- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02226796
Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Aphasia
Effects of a Combination of Transcranial Direct Stimulation (tDCS) and Behavioral Intervention in Non-fluent Aphasia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Specific Aims Aim 1: Identify and quantify the effects of a-tDCS to the left dorsolateral prefrontal cortex (DLPFC) in conjunction with intensive behavioral treatment on naming in non-fluent aphasia. a-tDCS (2mA for 20 minutes) will be applied over the left DLPFC with cathode over the right orbit. Pre and post treatment behavioral measures of naming and working memory will be used to quantify and compare differences. Hypothesis 1: a-tDCS will result in improvements in naming accuracy, naming response times, and working memory (WM) in participants with non-fluent aphasia.
Aim 2: Compare the effects of a-tDCS applied to the left DLPFC before behavioral treatment to during behavioral treatment in non-fluent aphasia. a-tDCS (2mA for 20 minutes) will be applied over the left DLPFC with cathode over the right orbit. Pre and post treatment behavioral measures of naming and working memory will be used to quantify and compare functional differences between conditions. Hypothesis 1: a-tDCS to the DLPFC during treatment will result in a greater improvement of naming accuracy, naming response time and WM in participants with non-fluent aphasia.
Significance The findings from the proposed study will lay the foundation for a larger clinical trial which will in turn have a significant impact on individuals with aphasia given that naming deficits are a common symptom in this population. As the presence of naming deficits has a negative relationship to emotional well-being and functional communication 26-30, treatment that improves naming deficits will positively influence quality of life in many of these individuals. The approach taken to remediate naming deficits in aphasia is to treat impaired WM systems on the premise that certain cognitive processes underlie linguistic functions in aphasia. This approach represents a departure from most behavioral-based naming treatment approach, but reflects a growing recognition that WM systems in individuals with aphasia impact their linguistic performance 5, 31. The addition of a-tDCS as a neuromodulation tool to increase cortical excitability (upregulate) the working memory center to target naming is a novel approach. In addition, this study will further elucidate the optimal timing of a-tDCS in order to achieve the most beneficial outcomes, which have not yet been reported. These findings, along with other related studies, will shape future clinical practice guidelines as more studies adopt a concurrent cognitive-linguistic approach to treat linguistic deficits in aphasia.
Design & Methodology Participants. Four individuals with aphasia will be recruited. These participants must meet the following inclusionary/exclusionary criteria: a) completion of high school or GED; b) normal or corrected-to-normal vision; c) adequate hearing acuity for 1:1 conversational exchanges; d) use of English as primary language; e) a vascular lesion in the dominant left hemisphere verified by an MRI scan within six months of the start of the study. These participants must also meet the following exclusionary criteria: a) no previous history of neurological- or psychiatric-based illnesses or disease, language or learning disabilities, or alcohol/substance abuse; b) no history of seizures; c) no metal implants in the head (except dental fillings); d) no lesion in the left DLPFC confirmed by MRI; e) no current pregnancy. Pre-Test Behavioral Measures. Participants will be seen between 2-3 sessions to undergo comprehensive cognitive-linguistic testing prior to initiation of treatment. Testing will take place at the University of Minnesota (UMN) Clinical Translational Science Institute (CTSI). Behavioral test measures will include the WAB 32 in order to obtain the WAB Aphasia Quotient (WAB AQ), Boston Naming Test (BNT) 33 and the Apraxia Battery for Adults (ABA-2) 34. The WAB AQ will provide a general classification of aphasia subtype, scores from the BNT will provide the level of severity of naming impairment, and ABA-2 performance will be used to assess severity of apraxia of speech (AoS). To assess the integrity of the phonological store, participants will be tested for the effects of phonological similarity using both auditory and visual presentation 35, 36. To assess the integrity of subvocal rehearsal processes, participants will be tested for the effects of word length on both auditory and visual span 37; the effects of articulatory suppression on recall performance 37, 38; and rhyme judgments 39-41. Protocols that have been adapted for individuals with aphasia will be followed42-45. These tests will be used to distinguish behavioral evidence of