Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial magnetic stimulation targeting occipital visual cortex, Sham stimulation.
- Who it may be relevant to
- Registry conditions: Retinal Degeneration, Vision Impairment and Blindness. Basic parameters: 45 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effectiveness of TMS for Visual Restoration: a Multicenter Randomized Controlled Trial
Overview
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
Interventions
- Procedure Transcranial magnetic stimulation targeting occipital visual cortex
Transcranial magnetic stimulation targeting occipital visual cortex - Procedure Sham stimulation
identical procedure using a sham coil without effective magnetic field output
Primary outcome measures
- Best-corrected visual acuity (BCVA) change [Time frame: Baseline and 3 months]
Secondary outcome measures (1)
- Best-corrected visual acuity (BCVA) change [Time frame: Baseline and 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 4 centers
- Hong Kong Polytechnic University — Hong Kong
- Eye and Ear, Nose, Throat Hospital of Fudan University — Shanghai
- Huadong Hospital of Fudan University — Shanghai
- Shanghai Ninth People's Hospital — Shanghai
Identifiers
NCT: NCT07425717 · SHDC12026129