Experimental and Clinical Studies of Retinal Stimulation
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|ClinicalTrials.gov Identifier: NCT03635645|
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : August 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Retinitis Pigmentosa||Device: New visual processing unit (VPU) with asymmetric waveforms Device: New VPU with bipolar stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Experimental and Clinical Studies of Retinal Stimulation|
|Actual Study Start Date :||October 30, 2017|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Retinal stimulation
Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus.
Device: New visual processing unit (VPU) with asymmetric waveforms
A VPU will apply asymmetric and symmetric stimulation pulses.
Device: New VPU with bipolar stimulation
A VPU will apply bipolar stimulus pulses.
- Percent change in stimulus thresholds [ Time Frame: Baseline, 8 hours ]Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).
- Change in shape perception [ Time Frame: Baseline, 8 hours ]As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03635645
|Contact: James Weilandemail@example.com|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48105|
|Contact: James Weiland 661-713-4603 firstname.lastname@example.org|
|Principal Investigator:||James Weiland||University of Michigan|