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临床试验/NCT03151200
NCT03151200撤回不适用

Visual Functional Connectivity and Visual Function in Amblyopia Before and After TMS and/or Binocular Treatment

University of Manitoba2 个研究点 分布在 1 个国家开始时间: 2014年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Improvement of visual acuity in amblyopic eyes after TMS/binocular treatment

研究概览

简要总结

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.

详细描述

Prior to the study, ocular misalignment and refraction abnormalities will be corrected This correction is part of standard patient care rather than a procedural component of the current study.

Procedure Participants will undergo one hour structural and functional MRI prior to their treatment. We will perform an interim analysis of the fMRI results once five amblyopic patients have completed the fMRI study. If the data shows significant differences in the resting state visual network in amblyopia patients compared to the existing normal visual resting state, we will pursue the fMRI study with the remaining 15 participants. Misalignment of the eyes will be corrected prior to a patients' participation by using prisms (if medically indicated). This correction is part of standard patient care rather than a procedural component of the current study. Participants will be randomly appointed to initially be in either the sham or the treatment group (10 patients in each group). All patients will receive five days of one hour visual binocular training by playing a specially designed falling blocks videogame on a computer screen that will be individually calibrated for each person. Group one will receive 18 minutes of rTMS at the beginning of their visual training every day for 5 days. Group two will receive 18 minutes of TMS followed by sham visual training every day for 5 days. At the end of five days, participants will switch groups. Participants will be blind as to whether they receive sham or real binocular treatment on each occasion.

A sensorimotor visual profile, including visual acuity, suppression, stereovision, binocularity, contrast sensitivity and eye alignment, will be completed for each patient at baseline, after five sessions, and at the end of the treatment. This profile will be completed using the PVVAT system, Worth-4-Dot test, Randot stereovision test, anaglyphic dichoptic coherence motion threshold with red-green glasses (using Psykinematix vision system), cross cover test with prism bars. fMRI will be repeated post-treatment only for individuals who showed abnormal fMRI at baseline. This second scan will investigate whether the treatment affected and normalized the resting state visual network.

Functional MRI:

All scanning will be performed on a 3.0 T Siemens Tim Trio scanner equipped with a 12-channel head coil. Scanning will take place on up to three visits: Pre-treatment (retinotopic mapping), and two post treatment scans.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 2 weeks treatment

次要结局

  • Improvement of stereovision and reduction in suppression in amblyopic patients after TMS/binocular treatment(2 weeks treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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