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Completed

NCT Number: NCT02935413

Combined tDCS and Vision Restoration Training in Subacute Stroke Rehabilitation: A Pilot 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.

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.

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

tDCS

Device

Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes

standard rehabilitation

Behavioral

Standard rehabilitation procedures involving PC-based training of saccades and visual exploration

Primary outcomes

  1. Change of mean sensitivity (in dB) detection threshold from baseline to post-intervention

    Time frame: 14-20 days post treatment,

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • Neurologisches Therapiezentrum Gmundnerberg

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 17, 2016
Registry last updated
Oct 17, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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