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Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

Primary Purpose

Visual Impairment

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

rtACS (verum condition)

placebo stimulation

About this trial

This is an interventional treatment trial for Visual Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

residual vision
patients with optic nerv lesion
lesion age at least 6 months
stable visual field defect

Exclusion Criteria:

electric or electronic implants such as pace maker
any metal artefacts in head and truncus
epilepsia
photosensitive epilepsy as determines by EEG
autoimmune illnesses in acute stage
mental diseases such e.g. schizophrenia etc.
diabetes causing diabetic retinopathy
addiction
high blood pressure
unstable or high level intraocular pressure (i.e. > 27 mmHg)
retinitis pigmentosa
pathological nystagmus
presence of an un-operated tumor or tumor recidive

Sites / Locations

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
Institut für Medizinische Psychologie, Leipziger Str. 44

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rtACS (Verum condition)

Placebo stimulation

Arm Description

Repetitive transorbital alternating current stimulation (rtACS)

no intervention (Sham stimulation)

Outcomes

Primary Outcome Measures

Detection accuracy (DA) change in percent over baseline within defective visual field sectors

Central visus fields were assessed with computer based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind).

Secondary Outcome Measures

Visual Parameters 1

DA in static and kinetic perimetry

Visual Parameters 2

reaction time (RT) in HRP

Visual Parameters 3

visual acuity (VA)

Visual Parameters 4

contrast vision

EEG parameters

EEG power spectra

Full Information

NCT ID

NCT01282827

First Posted

January 21, 2011

Last Updated

January 13, 2021

Sponsor

University of Magdeburg

Collaborators

EBS Technologies GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01282827

Brief Title

Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

Official Title

Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Magdeburg

Collaborators

EBS Technologies GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Non-invasive brain stimulation can increase cortical excitability in the visual system, but it is not known if this is of clinical value. The investigators now assessed if repetitive, transcranial alternating current stimulation (rtACS) can improve visual field size in patients with optic nerve damage. The investigators hypothesized that rtACS would improve visual functions with the defective visual field sectors of the visual field (primary outcome measure).

Detailed Description

exploratory, randomized, controlled study

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visual Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rtACS (Verum condition)

Arm Type

Experimental

Arm Description

Repetitive transorbital alternating current stimulation (rtACS)

Arm Title

Placebo stimulation

Arm Type

Placebo Comparator

Arm Description

no intervention (Sham stimulation)

Intervention Type

Device

Intervention Name(s)

rtACS (verum condition)

Other Intervention Name(s)

Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF, SLG device marking: "5016-07-P/001", Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"

Intervention Description

Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000 microA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.

Intervention Type

Device

Intervention Name(s)

placebo stimulation

Other Intervention Name(s)

Intervention Description

a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).

Primary Outcome Measure Information:

Title

Detection accuracy (DA) change in percent over baseline within defective visual field sectors

Description

Time Frame

between baseline and 60 days after stimulation

Secondary Outcome Measure Information:

Title

Visual Parameters 1

Description

DA in static and kinetic perimetry

Time Frame