Suspended

HomeStimHome-based Electrostimulation for Optic Nerve Damage: Visual Field Enhancement and Factors Affecting Treatment Effectiveness

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What is being tested

Transorbital electrical stimulation

Procedure
Who is being recruted

Eye Diseases

+ Glaucoma

+ Ocular Hypertension

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: August 2019
See protocol details

Summary

Principal SponsorUniversity of Magdeburg
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 5, 2019

Actual date on which the first participant was enrolled.

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.

Official TitleTreatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
NCT04010994
Principal SponsorUniversity of Magdeburg
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesGlaucomaOcular Hypertension

Criteria

4 inclusion criteria required to participate
Patients with glaucoma, disease duration at least 6 months
stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
best corrected visual acuity at least 0.4 (20/50 Snellen) or better
12 exclusion criteria prevent from participating
autoimmune diseases in the acute stage
neurological and mental diseases
diabetic retinopathy
addictions
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

repetitive transorbital ACS

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Institute of Medical Psychology

Magdeburg, GermanyOpen Institute of Medical Psychology in Google Maps
SuspendedOne Study Center