Multicenter Study of Transcranial Magnetic Stimulation on Vision Restoration
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-70
SponsorShanghai High Myopia Study Group
About this 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:
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
between 45 and 70 years old
bilateral severe MMD (META-PM grades ≥ 3)
no prior TMS history or contraindications to TMS
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial magnetic stimulation targeting occipital visual cortex
Procedure/SurgeryTranscranial magnetic stimulation targeting occipital visual cortex
Sham stimulation
Procedure/Surgeryidentical procedure using a sham coil without effective magnetic field output
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: TMSExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
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 monthsSecondary 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 monthsOther 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 months2
Contrast sensitivity function change
Change in contrast sensitivity function from baseline to 3 months post-treatment
Time frame
baseline and 3 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: