NCT04008589

Brief Summary

The aim of the study is to evaluate effects of current stimulation of the brain on vision parameters, vision-related quality of life, and physiological parameters to uncover mechanisms of vision restoration. These include EEG-spectra and coherence measures, and visual evoked potentials. The design of stimulation protocols involves an appropriate sham-stimulation condition and sufficient follow-up periods to test whether the effects are stable. This is the first application of non-invasive current stimulation for vision rehabilitation in stroke-related visual field deficits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 stroke

Timeline
Completed

Started Jan 2014

Longer than P75 for phase_1 stroke

Geographic Reach
1 country

1 active site

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

January 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

July 3, 2019

Last Update Submit

November 6, 2020

Conditions

StrokeElectrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • Size of the visual field

    Mean threshold in standard static perimetry and and detection accuracy in HRP

    2 weeks

Secondary Outcomes (1)

  • Resting EEG power spectra

    2 weeks

Study Arms (3)

rtACS

EXPERIMENTAL

repetitive transorbital ACS

Device: repetitive transorbital AC StimulationDevice: combination of transcranial direct current stimulaton and rtACS

tDCS/rtACS

EXPERIMENTAL

Sequential tDCS - tACS

Device: repetitive transorbital AC StimulationDevice: combination of transcranial direct current stimulaton and rtACS

Sham stimulation

SHAM COMPARATOR
Device: repetitive transorbital AC StimulationDevice: combination of transcranial direct current stimulaton and rtACS

Interventions

repetitive transorbital AC StimulationDEVICE

Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day

Sham stimulationrtACStDCS/rtACS
combination of transcranial direct current stimulaton and rtACSDEVICE

Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Sham stimulationrtACStDCS/rtACS

Eligibility Criteria

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

You may qualify if:

  • HH due to ischemic or hemorrhagic stroke
  • age between 18 and 75 years
  • lesion age at least 6 months
  • stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
  • presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
  • best corrected visual acuity at least 0.4 (20/50 Snellen) or better

You may not qualify if:

  • known active malignancy
  • eye or central nervous system diseases that interfere with the study (including poorly controlled glaucoma)
  • electric or electronic implants (e.g. heart pacemaker)
  • metal artifacts in the eyes or head (with the exception of dental prosthesis or shunts)
  • expected low compliance (e.g. in case of known psychiatric disease, known drug abuse, and dementing syndromes)
  • epileptic seizure within the last 10 years
  • use of antiepileptic or sedative drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Medical Psychology

Magdeburg, 39120, Germany

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized, controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 3, 2019

First Posted

July 5, 2019

Study Start

January 1, 2014

Primary Completion

March 31, 2016

Study Completion

November 5, 2020

Last Updated

November 10, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Research data will be avalaible without restriction

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
After the publication of the data
Access Criteria
Contact to the PI

Locations

DE(1)