Therapeutic Effects of Transcranial Alternative Current Stimulation (tACS) in Chronic Post Stroke Hemianopia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- To evaluate the immediate effect of a single tACS session on the static visual field size of patients with chronic phase HH
研究概览
简要总结
Background: The most common visual field deficit after retro-chiasmatic lesions is homonymous hemianopia (HH), defined as the impossibility of seeing the contralesional visual hemisphere without ocular injury. HH affects between 90000 and 120 000 new cases per year in the United States and Europe HH was reported in 30% of patients after stroke (National Audit Office) (in France, with 130,000 strokes per year, 39,000 patients with HH). Despite the 30-year decline, the rehabilitation techniques have a low level of evidence of their effectiveness and few are used in routine clinical practice in France.
Transcranial Alternate Current Stimulation (tACS) is a method of Alternative Current stimulation that can modulate neural activity by imposing local oscillatory activity.
An observational study of occipital tACS in patients with optic nerve lesions showed an increase in visual field size, power, and occipital alpha synchrony. Two transorbital tACS studies showed visual improvements , and compensations for abnormally weak oscillatory activity by temporal resynchronization. Our team has demonstrated a role of noninvasive brain stimulation in right hemisphere frontal eye fields on cortical beta-high (~ 30 Hz) oscillatory activity, improving the visual perception of both hemi-fields and the fronto-parietal synchrony of the right hemisphere.
Objective:
This project aims to compare, on the same patient population, two tACS stimulation strategies, with the aim of increasing the attentional orientation towards the blind visual hemi-field and thus the visual detection of stimuli in this hemi-field. .
For this, The investigator team will evaluate on the one hand an occipital stimulation (V1-IPS) contralateral to the lesion, at a alfa frequency (10 Hz), which induces the desynchronization of the contralateral hemisphere with the aim of improving the visual perception of targets in the blind visual hemi-field. the study will compare this intervention to a stimulation of the frontal region (FEF) of the right hemisphere at a high-beta frequency (30 Hz), which showed effects of facilitation of endogenous and exogenous attentional orientation. The two previous strategies will be compared to a placebo tACS stimulation session.
详细描述
Background:
Focusing on low-level perceptual activities, and robust, controlled explorations with medium-sized cohorts, several studies have shown tACS effects related to oscillatory activity and inter-regional synchrony.
For example, in healthy subjects, occipital tACS showed an increase in posterior alpha power following tACS alpha (10-14 Hz). At higher frequencies, the 60 Hz tACS showed a sustained reduction in visual contrast sensitivity threshold . Two studies in 2014 have also shown following 40 Hz tACS stimulation of occipital or parietal brain regions in healthy humans, sustained dependent on synchrony of posterior interhemispheric gamma band networks, and modulation effects of moving target perception Very recently, a 10 Hz occipital tACS stimulation study coupled with functional magnetic resonance Imaging recording (fMRI) showed diffuse effects likely to indicate occipito-parieto-temporal synchronization during the delayed phase of effects.
Among patients' trials, an observational study of uncontrolled occipital tACS in patients with optic nerve lesions showed improved visual acuity and visual field size, accompanied by an increase in power and of occipital alpha synchrony by targeting periorbital regions; More recently, a double-blind, multicenter, controlled trial in patients with optic nerve lesions showed, with daily transorbital tACS sessions lasting 10 weeks, a sustained (2.5%) increase in visual field size versus stimulation placebo.
This project aims to compare, on the same patient population, two tACS stimulation strategies, with the aim of increasing the attentional orientation towards the blind visual hemi-field and thus the visual detection of stimuli in this hemi-field. .
