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Brain Stimulation and Aphasia Treatment (tDCS)

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ClinicalTrials.gov Identifier: NCT01686373
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Medical University of South Carolina
Information provided by (Responsible Party):
Julius Fridriksson, University of South Carolina

Brief Summary:
The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.

Condition or disease Intervention/treatment Phase
Aphasia Device: Activa Dose II Real tDCS Device: Activa Dose II Sham tDCS Phase 2

Detailed Description:
Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes
Study Start Date : April 2012
Actual Primary Completion Date : May 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Experimental: Activa Dose II Real tDCS
Actual delivery of electrical stimulation
Device: Activa Dose II Real tDCS
20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)

Placebo Comparator: Activa Dose II Sham tDCS
Sham delivery of electrical stimulation
Device: Activa Dose II Sham tDCS
20 minutes of sham stimulation per treatment day (15 total sessions)




Primary Outcome Measures :
  1. The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items). [ Time Frame: Immediately post-treatment ]
    The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.



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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be willing and able to give informed consent.
  2. Patients must be willing and able to comply with study requirements.
  3. Patients must be between 25- and 80-years of age.
  4. Patients must be native English speakers.
  5. Patients must be pre-morbidly right-handed.
  6. Patients must have sustained a one-time ischemic stroke in the left-hemisphere.
  7. Patients must be greater than 6-months post-stroke.
  8. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
  9. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).
  10. Patients must achieve at least 65% accuracy on naming task during screening -

Exclusion Criteria:

  1. History of brain surgery
  2. Seizures during the previous 12 months
  3. Sensitive scalp (per patient report)
  4. Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.
  5. Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or 3.

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): NCT01686373


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
University of South Carolina (USC)
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
National Institute on Deafness and Other Communication Disorders (NIDCD)
Medical University of South Carolina
Investigators
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Principal Investigator: Julius Fridriksson, PhD Director
  Study Documents (Full-Text)

Documents provided by Julius Fridriksson, University of South Carolina:
Statistical Analysis Plan  [PDF] August 29, 2012
Study Protocol  [PDF] December 20, 2018


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Julius Fridriksson, Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT01686373     History of Changes
Other Study ID Numbers: 11560FA12
U01DC011739 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2012    Key Record Dates
Results First Posted: August 20, 2019
Last Update Posted: August 20, 2019
Last Verified: July 2019

Keywords provided by Julius Fridriksson, University of South Carolina:
Aphasia
Brain
Stimulation
Communication
Stoke
Post
Phase II Clinical Trial
Treatment
tDCS
Fridriksson

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