Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

Study Overview
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Brief Summary
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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 Title
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Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study

Conditions
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Glaucoma, Electrical Stimulation, Home Treatment

Intervention / Treatment
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* Procedure: Transorbital electrical stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: autoimmune diseases in the acute stage neurological and mental diseases diabetic retinopathy addictions hypertension (maximum 160/100 mmHg) retinitis pigmentosa- pathological nystagmus non-distant tumors or recurrent tumors photosensitivity pregnancy electric or electronic implants (e.g. heart pacemaker) metal implants in the eyes or head (with the exception of dental prosthesis or shunts)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: rtACS<br>repetitive transorbital ACS | Procedure: Transorbital electrical stimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual field size | Static perimetry and high resolution perimetry will be used to measure the visual field sizes | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG connectivities in the visual system | EEG recordings will be done using 128 channels, power spectra will be determined | 3 months | 
| Level of vascular regulation/dysregulation in the eye | Dynamic vessel analysis will be used the measure blood flow in the eye | 3 months |