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Active, Not Recruiting

NCT Number: NCT05220449

Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery

This project assesses the effect of bifocal cross-frequency transcranial alternating current stimulation (tACS) combined with visual training to improve visual recovery and orchestrated oscillatory activity in stroke patients suffering from visual field defects.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Visual Impairment Basal Ganglia Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stroke Synucleinopathies Vascular Diseases Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Biotech, EPFL

Geneva, 1201, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the patient can consent for themselves;
  • age 18+ years old;
  • at least 7 days since diagnosis "stroke".
  • Patients should demonstrate a clear deficit in either simple or complex visual perception in portions of their visual field

Exclusion criteria

  • Diminished capacity to consent;
  • Pregnancy
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant,
  • Non-compliance to the instructions of the experimenter or an inappropriate behavior hindering the normal progress of the experiment.
  • Previous enrolment into the current study
  • Exclusion criteria of MRI, tACS, TMS
  • Use of psychoactive medication

Treatment and study plan

Cross-frequency dual-site tACS

Other

Dual site transcranial alternating current stimulation over the primary visual cortex (V1) and the mediotemporal cortex (MT/V5) using two different stimulation frequencies (Alpha and Gamma)

Primary outcomes

  1. Changes in visual field functions

    Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

    Comparison of the systematic measurement of the visual field using Humphrey perimetry

Secondary outcomes

  1. Changes in motion discrimination and integration performances

    Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

    Comparison of the motion coherence threshold extracted from a two forced-choice direction discrimination task

  2. Changes in inter-areal cross-frequency interaction

    Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

    Comparison of the inter-areal Alpha-Gamma coupling using electroencephalography recordings

  3. Changes in visual tracts integrity

    Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

    Comparison of the diffusion weigted imaging-based tractography of the main visual tracts

  4. Changes in functional connectivity within the broad visual network

    Time frame: Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

    Functional MRI based connectivity analyses using DCM or graph theory will perfomed

Sponsors and collaborators

Lead sponsor

Ecole Polytechnique Fédérale de Lausanne

Other

Registry information

Official study title

Individualized Brain Stimulation to Improve Functional Rehabilitation in Two Models of Sensorimotor Disorders: Stroke and Parkinson's Disease

Acronym: R4V

Important dates

Study start
2017
Primary completion
2023
Study completion
2025
First posted
Feb 2, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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