Evaluation on Visual Outcome of TMS
1 other identifier
interventional
300
1 country
1
Brief Summary
The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients with visual impairment. The main question it aims to answer is:
- Does TMS improve the visual outcome in patients who suffer from visual impairment? Researchers will compare TMS to the control group who will not receive effective TMS treatment) to see if TMS works to improve the visual outcomes of the patients. Participants will
- Undergo TMS treatment or no effective TMS for consecutive 5 days.
- Visit the clinic once every 2 weeks for checkups and tests.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2024
CompletedFirst Posted
Study publicly available on registry
September 25, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2027
ExpectedSeptember 25, 2024
September 1, 2024
1 year
September 21, 2024
September 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity
From enrollment to the end of treatment at 6 months
Secondary Outcomes (1)
Visual field
From enrollment to the end of treatment at 6 months
Other Outcomes (1)
Visual quality
From enrollment to the end of treatment at 6 months
Study Arms (2)
TMS
EXPERIMENTALControl
SHAM COMPARATORInterventions
TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.
Eligibility Criteria
You may qualify if:
- Post cataract surgery or clear lens
- Best-corrected visual acuity less than 0.1logMAR
You may not qualify if:
- Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
- Diagnosed with ocular diseases that affect observation of visual function;
- History of epileptic seizures;
- Long term use of psychotropic drugs；
- Metal implants in the body.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Eye and Ear, Nose Throat Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiangjia Zhu
Eye and ENT Hospital of Fudan University
- PRINCIPAL INVESTIGATOR
Yating Tang
Eye and ENT Hospital of Fudan University
- PRINCIPAL INVESTIGATOR
Yinglei Zhang
Eye and ENT Hospital of Fudan University
- PRINCIPAL INVESTIGATOR
Jiaqi Meng
Eye and ENT Hospital of Fudan University
- PRINCIPAL INVESTIGATOR
Xin Liu
Eye and ENT Hospital of Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 21, 2024
First Posted
September 25, 2024
Study Start
October 1, 2024
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2027
Last Updated
September 25, 2024
Record last verified: 2024-09