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

University of Magdeburg

Status: Completed

Conditions: Visual Impairment

Treatments: Device: rtACS (verum condition); Device: placebo stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01282827

EBS-optnerv-BCT

Details and patient eligibility

About

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).

Full description

exploratory, randomized, controlled study

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

rtACS (Verum condition)

Experimental group

Description:

Repetitive transorbital alternating current stimulation (rtACS)

Treatment:

Device: rtACS (verum condition)

Placebo stimulation

Placebo Comparator group

Description:

no intervention (Sham stimulation)

Treatment:

Device: placebo stimulation