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Trial of Alternating Current Stimulation in Optic Neuropathy (SCT_optnerve)

This study has been completed.
Sponsor:
Collaborator:
EBS Technologies GmbH, Germany
Information provided by:
University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01270126
First received: January 3, 2011
Last updated: January 4, 2011
Last verified: December 2010
History of Changes
  Purpose

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 within the defective visual field sectors of the visual field (primary outcome measure).


Condition Intervention Phase
Optic Nerve Diseases
Optic Nerve Injuries
Optic Neuropathies
 Device: Repetitive transorbital alternating current stimulation
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Patients With Optic Neuropathy Using Transorbital Alternating Current Stimulation - a Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • Detection accuracy (DA) change in percent over baseline within defective visual field sectors [ Time Frame: Nov 2006 - Dec 2010 ] [ Designated as safety issue: No ]
    Central visual 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). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.


Secondary Outcome Measures:
  • Other visual and EEG parameters [ Time Frame: Nov 2006 - Dec 2010 ] [ Designated as safety issue: No ]
    Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.


Enrollment: 22
Study Start Date: November 2006
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rtACS (Verum condition)
Repetitive transorbital alternating current stimulation (rtACS)
 Device: Repetitive transorbital alternating current stimulation
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 1000µA. 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.
Other Name: EBS Alpha Synch
No Intervention: Sham stimulation (placebo condition)
A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)

Detailed Description:

In a prospective, double-blind, randomized, placebo-controlled clinical trial 22 patients with optic nerve damage were randomly assigned to a rtACS- (n=12) or placebo-group (n=10). Visual field measures, visual acuity and EEG-recordings were collected before and after a daily 20-40min treatment for 10-days and at a 2-months-follow-up. Primary outcome measure was detection accuracy (DA) in defective visual field sectors of computer-based high resolution perimetry (HRP). Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • patients with optic nerve lesion
  • stable visual field defect with residual vision
  • lesion age at least 6 months

Exclusion Criteria

  • heart pacemakers and any metal artefacts in head and truncus
  • epileptic seizure within the last 3 years
  • photosensitive epilepsy as determined by EEG
  • mental diseases (schizophrenia etc.)
  • unstable diabetes, diabetes causing diabetic retinopathy
  • macular degeneration, maculopathy with decimal visual acuity below 0.4
  • high blood pressure
  • instable or high level of intraocular pressure (i.e. >27 mmHg)
  • presence of an un-operated tumor anywhere in the body
  • total blindness
  • primary or secondary glaucoma
  • pathological nystagmus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270126

Locations
Germany
Institute of Medical Psychology
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
EBS Technologies GmbH, Germany
Investigators
Principal Investigator: Bernhard A Sabel, PhD University of Magdeburg
  More Information

Additional Information:
Study protocol as submitted (ethical proposal) - link "clinical trials"  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bernhard A. Sabel, University of Magdeburg
ClinicalTrials.gov Identifier: NCT01270126     History of Changes
Other Study ID Numbers: EBS_optnerve_SCT
Study First Received: January 3, 2011
Last Updated: January 4, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Magdeburg:
optic neuropathy
alternating current stimulation
vision recovery
restoration
plasticity

Additional relevant MeSH terms:
Nervous System Diseases
Optic Nerve Diseases
Optic Nerve Injuries
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Cranial Nerve Diseases
Eye Diseases
 Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on June 18, 2013