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

Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study

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.

Study Overview

• Status: Unknown
• Conditions: Glaucoma; Electrical Stimulation; Home Treatment
• Intervention / Treatment: Procedure: Transorbital electrical stimulation

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Magdeburg, Germany, 39120
    • Institute of Medical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: rtACS; repetitive transorbital ACS	Procedure: Transorbital 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 is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Magdeburg

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2019
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Optic Nerve Diseases; Cranial Nerve Diseases; Cranial Nerve Injuries; Optic Nerve Injuries
• Other Study ID Numbers: StimulationMagd

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data will be available without restriction
• IPD Sharing Time Frame: After publication
• IPD Sharing Access Criteria: Contact to the Principal investigator
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No