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

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ClinicalTrials.gov Identifier: NCT02703870
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Collaborator:
Neurologisches Therapiezentrum Gmundnerberg
Information provided by (Responsible Party):
Bernhard A. Sabel, University of Magdeburg

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.

Condition or disease Intervention/treatment Phase
Hemianopia Stroke Device: verum tDCS Device: sham tDCS Behavioral: VRT Phase 1 Phase 2

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, ...)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined tDCS and Vision Restoration Training in Post-acute Stroke: an Exploratory Efficacy and Safety Study
Study Start Date : March 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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
Device: sham tDCS
sham transcranial direct current stimulation, 10 sessions, for 20 minutes

Behavioral: VRT
Vision restoration training, 10 sessions, 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




Primary Outcome Measures :
  1. 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 Measures :
  1. Change in power spectra (Volts-squared per Hz (V^2/Hz) from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    power spectra (Volts-squared per Hz (V^2/Hz)

  2. Change in VEP latencies (ms) from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    VEP latencies (ms)

  3. Change in VEP amplitudes (µV) from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    VEP amplitudes (µV)

  4. Change in network coherence from baseline to post-intervention and follow up [ Time Frame: 14-20 days post treatment, 3 months follow up ]
    network coherence correlations

  5. Number of participants with treatment-related adverse events assessed by a questionnaire [ Time Frame: up to 4 months ]
    questionnaire recording adverse effects



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703870


Locations
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Austria
Neurologisches Therapiezentrum Gmundnerberg
Altmuenster, Austria, 4813
Germany
Inst. f. Medical Psychology, Univ. of Magdeburg
Magdeburg, Germany, 39120
Sponsors and Collaborators
University of Magdeburg
Neurologisches Therapiezentrum Gmundnerberg
Investigators
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Study Director: Bernhard A Sabel, Prof. Dr. Institute of Medical Psychology

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Responsible Party: Bernhard A. Sabel, Prof. Dr., University of Magdeburg
ClinicalTrials.gov Identifier: NCT02703870     History of Changes
Other Study ID Numbers: CES_NTG_1
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Stroke
Hemianopsia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Blindness
Eye Diseases
Signs and Symptoms