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

Primary Purpose

Glaucoma, Electrical Stimulation, Home Treatment

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Transorbital electrical stimulation
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Institute of Medical Psychology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

rtACS

Arm Description

repetitive transorbital ACS

Outcomes

Primary Outcome Measures

Visual field size
Static perimetry and high resolution perimetry will be used to measure the visual field sizes

Secondary Outcome Measures

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

Full Information

First Posted
July 3, 2019
Last Updated
October 2, 2019
Sponsor
University of Magdeburg
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1. Study Identification

Unique Protocol Identification Number
NCT04010994
Brief Title
Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation
Acronym
HomeStim
Official Title
Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 5, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Electrical Stimulation, Home Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rtACS
Arm Type
Other
Arm Description
repetitive transorbital ACS
Intervention Type
Procedure
Intervention Name(s)
Transorbital electrical stimulation
Intervention Description
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 Measure Information:
Title
Visual field size
Description
Static perimetry and high resolution perimetry will be used to measure the visual field sizes
Time Frame
3 months
Secondary Outcome Measure Information:
Title
EEG connectivities in the visual system
Description
EEG recordings will be done using 128 channels, power spectra will be determined
Time Frame
3 months
Title
Level of vascular regulation/dysregulation in the eye
Description
Dynamic vessel analysis will be used the measure blood flow in the eye
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
Institute of Medical Psychology
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available without restriction
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
Contact to the Principal investigator
Citations:
PubMed Identifier
27355577
Citation
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.
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Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

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