Status unknownNCT04010994HomeStimUpdated Oct 3, 2019

Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

A Phase 1/2 interventional study of Transorbital electrical stimulation in Glaucoma, Electrical Stimulation and Home Treatment, sponsored by University of Magdeburg. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-03.

Sponsored by University of Magdeburg · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Phase 1/2
Study type: Interventional
Enrollment: 50
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Glaucoma
Electrical Stimulation
Home Treatment

In context

Lead sponsor

University of Magdeburg is the lead sponsor of 33 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 50 participants (actual)

Study arms

Other
rtACS
repetitive transorbital ACS
Procedure: Transorbital electrical stimulation

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

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Study locations

1 site

Institute of Medical Psychology
Magdeburg, 39120, Germany

References and documents

Publications

Gall C, Schmidt S, Schittkowski MP, Antal A, Ambrus GG, Paulus W, Dannhauer M, Michalik R, Mante A, Bola M, Lux A, Kropf S, Brandt SA, Sabel BA. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016. PubMed 27355577 ↗

Individual participant data

Plan to share: Yes — Data will be available without restriction

Supporting information: Study protocol, Sap, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 3, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04010994
Lead sponsor: University of Magdeburg
Responsible party: Bernhard A. Sabel (Head of Institute, Professor, University of Magdeburg) — Principal investigator
First posted: Jul 8, 2019
Start date: Aug 5, 2019
Primary completion: Jul 30, 2020 (estimated)
Completion: Dec 31, 2020 (estimated)
Last update: Oct 3, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Optic Nerve Injuries

Other studies from this sponsor

University of Magdeburg

Start the discussion