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

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

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).

Study Overview

• Status: Completed
• Conditions: Optic Nerve Diseases; Optic Nerve Injuries; Optic Neuropathies
• Intervention / Treatment: Device: tACS; Device: Sham stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
  • Göttingen, Germany, 37075
    • Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen
  • Kassel, Germany, 34125
    • Augenklinik Kassel am Klinikum Kassel GmbH
  • Magdeburg, Germany, 39120
    • Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verum stimulation; Complete treatment with transorbital alternating current stimulation (tACS)	Device: tACS; 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.
SHAM_COMPARATOR: Sham stimulation; 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.	Device: Sham stimulation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
EEG parameters	EEG power spectra	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Reaction time change in ms	Reaction time (RT) in HRP	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Visual acuity (VA)		Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
DA in static and kinetic conventional perimetry		Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Collaborators: EBS Technologies GmbH
• Investigators: Principal Investigator: Bernhard A Sabel, Prof. Dr., Direktor, Institut für Medizinische Psychologie, Leipziger Str. 44, D-39120 Magdeburg, Germany

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (ACTUAL): February 1, 2012
• Study Completion (ACTUAL): February 1, 2012

Study Registration Dates

• First Submitted: January 19, 2011
• First Submitted That Met QC Criteria: January 19, 2011
• First Posted (ESTIMATE): January 21, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: electric stimulation; perimetry; visual field; optic neuropathy; alternating current
• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Neuromuscular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Cranial Nerve Injuries; Peripheral Nervous System Diseases; Nervous System Diseases; Optic Nerve Diseases; Optic Nerve Injuries
• Other Study ID Numbers: EBS-PP-2010-08-10-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No