deficient subvocal rehearsal processes from deficient phonological short-term store. Individuals with a range of moderate to moderately severe nonfluent aphasia, a range of moderate to moderately severe anomia, and a range of mild to no AoS will be chosen for the study. Baseline probes will also be obtained prior to the initiation of the study. Stability of baseline performance, defined as no more than 20% difference between scores,will be obtained over three consecutive sessions in order to establish experimental control. Post-Test Behavioral Measures. Participants will also be seen for post-treatment testing following the implementation of the treatment protocol. Testing will take place in the participant's home. Post-treatment behavioral measures will include BNT, the ABA-2, WM tasks, and naming treatment and control items. It is anticipated that only one session will be needed for post-treatment testing. An adverse events survey will also be provided to assess the participant's level of discomfort during use of tDCS. tDCS Protocol. Each participant will be seated comfortably in a chair. A swim cap will be placed on the participant's head to identify cranial landmarks for accurate electrode placement. The area referred to as F3 by the International 10/20 system for electroencephalogram electrode placement46 has been established as the optimal location for targeting the left DLPFC25, 47-49. The F3 region will be located by marking the vertex (the midpoint between left and right tragus and midpoint between nasion and inion), measuring the head circumference. When these measurements are entered into the Beam F3 Locator Software50, additional values are provided to reliably identify the location of F3. Once F3 has been established, two saline soaked surface sponge electrodes (352cm) will be prepared and placed. For optimal anodal stimulation to the DLPFC, the anode will be placed over F3 and the cathode will be placed over the right supraorbital region23, 24, 47, 48. A current of 2mA will be delivered for 20 minutes 24 by a multichannel transcranial current stimulator (Starstim, Neuroelectrics Corporation; Cambridge, MA). a-tDCS will be applied before and during behavioral treatment in the design specified below.
Treatment Design. Two treatment conditions will be presented in a counter-balanced order in a cross-over design. The non-prime (NONPRIME) condition will consist of 40 minutes of naming treatment only, followed by an additional 20 minutes of concurrent naming treatment with a-tDCS. The primed (PRIME) condition 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. Both conditions will be presented over four consecutive days. Two participants will receive NON-PRIME-PRIME sequence, with a one-month washout period between the two conditions. Two other participants will receive PRIME-NON-PRIME sequence, with a one-month washout period between the two conditions. Naming reaction time will be immediately evaluated after each treatment day.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55455
- University of Minnesota
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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 to the dorsolateral prefrontal cortex prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
|
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.
|
Active Comparator: Non-Prime Condition/Control
The non-primed (NON-PRIME) condition, or sham controlled, is an intervention that will consist of presentation of sham tDCS to the dorsolateral prefrontal cortex for 20 minutes prior to 40 minutes of behavioral naming treatment, while the subject sits comfortably in a chair.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Naming Reaction Time
Time Frame: 40 minutes
|
Participants are shown one or 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect.
Each bank contains 15 items.
Time to recall is measured using a stop watch.
The mean time to recall across all items is calculated and reported in milliseconds.
The smaller the number, the faster / better the reaction time is.
|
40 minutes
|
Naming Accuracy
Time Frame: 40 minutes
|
Participants are shown one of 3 possible banks of pictures balanced for phonemic complexity which are randomly assigned to prevent learning effect.
Each bank contains 15 items.
Each trial is scored by an examiner as accurate (1) or inaccurate (0) based on articulatory accuracy of the participant's response.
The average of all trials is calculated for each participant.
Total scores range from 0-15 with higher scores indicating better naming accuracy/performance.
|
40 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Boston Naming Test
Time Frame: 30 minutes
|
The Boston Naming Test contains 60 line drawings of objects ranging from very common objects to less familiar.
The examiner scores each item + or - according to scoring procedures.
Total scores are calculated by adding up the number correct.
