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

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ClinicalTrials.gov Identifier: NCT04010994
Recruitment Status : Enrolling by invitation
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Bernhard A. Sabel, 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.


Condition or disease Intervention/treatment Phase
Glaucoma Electrical Stimulation Home Treatment Procedure: Transorbital electrical stimulation Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
Estimated Study Start Date : August 5, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Visual field size [ Time Frame: 3 months ]
    Static perimetry and high resolution perimetry will be used to measure the visual field sizes


Secondary Outcome Measures :
  1. EEG connectivities in the visual system [ Time Frame: 3 months ]
    EEG recordings will be done using 128 channels, power spectra will be determined

  2. Level of vascular regulation/dysregulation in the eye [ Time Frame: 3 months ]
    Dynamic vessel analysis will be used the measure blood flow in the eye



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010994


Locations
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Germany
Institute of Medical Psychology
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg

Publications:
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Responsible Party: Bernhard A. Sabel, Head of Institute, Professor, University of Magdeburg
ClinicalTrials.gov Identifier: NCT04010994     History of Changes
Other Study ID Numbers: StimulationMagd
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available without restriction
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: After publication
Access Criteria: Contact to the Principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Optic Nerve Injuries
Eye Diseases
Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries