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

NCT ID: NCT01280877

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2012-02-29

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.

Conditions

Optic Nerve Diseases; Optic Nerve Injuries; Optic Neuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum stimulation

Complete treatment with transorbital alternating current stimulation (tACS)

Group Type: EXPERIMENTAL

tACS

Intervention Type: DEVICE

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 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.

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EBS Technologies GmbH

INDUSTRY

Sponsor Role: collaborator

University of Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Bernhard A. Sabel

Principle PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernhard A Sabel, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Direktor, Institut für Medizinische Psychologie, Leipziger Str. 44, D-39120 Magdeburg, Germany

Locations

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin

Berlin, , Germany

Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen

Göttingen, , Germany

Augenklinik Kassel am Klinikum Kassel GmbH

Kassel, , Germany

Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg

Magdeburg, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 27355577 (View on PubMed)

Other Identifiers

EBS-PP-2010-08-10-001

Identifier Type: -

Identifier Source: org_study_id