NCT01280877

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2010

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

January 19, 2011

Last Update Submit

January 27, 2017

Conditions

Optic Nerve DiseasesOptic Nerve InjuriesOptic Neuropathies

Keywords

optic neuropathyvisual fieldelectric stimulationalternating currentperimetry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • DA change in percent over baseline regarding the damage region of the tested visual field (computer-based high-resolution perimetry)

    Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

  • EEG parameters

    Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

  • Reaction time change in ms

    Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

  • Visual acuity (VA)

    Baseline - 8 weeks after stimulation; First follow-up 2 days after treatment course; Second follow-up 8 weeks after treatment course

  • 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

Study Arms (2)

Verum stimulation

EXPERIMENTAL

Complete treatment with transorbital alternating current stimulation (tACS)

Device: tACS

Sham stimulation

SHAM COMPARATOR

Same electrode montage set-up is used during tACS- and placebo-stimulation. Sham stimulation condition consists of minimal treatment with low intensity/few impulses tACS.

Device: Sham stimulation

Interventions

tACSDEVICE

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.

Verum stimulation
Sham stimulationDEVICE

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.

Sham stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinische Neurophysiologie & Abteilung Augenheilkunde, Universitätsmedizin Göttingen

Göttingen, 37075, Germany

Location

Augenklinik Kassel am Klinikum Kassel GmbH

Kassel, 34125, Germany

Location

Inst. f. Medizinische Psychologie, Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

Location

Related 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. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016.

    PMID: 27355577RESULT

MeSH Terms

Conditions

Optic Nerve DiseasesOptic Nerve Injuries

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye DiseasesCranial Nerve InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Bernhard A Sabel, Prof. Dr.

    Direktor, Institut für Medizinische Psychologie, Leipziger Str. 44, D-39120 Magdeburg, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle PI

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

December 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

DE(4)