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

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

December 31, 2010

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Optic Nerve DiseasesOptic Nerve InjuriesOptic Neuropathies
Interventions
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.

DEVICE

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.

Trial Locations (4)

10117

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin, Berlin

34125

Augenklinik Kassel am Klinikum Kassel GmbH, Kassel

37075

Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen, Göttingen

39120

Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg, Magdeburg

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

EBS Technologies GmbH

INDUSTRY

lead

University of Magdeburg

OTHER

NCT01280877 - Paraorbital-Occipital Alternating Current Stimulation Therapy for Optic Neuropathy (MCT_optnerve) | Biotech Hunter | Biotech Hunter