MedTrace Logo

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

NCT01418820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-07-05

No results posted yet for this study

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

  • Complete Hemianopia
  • Incomplete Hemianopia
  • Scotoma
  • Quadrantanopia
  • Stroke
  • Hemorrhage
  • Brain Trauma

Interventions

DEVICE

Verum stimulation

10 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.

DEVICE

Placebo stimulation

10 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.

Sponsors & Collaborators

  • EBS Technologies GmbH

    collaborator INDUSTRY

  • University of Magdeburg

    lead OTHER

Principal Investigators

  • Bernhard A Sabel, Ph.D. · Univ. of Magdeburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418820 on ClinicalTrials.gov