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Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve)

Primary Purpose

Optic Nerve Diseases, Optic Nerve Injuries, Optic Neuropathies

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

tACS

Sham stimulation

About this trial

This is an interventional treatment trial for Optic Nerve Diseases focused on measuring optic neuropathy, visual field, electric stimulation, alternating current, perimetry

Eligibility Criteria

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

Inclusion Criteria:

patients with optic nerve lesion
stable visual field defect with residual vision
lesion age at least 6 months
age at least 18 years
no completely blindness, residual vision still existent

Exclusion Criteria:

electric or electronic implants, e.g. heart pacemaker
any metal artefacts in head and truncus
epilepsy
auto-immune diseases in acute stage
mental diseases, e.g. schizophrenia etc.
unstable diabetes, diabetes causing diabetic retinopathy
addiction
high blood pressure (max. 160/100 mmHg)
instable or high level of intraocular pressure (i.e. > 27 mmHg)
retinitis pigmentosa
pathological nystagmus
presence of an un-operated tumor anywhere in the body
pregnant or breast-feeding women
photo sensibility
Fundus hypertonicus
acute conjunctivitis

Sites / Locations

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen
Augenklinik Kassel am Klinikum Kassel GmbH
Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Verum stimulation

Sham stimulation

Arm Description

Complete treatment with transorbital alternating current stimulation (tACS)

Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS.

Outcomes

Primary Outcome Measures

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

Central visual fields assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field are characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors is defined as the primary outcome criterion.

Secondary Outcome Measures

DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)

This parameter includes also intact sectors that are tested with HRP. It is hypothesized that improvements of the primary outcome criterion will outweigh the relative change in intact sectors as measured with HRP.

EEG parameters

EEG power spectra

Reaction time change in ms

Reaction time (RT) in HRP

Visual acuity (VA)

DA in static and kinetic conventional perimetry

Full Information

NCT ID

NCT01280877

First Posted

January 19, 2011

Last Updated

January 27, 2017

Sponsor

University of Magdeburg

Collaborators

EBS Technologies GmbH

1. Study Identification

Unique Protocol Identification Number

NCT01280877

Brief Title

Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve)

Official Title

Multicenter Study of Paraorbital-Occipital Alternating Current Stimulation Therapy in Patients With Optic Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Magdeburg

Collaborators

EBS Technologies GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Aim is to validate that non-invasive brain stimulation can increase cortical excitability in the visual system. The investigators assess if transcranial alternating current stimulation (tACS) can improve visual field size in patients with optic nerve damage. Hypothesis: tACS would improve visual functions within the defective visual field (primary outcome measure).

Detailed Description

In addition, the correlation between the brain-derived neurotrophic factor (BDNF) or other plasticity markers are correlated to the improvement of the visual field after stimulation.

6. Conditions and Keywords

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

Optic Nerve Diseases, Optic Nerve Injuries, Optic Neuropathies

Keywords

optic neuropathy, visual field, electric stimulation, alternating current, perimetry

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum stimulation

Arm Type

Experimental

Arm Description

Complete treatment with transorbital alternating current stimulation (tACS)

Arm Title

Sham stimulation

Arm Type

Sham Comparator

Arm Description

Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS.

Intervention Type

Device

Intervention Name(s)

tACS

Intervention Description

Transorbital alternating current stimulation (tACS) is applied with a multi-channel device with paraorbital montage of 4 stimulation electrodes generating weak current pulses in predetermined firing bursts of 8 to 14 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)

Sham stimulation

Intervention Description

tACS is applied with the same device with equal electrodes set-up procedures but only one of four channels actually delivers current. The current intensity of this channel is individually adjusted (preselected on the side of lesioned eye) according with patient able to clearly perceive single phosphenes or any skin irritation phenomena (like weak sense of needles or vibration) whenever a single pulse is applied. The amplitude of pulses is always below 1000 microA. Current pulses are given as 1 pulse per minute during 25-35 min of session time. Session duration is equal for verum and sham patients. The perception of the single pulses leaves sham patients at the impression that they might receive the verum intervention, but total number of pulses is less than 0,5% of verum tACS.

Primary Outcome Measure Information:

Title

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

Description

Time Frame