NCT04043689Completed
Therapeutic Effects of Transcranial Alternative Current Stimulation (tACS) in Chronic Post Stroke Hemianopia
Source: ClinicalTrials.gov · Last updated 8 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 25 Jul 2019
- Start date
- 22 Dec 2020
- Primary completion date
- 3 Apr 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Stroke
- NCT number
- NCT04043689
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 22 Dec 2020 to the primary completion date, 3 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gh Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.