Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration
Effectiveness of TMS for Visual Restoration: a Multicenter Randomized Controlled Trial
1 other identifier
interventional
136
1 country
4
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 23, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2029
February 23, 2026
February 1, 2026
2 years
February 12, 2026
February 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Best-corrected visual acuity (BCVA) change
Baseline and 12 months
Other Outcomes (7)
Visual field progression
Baseline and 3 months
Contrast sensitivity function change
baseline and 3 months
Retinal structural alteration by fundus optical coherence tomography
Baseline and 3 months
- +4 more other outcomes
Study Arms (2)
TMS
EXPERIMENTALThe TMS group will receive theta burst stimulation targeting bilateral occipital visual cortex, with five consecutive daily sessions.
Control
SHAM COMPARATORThe control group will undergo identical procedures using a sham coil without effective magnetic field output.
Interventions
Transcranial magnetic stimulation targeting occipital visual cortex
identical procedure using a sham coil without effective magnetic field output
Eligibility Criteria
You may qualify if:
- between 45 and 70 years old
- bilateral severe MMD (META-PM grades ≥ 3)
- no prior TMS history or contraindications to TMS
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hong Kong Polytechnic University
Hong Kong, China
Eye and Ear, Nose, Throat Hospital of Fudan University
Shanghai, 200031, China
Huadong Hospital of Fudan University
Shanghai, China
Shanghai Ninth People's Hospital
Shanghai, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiangjia Zhu, PhD, MD
Eye and Ear, Nose, Throat Hospital of Fudan University
- PRINCIPAL INVESTIGATOR
Mingguang He
The Hong Kong Polytechnic 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
February 12, 2026
First Posted
February 23, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
May 31, 2028
Study Completion (Estimated)
May 31, 2029
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 1 year after publication and ending 3 years after the publication of results
- 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.
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.