Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery (R4V)

August 27, 2024 updated by: Estelle Raffin, Ecole Polytechnique Fédérale de Lausanne

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1201
        • Campus Biotech, EPFL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cf-tACS (V1-Alpha_V5-Gamma)
Other: Cross-frequency dual-site tACS
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)
Experimental: Cf-tACS (V1-Gamma_V5-Alpha)
Other: Cross-frequency dual-site tACS
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
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
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
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
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
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
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ecole Polytechnique Fédérale de Lausanne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

August 1, 2023

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 28, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-01761

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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