Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation (HomeStim)

University of Magdeburg

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Home Treatment; Electrical Stimulation; Glaucoma

Treatments: Procedure: Transorbital electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04010994

StimulationMagd

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

rtACS

Other group

Description:

repetitive transorbital ACS

Treatment:

Procedure: Transorbital electrical stimulation