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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 : June 18, 2018
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE September 6, 2016
First Posted Date  ICMJE September 15, 2016
Last Update Posted Date June 18, 2018
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
 (submitted: September 9, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02901574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2016)
  • Change in accuracy of naming untrained pictures (PNT) pre- treatment to 2 weeks post treatment. [ Time Frame: The PNT will be administered at pre-treatment and at 2 weeks post treatment (tDCS and sham) ]
    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).
  • Change in accuracy of naming untrained pictures (PNT) pre- treatment to 2 months post treatment [ Time Frame: The PNT will be administered at pre-treatment and at 2 months post treatment (tDCS and sham) ]
    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).
  • Change in functional communication skills pre- treatment to post treatment. [ Time Frame: Before and after 15 sessions of treatment (tDCS and sham) ]
    The Functional Assessment of Communication Skills for Adults (ASHA FACS) will be administered pre- treatment and post treatment to evaluate changes in functional communication skills. The ASHA FACS is used for measuring the functional communication of adults with speech, language, and cognitive communication disorders. The ASHA-FACS is subdivided into 2 scales: Communicative Independence and Qualitative Dimensions of Communication. The Communicative Independence Scale is rated on a 7-point scale ranging from 1) "does not perform the behavior" to 7) "does perform the behavior". The Qualitative Dimensions of Communication Scale is rated on a 5-point scale reflecting adequacy, appropriateness, and promptness of communication and communication sharing.
  • Change in functional communication skills pre- treatment to 2 weeks post-treatment. [ Time Frame: Pre- treatment and at 2 weeks post treatment (tDCS and sham) ]
    The Functional Assessment of Communication Skills for Adults (ASHA FACS) will be administered pre-treatment and 2 weeks post-treatment to evaluate any lasting changes in functional communication skills.
  • Change in functional communication skills pre- treatment to 2 months post treatment. [ Time Frame: Pre- treatment and at 2 months post treatment (tDCS and sham) ]
    The Functional Assessment of Communication Skills for Adults (ASHA FACS) will be administered pre- treatment and 2 months post-treatment to evaluate any lasting changes in functional communication skills.
  • Change in lexical features of picture description pre- treatment to post treatment. [ Time Frame: Before and after 15 sessions of treatment (tDCS and sham) ]
    The Cinderella story will be administered to compare changes in lexical diversity for nouns, verbs and adjectives pre- treatment to post treatment.
  • Change in lexical features of picture description pre- treatment to pre- treatment to 2 weeks post-treatment. [ Time Frame: Pre- treatment and at 2 weeks post treatment (tDCS and sham) ]
    The Cinderella story will be administered to compare changes in lexical diversity for nouns, verbs and adjectives pre- treatment to 2 weeks post treatment.
  • Change in lexical features of picture description pre- treatment to 2 months post treatment. [ Time Frame: Pre- treatment and at 2 months post treatment (tDCS and sham) ]
    The Cinderella story will be administered to compare changes in lexical diversity for nouns, verbs and adjectives pre- treatment to 2 months post treatment.
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.

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
Condition  ICMJE Stroke
Intervention  ICMJE
  • Device: Anodal or Cathodal tDCS
    2 mA or Anodal or Cathodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge (anode in group anode or cathode in group cathode) is placed on the right cerebellum. The stimulation will be delivered at an intensity of 2 mA in a ramp-like fashion for a maximum of 20 minutes.
  • Device: Sham
    2 mA of Anodal tDCS or Cathodal tDCS is induced between two 5cm X 5cn saline soaked sponges where one sponge (anode in group Anode and cathode in group Cathode) is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
  • Behavioral: Computerized naming therapy
    Computer delivered naming treatment requires matching (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red button if the word does not match the picture.
Study Arms  ICMJE
  • Active Comparator: tDCS plus computerized naming therapy
    Anodal or cathodal tDCS, 2 milliamps (mA) plus computerized naming treatment for 15 sessions (20 minutes per each 45 minute treatment session) over the course of 3-5 weeks.The electrical current will be administered to the right cerebellum. The stimulation will be delivered at an intensity of 2 mA for a maximum of 20 minutes. Language therapy will be a computer delivered naming +picture matching task.
    Interventions:
    • Device: Anodal or Cathodal tDCS
    • Behavioral: Computerized naming therapy
  • Sham Comparator: Sham plus computerized naming therapy
    Sham tDCS plus computerized naming treatment for 15 sessions (20 minutes per each 45 minute treatment session) over the course of 3-5 weeks. Current will be administered in the in a ramp like fashion for 15-30 seconds but then the current is gradually decreased and drop to 0 mA. Language therapy will be a computer delivered naming +picture matching task.
    Interventions:
    • Device: Sham
    • Behavioral: Computerized naming therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 9, 2016)
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:

  • Participants must have sustained a left hemisphere stroke.
  • Participants must be fluent speakers of English by self-report.
  • Participants must be capable of giving informed consent or indicating another to provide informed consent.
  • Participants must be age 18 or older.
  • Participants must be premorbidly right handed.
  • Participants must be at least 6 months post stroke.
  • Participants must have an aphasia diagnosis as confirmed by the Boston Diagnostic Aphasia Examination (BDAE) Short Form.
  • Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts

Exclusion Criteria:

  • Participants with lesion involving the right cerebellum
  • Previous neurological or psychiatric disease.
  • Seizures during the previous 12 months.
  • Uncorrected visual loss or hearing loss by self-report.
  • Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
  • Use of N-methyl-D-aspartate receptor (NMDA) antagonists (e.g., memantine).
  • > 80% (140 out of 175) correct responses on the Philadelphia Naming Test at baseline.
  • History of brain surgery or any metal in the head.
  • Scalp sensitivity (per participant report).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rajani Sebastian, PhD, CCC-SLP 410-502-6045 rsebast3@jhmi.edu
Contact: Donna C Tippett, MA, MPH, CCC-SLP 410-502-6045 dtippet@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02901574
Other Study ID Numbers  ICMJE IRB00100024
K99DC015554 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Upon completion of the projects and dissemination of primary study results, the analysis data files will be made available to the public, along with the final version of the study protocol, the data dictionary, and brief instructions ("read me" file). The public use data files and the accompanying documents will be made available through the National Technical Information Service (NTIS).
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP