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Completed

NCT Number: NCT02703870

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.

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Key information

Conditions

Hemianopia Blindness Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Eye Diseases Hemianopsia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Stroke Vascular Diseases Vision Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Neurologisches Therapiezentrum Gmundnerberg, Altmünster, Austria

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About this study

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, ...)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

verum tDCS

Device

real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes

Sham tDCS

Device

sham transcranial direct current stimulation, 10 sessions, for 20 minutes

VRT

Behavioral

Vision restoration training, 10 sessions, 20 minutes

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • Neurologisches Therapiezentrum Gmundnerberg

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 9, 2016
Registry last updated
Mar 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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