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Completed

NCT Number: NCT03510182

Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS with intensive language therapy as a way of enhancing language outcomes in aphasia

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Key information

Conditions

Aphasia Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Center for Language and Literacy

Ann Arbor, Michigan, 48194, United States

About this study

Intensive therapy for aphasia has been demonstrated to improve language functioning after stroke or other neurological injury. However, recovery is generally not complete and new therapies are needed to improve outcomes. Transcranial direct current stimulation (tDCS) has been shown to improve outcomes with motor therapy after stroke. This study will examine the feasibility of using tDCS supplementing clinically determined intensive language therapy as a way of enhancing language outcomes in aphasia. Eligible clients enrolled in the University of Michigan Aphasia Program (UMAP) will be invited to participate in the study. Clients will receive 20 minutes of tDCS every day along with their usual treatment protocol. Pre and post testing will be completed to assess for improvement in language functioning. This is a feasibility and proof of concept study to determine if a randomized control trial should be pursued

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of aphasia
  • Enrolled in intensive therapy program at the University of Michigan Aphasia Program.
  • Ability to understand and give consent to treatment.

Exclusion criteria

  • No metal implants or surgical devices
  • History of seizures
  • History of significant cognitive or psychiatric disturbance
  • Participant cannot be pregnant at the time of study

Treatment and study plan

Transcranial Direct Current Stimulation

Device

Primary outcomes

  1. Change in Controlled Oral Word Fluency

    Time frame: baseline and 4 weeks

    This test assesses the number of words that can be generated in one minute that begin with certain letters. The total number of words generated for three letters is derived. Higher scores represent better performance. Changes in word fluency were calculated as follows: number of words generated post tDCS minus number of words generated pre tDCS

  2. Change in Boston Naming Score

    Time frame: baseline and 4 weeks

    This test assesses confrontational naming ability to 60 line drawings. Scores range from 0-60 with higher scores representing better performance. Outcome was derived as followed : Picture naming score post tDCS minus picture naming score pre tDCS

Secondary outcomes

  1. Change in Western Aphasia Quotient Score

    Time frame: baseline and 4 weeks

    severity of aphasia is measured by the Western Aphasia Battery Revised. The Aphasia Quotient (AQ) score ranges from 0-100, with 100 being a perfect score. Change in the AQ was derived as follows : AQ post tDCS minus AQ pre tDCS

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 27, 2018
Registry last updated
Sep 20, 2021

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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