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

University of Magdeburg

Status: Completed

Conditions: Optic Nerve Diseases; Optic Nerve Injuries; Optic Neuropathies

Treatments: Device: Sham stimulation; Device: tACS

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01280877

EBS-PP-2010-08-10-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

90 participants in 2 patient groups

Verum stimulation

Experimental group

Description:

Complete treatment with transorbital alternating current stimulation (tACS)

Treatment:

Device: tACS

Sham stimulation

Sham Comparator group

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.

Treatment:

Device: Sham stimulation