NCT03151200

Brief Summary

The purpose of this study is to assess the effectiveness of combining binocular treatment with repetitive transcranial magnetic stimulation (rTMS) in improving the vision of adults with amblyopia. This study also seeks to assess the effect of this combined treatment on cortical neural function and functional connectivity.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 26, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 10, 2023

Status Verified

October 1, 2018

Enrollment Period

6.8 years

First QC Date

October 26, 2015

Last Update Submit

May 8, 2023

Conditions

Amblyopia

Keywords

Amblyopia treatment

Outcome Measures

Primary Outcomes (1)

  • Improvement of visual acuity in amblyopic eyes after TMS/binocular treatment

    2 weeks treatment

Secondary Outcomes (1)

  • Improvement of stereovision and reduction in suppression in amblyopic patients after TMS/binocular treatment

    2 weeks treatment

Other Outcomes (1)

  • Brain function and connectivity changes after TMS/binocular treatment

    2 weeks treatment

Study Arms (2)

binocular treatment

ACTIVE COMPARATOR

Active treatment group will receive five days of one hour visual binocular training by playing a specifically designed falling blocks video game on a computer screen that will be individually calibrated for each person with red-green glasses with treatment effect.

Device: Computer based binocular treatmentDevice: Transcranial magnetic stimulation

sham treatment

SHAM COMPARATOR

Sham treatment group will receive five days of one hour sham visual binocular training by playing a specially designed falling blocks video game on a computer screen with polarized glasses with no treatment effect.

Device: Transcranial magnetic stimulation

Interventions

Computer based binocular treatmentDEVICE

Binocular amblyopia treatment involves presenting stimuli over a computer screen to the amblyopic eye those are at higher contrast compared to the stimuli that are presented to the good eye, which balances the performances of the two eyes and over time improves the amblyopic eye vision.

binocular treatment
Transcranial magnetic stimulationDEVICE

TMS is a non-invasive research method that generates electrical current at the cortex that can excite neuronal activities and neuronal plasticity.

Also known as: TMS
binocular treatmentsham treatment

Eligibility Criteria

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

You may qualify if:

  • A total of 20 strabismic or mixed amblyopic adult patients (eighteen or older) will be recruited from Dr. Mansouri's practice. Patients will be asked for their permission to be contacted by a research assistant with regard to the study. A research assistant will then contact patients and inform them about the study, its procedures, and its voluntary nature. Patients will not be contacted without their previous permission.

You may not qualify if:

  • Given the use of rTMS and MRI in this study, participants will be excluded if they have any contraindications to these procedures. Contraindications include: the presence of metal clips or implants in the body (such as pacemakers, defibrillators or neural stimulators), metallic dental work, severe claustrophobia, epilepsy, a family history of seizures, or the taking of epileptogenic medications. Pregnant individuals will also be excluded as a precaution.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VGH Adult Medical Clinic

Winnipeg, Manitoba, R3T 2H5, Canada

Location

MeSH Terms

Conditions

Amblyopia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2015

First Posted

May 12, 2017

Study Start

January 30, 2014

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 10, 2023

Record last verified: 2018-10

Locations

CA(1)