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

Primary Purpose

Visual Impairment, Stroke, Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Cross-frequency dual-site tACS
Sponsored by
Ecole Polytechnique Fédérale de Lausanne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Visual Impairment focused on measuring Stroke, Visual field, Oscillations, tACS, Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Campus Biotech, EPFLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cf-tACS (V1-Alpha_V5-Gamma)

Cf-tACS (V1-Gamma_V5-Alpha)

Arm Description

Outcomes

Primary Outcome Measures

Changes in visual field functions
Comparison of the systematic measurement of the visual field using Humphrey perimetry

Secondary Outcome Measures

Changes in motion discrimination and integration performances
Comparison of the motion coherence threshold extracted from a two forced-choice direction discrimination task
Changes in inter-areal cross-frequency interaction
Comparison of the inter-areal Alpha-Gamma coupling using electroencephalography recordings
Changes in visual tracts integrity
Comparison of the diffusion weigted imaging-based tractography of the main visual tracts
Changes in functional connectivity within the broad visual network
Functional MRI based connectivity analyses using DCM or graph theory will perfomed

Full Information

First Posted
November 30, 2021
Last Updated
January 27, 2022
Sponsor
Ecole Polytechnique Fédérale de Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT05220449
Brief Title
Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery
Acronym
R4V
Official Title
Individualized Brain Stimulation to Improve Functional Rehabilitation in Two Models of Sensorimotor Disorders: Stroke and Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ecole Polytechnique Fédérale de Lausanne

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Stroke, Parkinson Disease
Keywords
Stroke, Visual field, Oscillations, tACS, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Masking Description
Double (Participant & Investigator)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cf-tACS (V1-Alpha_V5-Gamma)
Arm Type
Active Comparator
Arm Title
Cf-tACS (V1-Gamma_V5-Alpha)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cross-frequency dual-site tACS
Intervention Description
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 Outcome Measure Information:
Title
Changes in visual field functions
Description
Comparison of the systematic measurement of the visual field using Humphrey perimetry
Time Frame
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Secondary Outcome Measure Information:
Title
Changes in motion discrimination and integration performances
Description
Comparison of the motion coherence threshold extracted from a two forced-choice direction discrimination task
Time Frame
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Title
Changes in inter-areal cross-frequency interaction
Description
Comparison of the inter-areal Alpha-Gamma coupling using electroencephalography recordings
Time Frame
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Title
Changes in visual tracts integrity
Description
Comparison of the diffusion weigted imaging-based tractography of the main visual tracts
Time Frame
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)
Title
Changes in functional connectivity within the broad visual network
Description
Functional MRI based connectivity analyses using DCM or graph theory will perfomed
Time Frame
Measured at baseline (i.e. before the first day of intervention), and post intervention (i.e., after the last day of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle Raffin, PhD
Phone
0216955185
Ext
+41
Email
estelle.raffin@epfl.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Friedhelm Hummel, Professor
Email
friedhelm.hummel@epfl.ch
Facility Information:
Facility Name
Campus Biotech, EPFL
City
Geneva
ZIP/Postal Code
1201
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline Stehli, Msc

12. IPD Sharing Statement

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Re-Orchestration of Interregional Oscillatory Activity to Promote Visual Recovery

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