Clinical trial NCT02703870: Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
Official title: Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hemianopia
Stroke
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: Neurologisches Therapiezentrum Gmundnerberg
First posted: 2016-03-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Study is to determine whether non-invasive transcranial direct current stimulation (tDCS) is effective in increasing rehabilitation effects after stroke in visual Cortex.

Detailed description: Visual field defects after posterior cerebral artery stroke can be improved by vision restoration training (VRT), but when combined with transcranial direct current stimulation (tDCS) which alters brain excitability, vision restoration can be potentiated in the chronic stage. Because it is possible that such therapy may be more effective during the early recovery phase after the stroke and can reach patients during the rehabilitation phase, investigators wished to explore the applicability, efficacy and safety of early intervention with a combined tDCS/VRT treatment.

19 post-acute stroke homonymous hemianopia patients were randomly assigned to either 10 sessions of combined rea-tDCS (2mA, 10 daily sessions of 15-20 min) and VRT, or sham-tDCS and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds. Secondary outcome is neurophysiological changes in EEG measures (VEP, Connectivity, Spectral Power, ...)

Eligibility criteria: Inclusion Criteria:

* Posterior Cerebral Artery Stroke
* Visual Field Defect
* Lesion age 4 weeks up to 6 month max.

Exclusion Criteria:

* Electrical Implants
* Metal artefacts in head
* Epilepsy
* Visual Neglect

Primary outcomes:
measure: Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up
timeFrame: 14-20 days post treatment, 3 months follow up
Secondary outcomes:
measure: Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up
timeFrame: 14-20 days post treatment, 3 months follow up
measure: Change in VEP latencies (ms) from baseline to post-intervention and follow up
timeFrame: 14-20 days post treatment, 3 months follow up
measure: Change in VEP amplitudes (µV) from baseline to post-intervention and follow up
timeFrame: 14-20 days post treatment, 3 months follow up
measure: Change in network coherence from baseline to post-intervention and follow up
timeFrame: 14-20 days post treatment, 3 months follow up
measure: Number of participants with treatment-related adverse events assessed by a questionnaire
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Altmuenster
country: Austria
facility: Neurologisches Therapiezentrum Gmundnerberg
city: Magdeburg
country: Germany
facility: Inst. f. Medical Psychology, Univ. of Magdeburg
Study officials:
affiliation: Institute of Medical Psychology
name: Bernhard A Sabel, Prof. Dr.
role: STUDY_DIRECTOR
References: