Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration

N/ANot Yet RecruitingNCT07425717

Shanghai High Myopia Study Group136 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

136

Conditions

Retinal Degeneration Vision Impairment and Blindness

Interventions

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (4)

Hong Kong Polytechnic University

Hong Kong, China

Eye and Ear, Nose, Throat Hospital of Fudan University

Shanghai, China

Huadong Hospital of Fudan University

Shanghai, China

Shanghai Ninth People's Hospital

Shanghai, China

Outcomes

Primary Outcomes

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

Time frame: Baseline and 3 months

Secondary Outcomes

Best-corrected visual acuity (BCVA) change

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

Time frame: Baseline and 12 months

Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts