Evaluation on Visual Outcome of TMS

NCT ID: NCT06612190

Last Updated: 2024-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-10-31

Brief Summary

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The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients with visual impairment. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients who suffer from visual impairment? Researchers will compare TMS to the control group who will not receive effective TMS treatment) to see if TMS works to improve the visual outcomes of the patients.

Participants will

* Undergo TMS treatment or no effective TMS for consecutive 5 days.
* Visit the clinic once every 2 weeks for checkups and tests.

Detailed Description

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Conditions

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Visual Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TMS

Group Type EXPERIMENTAL

TMS

Intervention Type PROCEDURE

TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.

Control

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

The sham group will be given no real magnetic stimulation.

Interventions

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TMS

TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.

Intervention Type PROCEDURE

Control

The sham group will be given no real magnetic stimulation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Post cataract surgery or clear lens
* Best-corrected visual acuity less than 0.1logMAR

Exclusion Criteria

* Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
* Diagnosed with ocular diseases that affect observation of visual function;
* History of epileptic seizures;
* Long term use of psychotropic drugs;
* Metal implants in the body.
Minimum Eligible Age

6 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evidence Based Cataract Study Group

OTHER

Sponsor Role lead

Responsible Party

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xiangjiazhu

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiangjia Zhu

Role: STUDY_CHAIR

Eye and ENT Hospital of Fudan University

Yating Tang

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Yinglei Zhang

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Jiaqi Meng

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Xin Liu

Role: PRINCIPAL_INVESTIGATOR

Eye and ENT Hospital of Fudan University

Locations

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Eye and Ear, Nose Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Xiangjia Zhu

Role: CONTACT

0086+02164377134

Facility Contacts

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Xiangjia Zhu

Role: primary

0086+02164377134

Other Identifiers

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EBCSG2024015

Identifier Type: -

Identifier Source: org_study_id

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