NCT01282827

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

November 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

January 21, 2011

Last Update Submit

January 13, 2021

Conditions

Visual Impairment

Outcome Measures

Primary Outcomes (1)

  • Detection accuracy (DA) change in percent over baseline within defective visual field sectors

    Central visus 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).

    between baseline and 60 days after stimulation

Secondary Outcomes (5)

  • Visual Parameters 1

    baseline to 60 days after stimulation

  • Visual Parameters 2

    baseline to 60 days after stimulation

  • Visual Parameters 3

    baseline to 60 days after stimulation

  • Visual Parameters 4

    baseline to 60 days after stimulation

  • EEG parameters

    baseline to 60 days after stimulation

Study Arms (2)

rtACS (Verum condition)

EXPERIMENTAL

Repetitive transorbital alternating current stimulation (rtACS)

Device: rtACS (verum condition)

Placebo stimulation

PLACEBO COMPARATOR

no intervention (Sham stimulation)

Device: placebo stimulation

Interventions

rtACS (verum condition)DEVICE

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 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.

Also known as: Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF, SLG device marking: "5016-07-P/001", Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"
rtACS (Verum condition)
placebo stimulationDEVICE

a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).

Also known as: Device for electrical stimulation "Brainstim", Hersteller: "ELSTIM", St. Petersburg, Russland, Device number: "07062006", Classification: Class II, Type BF, SLG device marking: "5016-07-P/001", Modifications of the device have been performed before the SLG test by "Eurotronics Weißenfelser Straße 67, D-04229 Leipzig"
Placebo stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • electric or electronic implants such as pace maker
  • any metal artefacts in head and truncus
  • epilepsia
  • photosensitive epilepsy as determines by EEG
  • autoimmune illnesses in acute stage
  • mental diseases such e.g. schizophrenia etc.
  • diabetes causing diabetic retinopathy
  • addiction
  • high blood pressure
  • unstable or high level intraocular pressure (i.e. \> 27 mmHg)
  • retinitis pigmentosa
  • pathological nystagmus
  • presence of an un-operated tumor or tumor recidive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik für Neurologie, Charité Campus Mitte, Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Institut für Medizinische Psychologie, Leipziger Str. 44

Magdeburg, 39120, Germany

Location

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bernhard A Sabel, Prof. Dr.

    University of Magdeburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Inst Med Psychol

Study Record Dates

First Submitted

January 21, 2011

First Posted

January 25, 2011

Study Start

November 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

January 15, 2021

Record last verified: 2021-01

Locations

DE(2)