Cerebellar Transcranial Direct Current Stimulation and Aphasia Treatment
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ClinicalTrials.gov Identifier: NCT02901574 |
Recruitment Status :
Recruiting
First Posted : September 15, 2016
Last Update Posted : August 13, 2020
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Tracking Information | |||||
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First Submitted Date ICMJE | September 6, 2016 | ||||
First Posted Date ICMJE | September 15, 2016 | ||||
Last Update Posted Date | August 13, 2020 | ||||
Study Start Date ICMJE | August 2016 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in accuracy of naming untrained pictures (Philadelphia Naming Test:PNT) pre- to post-treatment. [ Time Frame: Before and after 15 sessions (3-5 sessions per week; up to 5 weeks) of treatment. ] To determine whether tDCS coupled with computerized naming therapy will improve naming performance of participants with post stroke aphasia more effectively than naming therapy alone (i.e., the sham condition).The PNT is a 175-item picture naming test developed for the psycholinguistic exploration of lexical access in nonaphasic and aphasic speakers and the score can range from 0-175, where a score of 0/175 indicates 0 percent correct and a score of 175/175 indicates 100 percent correct.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Cerebellar Transcranial Direct Current Stimulation and Aphasia Treatment | ||||
Official Title ICMJE | Cerebellar Transcranial Direct Current Stimulation to Augment Chronic Aphasia Treatment | ||||
Brief Summary | People with post-stroke aphasia are left with some degree of chronic deficit for which current rehabilitative treatments are variably effective. This study investigates the behavioral and neural effects of multiple consecutive cerebellar tDCS sessions coupled with computerized naming therapy in stroke survivors with aphasia. | ||||
Detailed Description | The investigators will study the effect of right cerebellar transcranial direct current stimulation (tDCS) stimulation during language therapy for naming in individuals with chronic aphasia (>6 months post stroke). Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Although the interventions to improve naming can have benefits, a massive number of treatment sessions is usually required to show gains, particularly in individuals with chronic, large LH stroke. tDCS is a promising adjunct to traditional language therapy. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Prior investigators have mainly focused on the role of LH in language recovery, wherein the electrode is placed in the left frontal or temporal region. However, in individuals with large lesions involving key language areas like the frontal and temporal cortex, it may be difficult to find viable tissue to stimulate in the LH. This study uses a novel electrode placement for chronic stroke patients with aphasia with large LH lesions. Targeting the intact right cerebellum allows for the possibility of identifying a single target that can be used across groups of people with aphasia with varying lesion sites and size in the LH. Evidence from functional neuroimaging and clinical studies indicate that the right cerebellum is important for both language and cognitive functions. The investigators will utilize a randomized, double-blind, sham controlled, within-subject crossover trial design. A random subset (half) of participants will be assigned to the "anode" group (Group Anode) and other half will be assigned to the 'cathode' group (Group Cathode). Participants will take part in 2 intervention periods of 15 computerized naming training sessions (3-5 sessions per week), with either tDCS + naming therapy or sham+ naming therapy, separated by 2 months. Detailed language evaluation will take place before, immediately after, 2 weeks and 2 months post-intervention for each condition. The investigators will test the hypothesis that anodal tDCS or cathodal tDCS over the cerebellum and computerized naming therapy is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computerized naming therapy. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Stroke | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
50 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | December 2021 | ||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02901574 | ||||
Other Study ID Numbers ICMJE | IRB00100024 R00DC015554 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | Johns Hopkins University | ||||
Study Sponsor ICMJE | Johns Hopkins University | ||||
Collaborators ICMJE | National Institute on Deafness and Other Communication Disorders (NIDCD) | ||||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||
Verification Date | August 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |