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

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ClinicalTrials.gov Identifier: NCT03510182
Recruitment Status : Recruiting
First Posted : April 27, 2018
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Carol Persad, University of Michigan

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Aphasia Device: transcranial direct current stimulation Not Applicable

Detailed Description:
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. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All eligible participants with aphasia will receive the tDCS
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) and Intensive Therapy in Aphasia
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: transcranial Direct Current Stimulation
tDCS will be given to all qualified patients with aphasia.
Device: transcranial direct current stimulation



Primary Outcome Measures :
  1. Word fluency [ Time Frame: baseline and 4 weeks ]
    Changes in word fluency

  2. Naming [ Time Frame: baseline and 4 weeks ]
    Change in ability to name picture


Secondary Outcome Measures :
  1. Aphasia severity [ Time Frame: baseline and 4 weeks ]
    severity of aphasia as measured by the Western Aphasia Battery Revised



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03510182


Contacts
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Contact: Carol Persad, PhD 7347648440 cpersad@umich.edu

Locations
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United States, Michigan
University Center for Language and Literacy Recruiting
Ann Arbor, Michigan, United States, 48194
Contact: Carol Persad, PhD    734-764-8440    cpersad@umich.edu   
Sponsors and Collaborators
University of Michigan

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Responsible Party: Carol Persad, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03510182     History of Changes
Other Study ID Numbers: HUM00108213
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms