NCT04010994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

August 5, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

October 3, 2019

Status Verified

October 1, 2019

Enrollment Period

12 months

First QC Date

July 3, 2019

Last Update Submit

October 2, 2019

Conditions

GlaucomaElectrical StimulationHome Treatment

Outcome Measures

Primary Outcomes (1)

  • Visual field size

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

    3 months

Secondary Outcomes (2)

  • EEG connectivities in the visual system

    3 months

  • Level of vascular regulation/dysregulation in the eye

    3 months

Study Arms (1)

rtACS

OTHER

repetitive transorbital ACS

Procedure: Transorbital electrical stimulation

Interventions

Transorbital electrical stimulationPROCEDURE

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

rtACS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Psychology

Magdeburg, 39120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 27355577BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Institute, Professor

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 8, 2019

Study Start

August 5, 2019

Primary Completion

July 30, 2020

Study Completion

December 31, 2020

Last Updated

October 3, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will share

Data will be available without restriction

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After publication
Access Criteria
Contact to the Principal investigator

Locations

DE(1)