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NCT Number: NCT02540109

Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study

This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as alternate outcome measures, subject selection criteria, and benefits of extended treatment duration. These results will be compared to an existing trial using conventional non-targeted tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while performing computerized anomia treatment. The basis behind this method is that language therapy is mediated by cortical areas that are most effectively activated during the training tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To better understand the long term benefits of the adjunctive treatment, patients will be screened again four weeks and six months after study using the same anomia tests. If HD-tDCS shows promising results in increasing the learning outcomes of anomia treatment, a Phase III trial can be considered.

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Key information

Conditions

Chronic Aphasia Anomia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Georgetown University Medical Center (Peter Turkeltaub, MD, Ph.D.), Washington D.C., District of Columbia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • one-time ischemic stroke in the left hemisphere
  • greater than 6-months post-stroke onset
  • between 25 and 75 years of age
  • aphasia diagnosis (as determined by pre-treatment language-based testing)
  • right-handed (before the stroke)
  • native speaker of English
  • ability to provide informed written or verbal consent

Exclusion criteria

  • clinically reported history of dementia, alcohol abuse, psychiatric disorder, traumatic brain injury, or extensive visual acuity or visual-spatial problems
  • factors contraindicative of tDCS administration (sensitive scalp, previous brain surgery)
  • prior history of epileptic or unprovoked seizures occurring during the previous 12 months.
  • Presence of Metal implants of claustrophobia (not able to undergo MRI)
  • Pregnancy
  • Presence of any other neurological disease than stroke
  • Childhood history of speech, language, hearing, or intellectual impairment

Treatment and study plan

HD-tDCS (Soterix Medical, Active)

Device

Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.

Other names: Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets

HD-tDCS (Soterix Medical, Sham)

Device

Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.

Other names: Soterix Medical High-Definition MxN stimulator, Soterix Medical HDTargets

Primary outcomes

  1. Effect size of HD-tDCS for the adjunctive treatment of anomia in chronic aphasia after stroke

    Time frame: 3 weeks

    The primary outcome measures the ability of subjects to name objects in a standardized naming task. Prior to treatment MRI and fMRI are acquired to inform the individualized current flow models for optimal targeting.

Secondary outcomes

  1. Determine alternate outcome measures

    Time frame: 4 weeks and 6 months follow up

    Determine alternate outcome measures, such as naming performance at 4 weeks and 6 months after treatment and improvements in more general discourse performance. An additional secondary exploratory objective is to perform a screening comparison of HD-tDCS with historical data on conventional non-targeted tDCS using sponge electrodes.

Sponsors and collaborators

Lead sponsor

Soterix Medical

Industry

Collaborators

  • Georgetown University
  • Medstar Health Research Institute
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • The City College of New York
  • University of North Carolina, Chapel Hill
  • University of South Carolina

Registry information

Official study title

Targeted Transcranial Electrotherapy for Stroke Rehabilitation - Exploratory Trial on Aphasia

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 3, 2015
Registry last updated
Dec 5, 2023

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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