NCT04010994

Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Magdeburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past. Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.

Conditions

• Glaucoma
• Electrical Stimulation
• Home Treatment

Interventions

Type	Name	Description
PROCEDURE	Transorbital electrical stimulation	Transorbital ACS using 8-12 Hz with 0,5-1,5 mA Intensity, during the first two weeks 1/day, after 2/week for 10 weeks, as a home treatment

Timeline

• Start date: 2019-08-05
• Primary completion: 2020-07-30
• Completion: 2020-12-31
• First posted: 2019-07-08
• Last updated: 2019-10-03

Locations

1 site across 1 country: Germany