ClinicalTrials.gg
Not yet recruitingNCT07425717Updated Feb 23, 2026

Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration

An interventional study of Transcranial magnetic stimulation targeting occipital visual cortex and Sham stimulation in Retinal Degeneration and Vision Impairment and Blindness, sponsored by Shanghai High Myopia Study Group. Not yet recruiting at 4 sites in China. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Shanghai High Myopia Study Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

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

02

Conditions studied

  • Retinal Degeneration
  • Vision Impairment and Blindness
03

In context

Retinal Degeneration

132 studies on the registry are indexed under Retinal Degeneration; 23 are open to participants now.

This study's planned enrollment of 136 is above the median of 40 across 98 interventional studies indexed under Retinal Degeneration.

Browse Retinal Degeneration studies →

Lead sponsor

Shanghai High Myopia Study Group is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 ( 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
136 participants (estimated)

Study arms

  • 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

  • Sham comparator
    Control

    The control group will undergo identical procedures using a sham coil without effective magnetic field output.

    Procedure: Sham stimulation

Interventions

  • ProcedureTranscranial magnetic stimulation targeting occipital visual cortex

    Transcranial magnetic stimulation targeting occipital visual cortex

  • ProcedureSham stimulation

    identical procedure using a sham coil without effective magnetic field output

06

What researchers measure

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

    Time frame: Baseline and 3 months

Secondary outcomes

  1. Best-corrected visual acuity (BCVA) change

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

    Time frame: Baseline and 12 months

Other outcomes

  1. Visual field progression

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

    Time frame: Baseline and 3 months

  2. Contrast sensitivity function change

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

    Time frame: baseline and 3 months

  3. Retinal structural alteration by fundus optical coherence tomography

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

    Time frame: Baseline and 3 months

  4. 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

    Time frame: baseline and 3 months

  5. 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

    Time frame: baseline and 3 months

  6. number of adverse events

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

    Time frame: baseline to 12 months

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

    Time frame: baseline and 12 months

07

Study locations

4 sites
  • Hong Kong Polytechnic University
    Hong Kong, China
    • Jiaqi Meng, MD · Contactjqmeng22@163.com · +0086-15221915385
    • Mingguang He, PhD · Principal investigator
  • Eye and Ear, Nose, Throat Hospital of Fudan University
    Shanghai, 200031, China
    • Jiaqi Meng, MD · Contactjqmeng22@163.com · +0086-02164377134
    • Jiaqi Meng, MD · Sub investigator
    • Xiangjia Zhu, PhD, MD · Principal investigator
    • Wenwen He, MD · Sub investigator
  • Huadong Hospital of Fudan University
    Shanghai, China
    • Rong Wu, MD · Contactalicewen@139.com · +0086-13636624399
    • Rong Wu, MD · Principal investigator
  • Shanghai Ninth People's Hospital
    Shanghai, China
    • Bo Ma, MD · Contactboma1983@hotmail.com · +0086-13701749192
    • Bo Ma, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07425717
Lead sponsor
Shanghai High Myopia Study Group
Responsible party
Xiangjia Zhu (PhD, MD, Shanghai High Myopia Study Group) — Principal investigator
First posted
Feb 23, 2026
Start date
Jun 1, 2026 (estimated)
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
Feb 23, 2026

Study contacts

Xiangjia Zhu, PhD, MD
Contact
zhuxiangjia1982@126.com
+0086-02164377134
Jiaqi Meng, MD
Contact
jqmeng22@163.com
Xiangjia Zhu, PhD, MD
principal investigator · Eye and Ear, Nose, Throat Hospital of Fudan University
Mingguang He
principal investigator · The Hong Kong Polytechnic University
Rong Wu
principal investigator · Huadong Hospital of Fudan University
Bo Ma
principal investigator · Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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