Electrical Stimulation, Glaucoma, Home Treatment
Conditions
Brief 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.
Interventions
PROCEDURETransorbital 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
Sponsors
University of Magdeburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual field size | 3 months | Static perimetry and high resolution perimetry will be used to measure the visual field sizes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EEG connectivities in the visual system | 3 months | EEG recordings will be done using 128 channels, power spectra will be determined |
| Level of vascular regulation/dysregulation in the eye | 3 months | Dynamic vessel analysis will be used the measure blood flow in the eye |
Countries
Germany
Outcome results
None listed