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Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Aphasia

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ClinicalTrials.gov Identifier: NCT02226796
Recruitment Status : Recruiting
First Posted : August 27, 2014
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
We hypothesize patients who have difficulty with word recall (naming pictures) due to a stroke will experience greater benefit in word recall after receiving a combination of transcranial direct current stimulation (tDCS) and traditional behavioral treatment. This study will investigate the effects of the timing of tDCS in relationship to the behavioral treatment to determine the most optimal protocol. Transcranial direct current stimulation involves placing two electrodes on your scalp and sending a very small electrical current to excite the brain cells of the target site.

Condition or disease Intervention/treatment Phase
Aphasia Device: transcranial direct current stimulation Prime Condition Other: Non-Prime Condition Behavioral: Traditional behavioral treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Combination of Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Non-fluent Aphasia
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia

Arm Intervention/treatment
Active Comparator: Prime Condition
The primed (PRIME) condition is an intervention that will consist of presentation of a-tDCS for 20 minutes prior to naming treatment, while the subject sits quietly and comfortably in a chair. After the 20-minute priming period, the a-tDCS will be removed and the participant will receive naming treatment for 60 minutes.
Device: transcranial direct current stimulation Prime Condition
Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.
Other Name: Transcranial Technologies, TCT Research Limited

Behavioral: Traditional behavioral treatment
Active Comparator: Non-Prime Condition
The non-prime (NONPRIME) condition is an intervention that will consist of 40 minutes of naming treatment only, followed by an additional 20 minutes of concurrent naming treatment with a-tDCS.
Other: Non-Prime Condition
Behavioral: Traditional behavioral treatment



Primary Outcome Measures :
  1. Boston Naming Test [ Time Frame: 30 minutes ]
    Standardized test of word recall


Secondary Outcome Measures :
  1. Naming Reaction Time [ Time Frame: 20 minutes ]
    Document the amount of time it takes for the patient to identify the picture

  2. Working memory [ Time Frame: 20 minutes ]
    Various working memory tasks



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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • completion of high school or GED, normal or corrected-to-normal vision, adequate hearing acuity for 1:1 conversational exchanges, use of English as primary language, a vascular lesion in the dominant left hemisphere verified by an MRI scan within six months of the start of the study

Exclusion Criteria:

  • no previous history of neurological- or psychiatric-based illnesses or disease, language or learning disabilities, or alcohol/substance abuse; no history of seizures; no metal implants in the head (except dental fillings); no lesion in the left DLPFC confirmed by MRI; no current pregnancy.

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): NCT02226796


Contacts
Contact: Naomi Hashimoto, PhD 715-425-3801 naomi.hashimoto@uwrf.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Sharyl A Samargia, PhD University of Minnesota and University of Wisconsin

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02226796     History of Changes
Other Study ID Numbers: tDCSandaphasia
First Posted: August 27, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The protocol for sharing individual participant data with other researchers has not yet been determined as data collection is in progress.

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: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Broca's Aphasia
Transcranial Direct Current Stimulation

Additional relevant MeSH terms:
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms