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

Visual Impairment Clinical Trial

Official title:

Paraorbital-occipital Alternating Electric Current Stimulation in Patients With Optic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01282827
• Other study ID #: EBS-optnerv-BCT
• Status: Completed
• Phase: N/A
• Start date: November 2006
• Est. completion date: March 2010

Study information

• Verified date: January 2021
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

exploratory, randomized, controlled study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Device:
• rtACS (verum condition)
Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 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.
• placebo stimulation
a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).

Locations

Country	Name	City	State
Germany	Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin	Berlin
Germany	Institut für Medizinische Psychologie, Leipziger Str. 44	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	EBS Technologies GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection accuracy (DA) change in percent over baseline within defective visual field sectors	Central visus fields were assessed with computer based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind).	between baseline and 60 days after stimulation
Secondary	Visual Parameters 1	DA in static and kinetic perimetry	baseline to 60 days after stimulation
Secondary	Visual Parameters 2	reaction time (RT) in HRP	baseline to 60 days after stimulation
Secondary	Visual Parameters 3	visual acuity (VA)	baseline to 60 days after stimulation
Secondary	Visual Parameters 4	contrast vision	baseline to 60 days after stimulation
Secondary	EEG parameters	EEG power spectra	baseline to 60 days after stimulation