Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemianopia
• Intervention / Treatment: Device: verum tDCS; Behavioral: VRT; Device: sham tDCS

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, ...)

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Austria
  • Altmuenster, Austria, 4813
    • Neurologisches Therapiezentrum Gmundnerberg
• Germany
  • Magdeburg, Germany, 39120
    • Inst. f. Medical Psychology, Univ. of Magdeburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Verum tDCS; Verum group receiving complete treatment of tDCS	Device: verum tDCS; real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes; Behavioral: VRT; Vision restoration training, 10 sessions, 20 minutes
Sham Comparator: sham tDCS; Sham group receiving sham tDCS	Behavioral: VRT; Vision restoration training, 10 sessions, 20 minutes; Device: sham tDCS; sham transcranial direct current stimulation, 10 sessions, for 20 minutes
Active Comparator: real VRT; Real Vision Restoration Training	Device: verum tDCS; real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes; Device: sham tDCS; sham transcranial direct current stimulation, 10 sessions, for 20 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up	14-20 days post treatment, 3 months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up	power spectra (Volts-squared per Hz (V^2/Hz)	14-20 days post treatment, 3 months follow up
Change in VEP latencies (ms) from baseline to post-intervention and follow up	VEP latencies (ms)	14-20 days post treatment, 3 months follow up
Change in VEP amplitudes (µV) from baseline to post-intervention and follow up	VEP amplitudes (µV)	14-20 days post treatment, 3 months follow up
Change in network coherence from baseline to post-intervention and follow up	network coherence correlations	14-20 days post treatment, 3 months follow up
Number of participants with treatment-related adverse events assessed by a questionnaire	questionnaire recording adverse effects	up to 4 months

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Collaborators: Neurologisches Therapiezentrum Gmundnerberg
• Investigators: Study Director: Bernhard A Sabel, Prof. Dr., Institute of Medical Psychology

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Estimate): March 9, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness; Stroke; Hemianopsia
• Other Study ID Numbers: CES_NTG_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No