Retinal DegenerationNCT07425717
Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration
A study testing Transcranial magnetic stimulation targeting occipital visual cortex in people with Retinal Degeneration and Vision Impairment and Blindness, run by Shanghai High Myopia Study Group at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Retinal Degeneration, Vision Impairment and Blindness
- What is being tested?
- Transcranial magnetic stimulation targeting occipital visual cortex
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jun 2026to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 45 and 70 years old
- bilateral severe MMD (META-PM grades ≥ 3)
- no prior TMS history or contraindications to TMS
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jiaqi Meng, MD contact
China4 sites
Hong Kong Polytechnic University
Hong Kong
Jiaqi Meng, MD, +0086-15221915385, jqmeng22@163.com
Mingguang He, PhD
Eye and Ear, Nose, Throat Hospital of Fudan University
Shanghai, 200031
Jiaqi Meng, MD, +0086-02164377134, jqmeng22@163.com
Jiaqi Meng, MD
Huadong Hospital of Fudan University
Shanghai
Rong Wu, MD, +0086-13636624399, alicewen@139.com
Rong Wu, MD
Shanghai Ninth People's Hospital
Shanghai
Bo Ma, MD, +0086-13701749192, boma1983@hotmail.com
Bo Ma, MD
About this study
Official title: 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:
- Does TMS treatment improve the visual function of participants?
- 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.
Read more
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
- Being tested
- Transcranial magnetic stimulation targeting occipital visual cortex, Sham stimulation
- Medical subject headings
- Retinal Degeneration, Vision Disorders, Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial magnetic stimulation targeting occipital visual cortexProcedure or surgery
Transcranial magnetic stimulation targeting occipital visual cortex
Sham stimulationProcedure or surgery
identical procedure using a sham coil without effective magnetic field output
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | The TMS group will receive theta burst stimulation targeting bilateral occipital visual cortex, with five consecutive daily sessions. Receives: Procedure: Transcranial magnetic stimulation targeting occipital visual cortex |
| Control | Sham comparator | The control group will undergo identical procedures using a sham coil without effective magnetic field output. Receives: Procedure: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai High Myopia Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangjia Zhu, Shanghai High Myopia Study Group
- Investigators
- Xiangjia Zhu, PhD, MD, Principal investigator, Eye and Ear, Nose, Throat Hospital of Fudan UniversityMingguang He, Principal investigator, The Hong Kong Polytechnic UniversityRong Wu, Principal investigator, Huadong Hospital of Fudan UniversityBo Ma, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425717
- Sponsor's protocol ID
- SHDC12026129
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TMS for Visual Restoration: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07425717
- Acronym / sponsor ID
- SHDC12026129
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Shanghai High Myopia Study GroupUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does TMS treatment improve the visual function of participants?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Procedure: Transcranial magnetic stimulation targeting occipital visual cortexThe TMS group will receive theta burst stimulation targeting bilateral occipital visual cortex, with five consecutive daily sessions. |
| Control | Sham comparator | Procedure: Sham stimulationThe control group will undergo identical procedures using a sham coil without effective magnetic field output. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 45 and 70 years old
- bilateral severe MMD (META-PM grades ≥ 3)
- no prior TMS history or contraindications to TMS
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial magnetic stimulation targeting occipital visual cortexTranscranial magnetic stimulation targeting occipital visual cortex | Procedure or surgery | TMS |
| Sham stimulationidentical procedure using a sham coil without effective magnetic field output | Procedure or surgery | Control |
Primary outcome
Best-corrected visual acuity (BCVA) change
Time frame: Baseline and 3 months
the change of best-corrected visual acuity (BCVA, measured by internationally standard EDTRS chart) between 3 months after the end of treatment and baseline
1 secondary outcome
Best-corrected visual acuity (BCVA) change
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiaqi Meng, MD contact
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial magnetic stimulation targeting occipital visual cortex in people with Retinal Degeneration and Vision Impairment and Blindness, run by Shanghai High Myopia Study Group at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangjia Zhu, PhD, MD (+0086-02164377134, zhuxiangjia1982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected visual acuity (BCVA) change (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.