Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Retinal Degeneration; Vision Impairment and Blindness
• Intervention / Treatment: Procedure: Transcranial magnetic stimulation targeting occipital visual cortex; Procedure: Sham stimulation

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangjia Zhu, PhD, MD; Phone Number: +0086-02164377134; Email: zhuxiangjia1982@126.com
• Study Contact Backup: Name: Jiaqi Meng, MD; Email: jqmeng22@163.com

Study Locations

• China
  • Hong Kong, China
    • Hong Kong Polytechnic University
    • Principal Investigator: Mingguang He, PhD
    • Contact: Jiaqi Meng, MD; Phone Number: +0086-15221915385; Email: jqmeng22@163.com
  • Shanghai, China
    • Shanghai Ninth People's Hospital
    • Contact: Bo Ma, MD; Phone Number: +0086-13701749192; Email: boma1983@hotmail.com
    • Principal Investigator: Bo Ma, MD
  • Shanghai, China
    • Huadong Hospital of Fudan University
    • Contact: Rong Wu, MD; Phone Number: +0086-13636624399; Email: alicewen@139.com
    • Principal Investigator: Rong Wu, MD
  • Shanghai, China, 200031
    • Eye and Ear, Nose, Throat Hospital of Fudan University
    • Contact: Jiaqi Meng, MD; Phone Number: +0086-02164377134; Email: jqmeng22@163.com
    • Sub-Investigator: Jiaqi Meng, MD
    • Principal Investigator: Xiangjia Zhu, PhD, MD
    • Sub-Investigator: Wenwen He, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TMS; The TMS group will receive theta burst stimulation targeting bilateral occipital visual cortex, with five consecutive daily sessions.	Procedure: Transcranial magnetic stimulation targeting occipital visual cortex; Transcranial magnetic stimulation targeting occipital visual cortex
Sham Comparator: Control; The control group will undergo identical procedures using a sham coil without effective magnetic field output.	Procedure: Sham stimulation; identical procedure using a sham coil without effective magnetic field output

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected visual acuity (BCVA) change	the change of best-corrected visual acuity (BCVA, measured by internationally standard EDTRS chart) between 3 months after the end of treatment and baseline	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-corrected visual acuity (BCVA) change	the change of BCVA (EDTRS) between 12 months after treatment and baseline	Baseline and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual field progression	Visual field progression measured as mean defect (MD) from baseline to 3 months post-treatment	Baseline and 3 months
Contrast sensitivity function change	Change in contrast sensitivity function from baseline to 3 months post-treatment	baseline and 3 months
Retinal structural alteration by fundus optical coherence tomography	Retinal structural alteration measured by fundus optical coherence tomography from baseline to 3 months after treatment	Baseline and 3 months
Change in scores of subjective questionnaire VFQ-25	Change in scores of subjective vision-related quality of life (VFQ-25) questionnaire from baseline to 3 months after treatment	baseline and 3 months
Change in scores of subjective questionnaire health-related quality of life (HRQL)	Change in scores of subjective health-related quality of life (HRQL) questionnaire from baseline to 3 months after treatment	baseline and 3 months
number of adverse events	the number of adverse events during 12-month follow-up	baseline to 12 months
the number of additional surgical interventions during 12-month follow-up		baseline and 12 months

Collaborators and Investigators

• Sponsor: Shanghai High Myopia Study Group
• Investigators: Principal Investigator: Mingguang He, The Hong Kong Polytechnic University; Principal Investigator: Xiangjia Zhu, PhD, MD, Eye and Ear, Nose, Throat Hospital of Fudan University; Principal Investigator: Rong Wu, Huadong Hospital of Fudan University; Principal Investigator: Bo Ma, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2029

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Eye Diseases, Hereditary; Sensation Disorders; Retinal Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Retinal Degeneration; Blindness; Vision Disorders
• Other Study ID Numbers: SHDC12026129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified raw study data eligible for secondary analysis will be made available, including baseline characteristics, outcome measures, adverse events (AEs) and group allocation information.
• IPD Sharing Time Frame: Beginning 1 year after publication and ending 3 years after the publication of results
• IPD Sharing Access Criteria: Investigators who need to use the data for secondary analysis must provide a proposal that describes planned analyses and sign data sharing agreement after the principal investigators approve the proposals.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No