Non-invasive Current Stimulation for Restoration of Vision

Stroke Clinical Trial

Official title:

Non-invasive Current Stimulation for Restoration of Vision (REVIS) After Unilateral Occipital Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008589
• Other study ID #: REVIS
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 1, 2014
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2020
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 5, 2020
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Electrical Stimulation
• Stroke

Intervention

Device:
• repetitive transorbital AC Stimulation
Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day
• combination of transcranial direct current stimulaton and rtACS
Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS

Locations

Country	Name	City	State
Germany	Institute of Medical Psychology	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	ERA-NET

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of the visual field	Mean threshold in standard static perimetry and and detection accuracy in HRP	2 weeks
Secondary	Resting EEG power spectra	EEG measurement using 128 channel	2 weeks