Scores range from 0 to 60. Higher scores indicate greater ability to name objects.
|
30 minutes
|
Western Aphasia Battery Total Score
Time Frame: 60 minutes
|
The Western Aphasia Battery, a standardized assessment of language for individuals with aphasia, contains 32 short tasks.
Each task has a separate scoring scheme yielding 8 sub-scores.
Total score range from 0-100 with lower scores indicating greater aphasia severity.
A score between 0-25 is very severe aphasia, 26-50 is severe aphasia, 51-75 is moderate aphasia, and 76-above is mild aphasia.
|
60 minutes
|
Working Memory Total Score
Time Frame: 2 months
|
During the Working Memory battery, participants complete 12 auditory only or auditory & visual computer-based recall tasks.
Twelve subset scores are calculated.
Ten subtest ranges from 0-40 and 2 range from 0-60.
Total score is calculated as sum of subtest scores and ranges from 0-520 with higher scores indicating greater working memory.
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sharyl A Samargia, PhD, University of Minnesota and University of Wisconsin
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1506M73043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aphasia
-
University of South CarolinaNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Aphasia | Stroke, Ischemic | Aphasia, Broca | Aphasia, Anomic | Aphasia, Global | Aphasia, Fluent | Aphasia, Mixed | Aphasia, Jargon | Aphasia, Expressive | Aphasia, ConductionUnited States
-
University of Texas at AustinUniversity of California, San Francisco; National Institute on Deafness and...Active, not recruitingPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Semantic Memory Disorder | Nonfluent Aphasia, Progressive | Aphasia, ProgressiveUnited States
-
Institute for Bioengineering of CataloniaHospital Universitari Joan XXIII de Tarragona.; Universitat Pompeu FabraCompletedAphasia | Aphasia, Broca | Aphasia, Wernicke | Aphasia, Fluent | Aphasia, NonfluentSpain
-
Flint Rehabilitation Devices, LLCUniversity of TexasCompleted
-
Mayo ClinicNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingPrimary Progressive Aphasia | Apraxia of Speech | PPA | Non-fluent Aphasia | Primary Progressive Non-fluent AphasiaUnited States
-
University of California, BerkeleyUniversity of California, San Francisco; California State University, East Bay and other collaboratorsRecruitingAphasia | Aphasia, Acquired | Aphasia Non Fluent | Aphasia, FluentUnited States
-
Mayo ClinicCompletedPrimary Progressive Aphasia | Aphasia | Semantic Dementia | Apraxia of Speech | Primary Progressive Nonfluent Aphasia | PPA | Non-fluent Aphasia | Progressive AphasiaUnited States
-
Montreal Heart InstituteActive, not recruitingNeurodegenerative Diseases | Primary Progressive Aphasia | Semantic Dementia | Logopenic Progressive Aphasia | Non-fluent AphasiaCanada
-
Johns Hopkins UniversityNational Institute on Aging (NIA)RecruitingPrimary Progressive Aphasia | Logopenic Progressive Aphasia | Non-Fluent Primary Progressive AphasiaUnited States, Canada
-
University of British ColumbiaTerminatedPrimary Progressive Nonfluent AphasiaCanada
Clinical Trials on Transcranial direct current stimulation
-
Federal University of ParaíbaCompleted
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development...Recruiting
-
University of Campinas, BrazilUnknownEpilepsy IntractableBrazil
-
Dina Hatem ElhammadyUnknown
-
Shirley Ryan AbilityLabNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedStroke | Nonfluent AphasiaUnited States
-
University of Texas Rio Grande ValleyRecruitingSpinal Cord Diseases | Spinal Cord InjuriesUnited States
-
Federal University of ParaíbaUnknown
-
University of CalgaryAlberta Health servicesRecruitingCervicogenic HeadacheCanada
-
Universidade Federal do Rio Grande do NorteNot yet recruitingLow Back Pain | Transcranial Direct Current Stimulation
-
Nanyang Technological UniversityActive, not recruiting