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

Optic Nerve Diseases Clinical Trial

Official title:

Multicenter Study of Paraorbital-Occipital Alternating Current Stimulation Therapy in Patients With Optic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280877
• Other study ID #: EBS-PP-2010-08-10-001
• Status: Completed
• Phase: N/A
• First received: January 19, 2011
• Last updated: January 27, 2017
• Start date: December 2010
• Est. completion date: February 2012

Study information

• Verified date: January 2017
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nervous System Diseases
• Optic Nerve Diseases
• Optic Nerve Injuries
• Optic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	EBS Technologies GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection accuracy (DA) change in percent over baseline within defective visual field	Central visual fields assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field are characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors is defined as the primary outcome criterion.	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Secondary	DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)	This parameter includes also intact sectors that are tested with HRP. It is hypothesized that improvements of the primary outcome criterion will outweigh the relative change in intact sectors as measured with HRP.	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Secondary	EEG parameters	EEG power spectra	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Secondary	Reaction time change in ms	Reaction time (RT) in HRP	Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Secondary	Visual acuity (VA)		Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course
Secondary	DA in static and kinetic conventional perimetry		Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course