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient aged 18 and over
- •Patient with homonymous lateral hemianopia with brain injury acquired for at least 3 months and at most 10 years after ischemic stroke, cerebral hematoma
- •Patient able to understand French both orally and in writing
- •Patient giving free, informed and written consent
- •Absence of a neurological disease interfering with the passing of tests
- •Non-inclusion criteria :
- •Patients subject to a legal protection measure (safeguarding of justice, guardianship and trusteeship, protected adults)
- •Pre-existing severe ophthalmological disorders, visual field disorders visual field disorders, monocular visual acuity less than 5/10, severe oculomotor disorders (post-stroke ophthalmological consultation less than at the time of inclusion)
- •Contraindication of tACS and / or magnetic resonance imaging (pacemaker or implantable defibrillator, intracranial electrodes or other intracranial implant, cranial vault anomalies facing stimulation electrodes (plates, prostheses, uncovered skull)
- •Pregnant women and nursing mothers
- •Recruitment in other interventional studies for the duration of the participation.
- •Non-affiliation to a social security scheme (excluding AME) or non-beneficiary of such a scheme
- •Healthy participants inclusion criteria are the following:
- •Healthy Subject 18 years and older
- •Healthy subject able to understand French both orally and in writing
- •Healthy subject who has given free and informed consent and writes
- •Healthy participants non-inclusion criteria are the following:
- •Severe neurological, psychiatric, physical, or ophthalmological disorders (binocular visual acuity less than 5/10, ophthalmological consultation less than one year old at the time of inclusion) that interfere with the normal performance of tests and study tasks
- •Contraindication to magnetic resonance imaging (pacemaker or implantable defibrillator, intracranial electrodes or other intracranial implant, abnormalities of the cranial vault opposite stimulation electrodes (plates, prostheses, uncovered skull)
- •Recruitment in other interventional studies for the duration of the participation.
- •Pregnant women and nursing mothers
- •Non-affiliation to a social security scheme (excluding AME) or non-beneficiary of such a scheme
排除标准
- 未提供
研究组 & 干预措施
tACS stimulation of the right frontal region
Active tACS stimulation of the right frontal region (around the right FEF, EEG electrode FC2) at a high-beta frequency (30 Hz) with the goal of visibly training EEG recordings, frontal oscillatory activity and right fronto-parietal synchrony (FEF-IPS, or between FC2 and P4 electrodes) in the high-beta band (~ 30 Hz) which facilitates attentional orientation and visual perception in the two visual hemi-fields, but more particularly the targets present on the blind field of vision.
干预措施: tACS (transcranial Alternate Current Stimulation) (Device)
tACS stimulation of the occipito-parietal region
Active tACS stimulation of the occipito-parietal posterior contralesional region(around the right IPS, EEG electrode P4), at an alpha frequency (10 Hz) which will induce on the EEG recordings an oscillatory drive in the alpha band ( ~ 10Hz) and an increase in synchrony at this frequency band on the stimulated posterior occipital and parietal lobe (EEG electrodes P4 and 02), but also, by transcallosal push-and-pull phenomena, a desynchronization effect of the contralateral posterior occipital and parietal area (EEG electrodes P3 and 01), which will facilitate attention orientation and target detection in the blind visual field of view.
干预措施: tACS (transcranial Alternate Current Stimulation) (Device)
TACS stimulation of the right frontal (FEF)
. Condition TACS stimulation of the right frontal (FEF) at a high-beta frequency (30 Hz) for half of the patients and unilateral occipital cortex (right / left) at an alfa frequency (10 Hz) for the other half . This condition will control the possible placebo effects of tACS stimulation and the potential effects of visual field enhancement with repetition of perimetry tests. This condition will also verify the lack of changes in cerebral rhythm activity in the case of an application without effective electrical current.
干预措施: tACS (transcranial Alternate Current Stimulation) (Device)
结局指标
主要结局
To evaluate the immediate effect of a single tACS session on the static visual field size of patients with chronic phase HH
时间窗: Immediately after the intervention
To evaluate the immediate effect of a single tACS session, under two different conditions of tACS stimulation (right frontal stimulation (FEF, Frontal Eye Fields) and contralateral occipito-parietal stimulation to the lesion (V1-IPS, primary visual cortex and intraparietal sulcus or intra-parietal furrow) on the static visual field size of patients with chronic phase HH
次要结局
未报告次要终点