Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

Phase 1

• Conditions: Glaucoma; Home Treatment; Electrical Stimulation
• Interventions: Procedure: Transorbital electrical stimulation

• Registration Number: NCT04010994
• Lead Sponsor: University of Magdeburg

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-04
• Study First Posted: 2019-07-08
• Study Start: 2019-08-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-03
• Primary Completion: 2020-07-30
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rtACS	Transorbital electrical stimulation	repetitive transorbital ACS

Primary Outcome Measures

Name	Time	Method
Visual field size	3 months	Static perimetry and high resolution perimetry will be used to measure the visual field sizes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institute of Medical Psychology; 🇩🇪 Magdeburg, Germany