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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS | Experimental | The TMS group will receive theta burst stimulation targeting bilateral occipital visual cortex, with five consecutive daily sessions. |
|
| Control | Sham Comparator | The control group will undergo identical procedures using a sham coil without effective magnetic field output. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial magnetic stimulation targeting occipital visual cortex | Procedure | Transcranial magnetic stimulation targeting occipital visual cortex |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected visual acuity (BCVA) change | the change of BCVA (EDTRS) between 12 months after treatment and baseline | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual field progression | Visual field progression measured as mean defect (MD) from baseline to 3 months post-treatment | Baseline and 3 months |
| Contrast sensitivity function change | Change in contrast sensitivity function from baseline to 3 months post-treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangjia Zhu, PhD, MD | Contact | +0086-02164377134 | zhuxiangjia1982@126.com | |
| Jiaqi Meng, MD | Contact | jqmeng22@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangjia Zhu, PhD, MD | Eye and Ear, Nose, Throat Hospital of Fudan University | Principal Investigator |
| Mingguang He | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Polytechnic University | Hong Kong | China |
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.
Beginning 1 year after publication and ending 3 years after the publication of results
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.
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| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D014786 | Vision Disorders |
| D001766 | Blindness |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D012164 | Retinal Diseases |
| D012678 | Sensation Disorders |
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| Sham stimulation | Procedure | identical procedure using a sham coil without effective magnetic field output |
|
| baseline and 3 months |
| Retinal structural alteration by fundus optical coherence tomography | Retinal structural alteration measured by fundus optical coherence tomography from baseline to 3 months after treatment | Baseline and 3 months |
| 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 | baseline and 3 months |
| 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 | baseline and 3 months |
| number of adverse events | the number of adverse events during 12-month follow-up | baseline to 12 months |
| the number of additional surgical interventions during 12-month follow-up | baseline and 12 months |
| Rong Wu |
| Huadong Hospital of Fudan University |
| Principal Investigator |
| Bo Ma | Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University | Principal Investigator |
| 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 |
|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |