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Trial record 29 of 917 for:    triamcinolone acetonide

Therapeutic Effects of Transcranial Alternative Current Stimulation (tACS) in Chronic Post Stroke Hemianopia (HEMIANOTACS)

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ClinicalTrials.gov Identifier: NCT04043689
Recruitment Status : Not yet recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hemianopsia Device: tACS (transcranial Alternate Current Stimulation) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Transcranial Alternative Current Stimulation (tACS) in Chronic Post Stroke Hemianopia
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: tACS (transcranial Alternate Current Stimulation)

This is a single-centric comparative randomized controlled blind and cross-over study.

The order of stimulation conditions will be randomized: (right frontal tACS / occipital tACS / tACS PLACEBO). The 3 stimulation conditions will be performed with a wash-out period of at least 1 week. In this study each patient will be his own control


Active Comparator: 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.
Device: tACS (transcranial Alternate Current Stimulation)

This is a single-centric comparative randomized controlled blind and cross-over study.

The order of stimulation conditions will be randomized: (right frontal tACS / occipital tACS / tACS PLACEBO). The 3 stimulation conditions will be performed with a wash-out period of at least 1 week. In this study each patient will be his own control


Sham Comparator: 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.
Device: tACS (transcranial Alternate Current Stimulation)

This is a single-centric comparative randomized controlled blind and cross-over study.

The order of stimulation conditions will be randomized: (right frontal tACS / occipital tACS / tACS PLACEBO). The 3 stimulation conditions will be performed with a wash-out period of at least 1 week. In this study each patient will be his own control





Primary Outcome Measures :
  1. To evaluate the immediate effect of a single tACS session on the static visual field size of patients with chronic phase HH [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patient aged 18 and over

  • Patient with homonymous lateral hemianopia with brain injury acquired for at least 3 months and at most 5 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 (ophthalmic consultation before inclusion) pre-existing visual field defects, monocular visual acuity less than 5/10, severe oculomotor disorders
  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04043689


Contacts
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Contact: Alexia POTET, MD 142161149 ext +33 alexia.potet@aphp.fr
Contact: Antoni VALERO-CABRÉ 157274163 ext +33 antoni.valerocabre@icm-institute.org

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Publications:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04043689     History of Changes
Other Study ID Numbers: APHP 190051
2019-A00501-56 ( Other Identifier: N°IDRCB )
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemianopsia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Blindness
Eye Diseases
Signs and Symptoms