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NCT Number: NCT07425717

Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration

The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) works to restore vision in adults with severe retinal degeneration. It will also learn about the safety of TMS treatment. The main questions it aims to answer are:

1. Does TMS treatment improve the visual function of participants? 2. What medical problems do participants have when receiving TMS treatment? Researchers will compare TMS treatment to a sham stimulation (identical procedures using a sham coil without effective magnetic field output) to see if TMS treatment works to restore their vision.

Participants will:

UndergoTMS treatment to a sham stimulation for consecutive 5 days Visit the clinic at 5 days, 4 weeks, 3 months, 6 months, 12 months after start of the treatment for checkups and tests

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Key information

Conditions

Retinal Degeneration Blindness Eye Diseases Eye Diseases, Hereditary Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Diseases Sensation Disorders Signs and Symptoms Vision Disorders Vision Impairment and Blindness

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Polytechnic University, Hong Kong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • between 45 and 70 years old
  • bilateral severe MMD (META-PM grades ≥ 3)
  • no prior TMS history or contraindications to TMS

Exclusion criteria

  • other significant ocular diseases, such as refractive media opacity, glaucoma, uveitis, ocular trauma, untreated retinal detachment, or lens dislocation
  • received anti-vascular endothelial growth factor treatment or other ocular surgeries within 3 months
  • history of epilepsy or family history of epilepsy, intracranial metal implants, or severe cerebrovascular diseases
  • mental illness, cognitive impairment (MMSE score < 24), unable to communicate effectively
  • severe heart disease, liver or kidney dysfunction, or coagulation disorders
  • pregnant or lactating women
  • currently participating in other clinical trials.

Treatment and study plan

Transcranial magnetic stimulation targeting occipital visual cortex

Procedure

Transcranial magnetic stimulation targeting occipital visual cortex

Sham stimulation

Procedure

identical procedure using a sham coil without effective magnetic field output

Primary outcomes

  1. Best-corrected visual acuity (BCVA) change

    Time frame: Baseline and 3 months

    the change of best-corrected visual acuity (BCVA, measured by internationally standard EDTRS chart) between 3 months after the end of treatment and baseline

Secondary outcomes

  1. Best-corrected visual acuity (BCVA) change

    Time frame: Baseline and 12 months

    the change of BCVA (EDTRS) between 12 months after treatment and baseline

Other outcomes

  1. Visual field progression

    Time frame: Baseline and 3 months

    Visual field progression measured as mean defect (MD) from baseline to 3 months post-treatment

  2. Contrast sensitivity function change

    Time frame: baseline and 3 months

    Change in contrast sensitivity function from baseline to 3 months post-treatment

  3. Retinal structural alteration by fundus optical coherence tomography

    Time frame: Baseline and 3 months

    Retinal structural alteration measured by fundus optical coherence tomography from baseline to 3 months after treatment

  4. Change in scores of subjective questionnaire VFQ-25

    Time frame: baseline and 3 months

    Change in scores of subjective vision-related quality of life (VFQ-25) questionnaire from baseline to 3 months after treatment

  5. Change in scores of subjective questionnaire health-related quality of life (HRQL)

    Time frame: baseline and 3 months

    Change in scores of subjective health-related quality of life (HRQL) questionnaire from baseline to 3 months after treatment

  6. number of adverse events

    Time frame: baseline to 12 months

    the number of adverse events during 12-month follow-up

  7. the number of additional surgical interventions during 12-month follow-up

    Time frame: baseline and 12 months

Study contacts

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

Jiaqi Meng, MD

CONTACT

[email protected]

Xiangjia Zhu, PhD, MD

CONTACT

[email protected]

+0086-02164377134

Sponsors and collaborators

Lead sponsor

Shanghai High Myopia Study Group

Other

Registry information

Official study title

Effectiveness of TMS for Visual Restoration: a Multicenter Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

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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