
- •Presence of cardiac peacemaker
- •Presence metallic or electronic items in the head or in the body
- •Story/familiarity of epilepsy, taking medications that can induce epileptic crisis
- •Severe heart disease
- •History of high alcohol consumption
- •Pregnancy
结局指标
主要结局
Change in Humphrey visual field 30.2 SITA standard test
时间窗: 10 weeks and 20 weeks
次要结局
- Change in Schuhfried Vienna Test Peripheral Perception (PP-R)(10 weeks and 20 weeks)
- Change in Battery for Attentional Performance (TAP) subtest: Visual Field(10 weeks and 20 weeks)
- International Classification of Functioning (ICF)(20 weeks)