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

Primary Purpose

Hemianopia, Stroke

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
verum tDCS
sham tDCS
VRT
Sponsored by
University of Magdeburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemianopia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurologisches Therapiezentrum Gmundnerberg
  • Inst. f. Medical Psychology, Univ. of Magdeburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Verum tDCS

sham tDCS

real VRT

Arm Description

Verum group receiving complete treatment of tDCS

Sham group receiving sham tDCS

Real Vision Restoration Training

Outcomes

Primary Outcome Measures

Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up

Secondary Outcome Measures

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)
Change in VEP latencies (ms) from baseline to post-intervention and follow up
VEP latencies (ms)
Change in VEP amplitudes (µV) from baseline to post-intervention and follow up
VEP amplitudes (µV)
Change in network coherence from baseline to post-intervention and follow up
network coherence correlations
Number of participants with treatment-related adverse events assessed by a questionnaire
questionnaire recording adverse effects

Full Information

First Posted
September 18, 2015
Last Updated
March 3, 2016
Sponsor
University of Magdeburg
Collaborators
Neurologisches Therapiezentrum Gmundnerberg
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1. Study Identification

Unique Protocol Identification Number
NCT02703870
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Magdeburg
Collaborators
Neurologisches Therapiezentrum Gmundnerberg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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, ...)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemianopia, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum tDCS
Arm Type
Active Comparator
Arm Description
Verum group receiving complete treatment of tDCS
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham group receiving sham tDCS
Arm Title
real VRT
Arm Type
Active Comparator
Arm Description
Real Vision Restoration Training
Intervention Type
Device
Intervention Name(s)
verum tDCS
Intervention Description
real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes
Intervention Type
Device
Intervention Name(s)
sham tDCS
Intervention Description
sham transcranial direct current stimulation, 10 sessions, for 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
VRT
Intervention Description
Vision restoration training, 10 sessions, 20 minutes
Primary Outcome Measure Information:
Title
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention and follow up
Time Frame
14-20 days post treatment, 3 months follow up
Secondary Outcome Measure Information:
Title
Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up
Description
power spectra (Volts-squared per Hz (V^2/Hz)
Time Frame
14-20 days post treatment, 3 months follow up
Title
Change in VEP latencies (ms) from baseline to post-intervention and follow up
Description
VEP latencies (ms)
Time Frame
14-20 days post treatment, 3 months follow up
Title
Change in VEP amplitudes (µV) from baseline to post-intervention and follow up
Description
VEP amplitudes (µV)
Time Frame
14-20 days post treatment, 3 months follow up
Title
Change in network coherence from baseline to post-intervention and follow up
Description
network coherence correlations
Time Frame
14-20 days post treatment, 3 months follow up
Title
Number of participants with treatment-related adverse events assessed by a questionnaire
Description
questionnaire recording adverse effects
Time Frame
up to 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard A Sabel, Prof. Dr.
Organizational Affiliation
Institute of Medical Psychology
Official's Role
Study Director
Facility Information:
Facility Name
Neurologisches Therapiezentrum Gmundnerberg
City
Altmuenster
ZIP/Postal Code
4813
Country
Austria
Facility Name
Inst. f. Medical Psychology, Univ. of Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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

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