Hemianopsia Clinical Trial
— HEMIANOTACSOfficial title:
Therapeutic Effects of Transcranial Alternative Current Stimulation (tACS) in Chronic Post Stroke Hemianopia
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 | Recruiting |
Enrollment | 36 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 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 |
Country | Name | City | State |
---|---|---|---|
France | GH Pitié Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Alekseichuk I, Diers K, Paulus W, Antal A. Transcranial electrical stimulation of the occipital cortex during visual perception modifies the magnitude of BOLD activity: A combined tES-fMRI approach. Neuroimage. 2016 Oct 15;140:110-7. doi: 10.1016/j.neuroimage.2015.11.034. Epub 2015 Nov 23. — View Citation
Helfrich RF, Knepper H, Nolte G, Struber D, Rach S, Herrmann CS, Schneider TR, Engel AK. Selective modulation of interhemispheric functional connectivity by HD-tACS shapes perception. PLoS Biol. 2014 Dec 30;12(12):e1002031. doi: 10.1371/journal.pbio.1002031. eCollection 2014 Dec. — View Citation
Sabel BA, Fedorov AB, Naue N, Borrmann A, Herrmann C, Gall C. Non-invasive alternating current stimulation improves vision in optic neuropathy. Restor Neurol Neurosci. 2011;29(6):493-505. doi: 10.3233/RNN-2011-0624. — View Citation
Sahraie A. Induced visual sensitivity changes in chronic hemianopia. Curr Opin Neurol. 2007 Dec;20(6):661-6. doi: 10.1097/WCO.0b013e3282f1c70f. — View Citation
Schuett S, Dauner R, Zihl J. Line bisection in unilateral homonymous visual field defects. Cortex. 2011 Jan;47(1):47-52. doi: 10.1016/j.cortex.2010.01.008. Epub 2010 Jan 28. — View Citation
Sergeeva EG, Henrich-Noack P, Bola M, Sabel BA. Brain-state-dependent non-invasive brain stimulation and functional priming: a hypothesis. Front Hum Neurosci. 2014 Nov 5;8:899. doi: 10.3389/fnhum.2014.00899. eCollection 2014. No abstract available. — View Citation
Zaehle T, Rach S, Herrmann CS. Transcranial alternating current stimulation enhances individual alpha activity in human EEG. PLoS One. 2010 Nov 1;5(11):e13766. doi: 10.1371/journal.pone.0013766. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the immediate effect of a single tACS session on the static visual field size of patients with chronic phase HH | 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 | Immediately after the intervention |
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