NCT05220449

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

5.9 years

First QC Date

November 30, 2021

Last Update Submit

August 27, 2024

Conditions

Keywords

StrokeVisual fieldOscillationstACSParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Changes in visual field functions

    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 Outcomes (4)

  • Changes in motion discrimination and integration performances

    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

    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

    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

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

Study Arms (2)

Cf-tACS (V1-Alpha_V5-Gamma)

ACTIVE COMPARATOR
Other: Cross-frequency dual-site tACS

Cf-tACS (V1-Gamma_V5-Alpha)

EXPERIMENTAL
Other: Cross-frequency dual-site tACS

Interventions

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)

Cf-tACS (V1-Alpha_V5-Gamma)Cf-tACS (V1-Gamma_V5-Alpha)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Use of psychoactive medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Biotech, EPFL

Geneva, 1201, Switzerland

Location

MeSH Terms

Conditions

Vision DisordersStrokeParkinson Disease

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Double (Participant \& Investigator)
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching and Research Associate

Study Record Dates

First Submitted

November 30, 2021

First Posted

February 2, 2022

Study Start

September 1, 2017

Primary Completion

August 1, 2023

Study Completion

December 1, 2025

Last Updated

August 28, 2024

Record last verified: 2024-08

Locations