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NCT Number: NCT06612190

Evaluation on Visual Outcome of TMS

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.

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Key information

Conditions

Visual Impairment Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

6 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eye and Ear, Nose Throat Hospital of Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location contact

Xiangjia Zhu

CONTACT

[email protected]

0086+02164377134

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMS

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

Procedure

The sham group will be given no real magnetic stimulation.

Primary outcomes

  1. Visual acuity

    Time frame: From enrollment to the end of treatment at 6 months

Secondary outcomes

  1. Visual field

    Time frame: From enrollment to the end of treatment at 6 months

Other outcomes

  1. Visual quality

    Time frame: From enrollment to the end of treatment at 6 months

    Include objective visual quality (contrast sensitivity) and subjective visual quality (visual function questionnaire score).

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangjia Zhu

CONTACT

[email protected]

0086+02164377134

Sponsors and collaborators

Lead sponsor

Evidence Based Cataract Study Group

Other

Registry information

Official study title

Evaluation on Visual Outcome of Transcranial Magnetic Stimulation

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Sep 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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