Clinical trial NCT01280877: 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
Overall status: COMPLETED
Phase: NA
Conditions: Optic Nerve Diseases
Optic Nerve Injuries
Optic Neuropathies
Keywords: optic neuropathy
visual field
electric stimulation
alternating current
perimetry
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: EBS Technologies GmbH
First posted: 2011-01-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Detection accuracy (DA) change in percent over baseline within defective visual field
timeFrame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Secondary outcomes:
measure: DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)
timeFrame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
measure: EEG parameters
timeFrame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
measure: Reaction time change in ms
timeFrame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
measure: Visual acuity (VA)
timeFrame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
measure: DA in static and kinetic conventional perimetry
timeFrame: Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin
city: Göttingen
country: Germany
facility: Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen
city: Kassel
country: Germany
facility: Augenklinik Kassel am Klinikum Kassel GmbH
city: Magdeburg
country: Germany
facility: Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg
Study officials:
affiliation: Direktor, Institut für Medizinische Psychologie, Leipziger Str. 44, D-39120 Magdeburg, Germany
name: Bernhard A Sabel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.