Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
Primary Purpose
Hemianopia, Stroke
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
tDCS
Standard rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Hemianopia
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
Sites / Locations
- Neurologisches Therapiezentrum Gmundnerberg
- Inst. f. Medical Psychology, Univ. of Magdeburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
tDCS
Standard rehabilitation
Arm Description
group receiving complete treatment of transcranial direct current stimulation
Standard rehabilitation procedures
Outcomes
Primary Outcome Measures
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT02935413
First Posted
October 13, 2016
Last Updated
October 13, 2016
Sponsor
University of Magdeburg
Collaborators
Neurologisches Therapiezentrum Gmundnerberg
1. Study Identification
Unique Protocol Identification Number
NCT02935413
Brief Title
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
Official Title
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (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.
Seven post-acute stroke homonymous hemianopia patients were assigned to 10 sessions of combined tDCS (2mA, 10 daily sessions of 15-20 min) and VRT. The primary outcome criterion was the pre-post change in perimetric detection thresholds in percent. The results were compared to 7 age and stroke lesion matched controls of our patient data pool who received standard rehabilitation.
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS
Arm Type
Active Comparator
Arm Description
group receiving complete treatment of transcranial direct current stimulation
Arm Title
Standard rehabilitation
Arm Type
Active Comparator
Arm Description
Standard rehabilitation procedures
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
Standard rehabilitation
Intervention Description
Standard rehabilitation procedures involving PC-based training of saccades and visual exploration
Primary Outcome Measure Information:
Title
Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention
Time Frame
14-20 days post treatment,
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
Raimund Alber, MS
Organizational Affiliation
Neurologisches Therapiezentrum Gmundnerberg
Official's Role
Principal Investigator
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
Citations:
PubMed Identifier
28082176
Citation
Alber R, Moser H, Gall C, Sabel BA. Combined Transcranial Direct Current Stimulation and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study. PM R. 2017 Aug;9(8):787-794. doi: 10.1016/j.pmrj.2016.12.003. Epub 2017 Jan 8.
Results Reference
derived
Learn more about this trial
Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot Study
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