Clinical Trials Directory

Trials / Completed

CompletedNCT01418820

Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
32 (actual)
Sponsor
University of Magdeburg · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas. It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.

Conditions

Interventions

TypeNameDescription
DEVICEVerum stimulation10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion.
DEVICEPlacebo stimulation10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude.

Timeline

Start date
2011-03-01
Primary completion
2013-12-01
Completion
2013-12-01
First posted
2011-08-17
Last updated
2019-07-05

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01418820. Inclusion in this directory is not an endorsement.