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Stimulating Language in Subacute StrokE (SLISSE)

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ClinicalTrials.gov Identifier: NCT02674490
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
University of South Carolina
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS) is a promising adjunct to traditional SALT. 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. Most studies are conducted in the chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is reason to believe tDCS might be most effective in the acute-subacute period. However, only two studies have evaluated tDCS paired with language therapy in group studies of acute to subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the investigators will evaluate whether tDCS combined with SALT improves naming in individuals with aphasia in the acute and subacute post stroke period, more than SALT alone in a randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computer-delivered SALT in post stroke aphasia.

Condition or disease Intervention/treatment Phase
Stroke Device: A-tDCS (1 mA) Behavioral: SALT Device: Sham Not Applicable

Detailed Description:
After informed consent is received, a neurological examination will be performed and multiple screening assessments will be conducted including a tDCS and MRI safety screening. If the participant passes the initial screening portion, speech and language diagnostic testing will be conducted during the same visit (Visit 1). During the next visit (Visit 2), participants will undergo a second baseline assessment of naming ability and assessment of connected speech. On that visit, participants who have no contraindication for MRI (and agree to have MRI) will be randomized to (1) fMRI electrode placement or (2) structural electrode placement. All participants who have no contraindication will have structural and resting state functional connectivity MRI (rsfcMRI). Those randomized to fMRI electrode placement will also participate in the naming paradigm during the MRI. The third visit will include electrode positioning and tDCS treatment administration. Participants will receive 15 sessions (Visits 3-17) of tDCS + SALT administration. At the beginning of Visit 3, eligible participants will be randomized to receive either A-tDCS (1 mA) or sham-tDCS (placebo) for 15 sessions (20-minutes per each 45-minute behavioral treatment session) over the course of three weeks. A computer-delivered naming treatment will be coupled with the stimulation. The computer-delivered treatment task will be 45-minutes in total length, so that it will commence at the same time as the tDCS administration and continue for another 25-minutes after the tDCS has ceased. To assess cardiovascular arousal, blood pressure and heart rate will be measured before and after each session. Additionally, discomfort ratings will be recorded following the end of each session using the Wong-Baker FACES Pain Rating Scale and a weekly neurological exam will be administered by a neurologist. Neither the participant nor the clinician monitoring and setting up the treatment will have knowledge of the treatment condition (A-tDCS versus sham). Utilizing a computerized picture naming assessment, all participants will be assessed at several different time points throughout the experiment: twice immediately before and twice the week immediately following the fifteenth and final treatment session; twice at five weeks follow-up after the end of treatment; and twice at 20 weeks after the end of treatment. Participants who agree to participate in the MRI portion of the study (and have none of the additional exclusion criteria for MRI) will have structural and rsfcMRI at Visit 2, following the 15th treatment session (Week 1 after the end of treatment), and at 5 weeks after the end of treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy for Naming in Subacute Left Hemisphere Stroke
Study Start Date : April 1, 2016
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aphasia Sodium

Arm Intervention/treatment
Experimental: A-tDCS & SALT
A-tDCS (1 mA) plus Speech and Language Treatment (SALT) for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. The electrical current will be administered to a pre-specified region of the brain. The stimulation will be delivered at an intensity of 1mA for a maximum of 20 minutes. SALT will be a computer-delivered naming + picture matching task .
Device: A-tDCS (1 mA)
1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
Other Name: Anodal transcranial direct current stimulation

Behavioral: SALT
Computer-delivered naming treatment requires matching word (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 response button if the word does not match the picture.
Other Name: Speech and Language Treatment

Sham Comparator: Sham-tDCS & SALT
Sham-tDCS plus SALT for 15 sessions (20-minutes per each 45-minute treatment session) over the course of 3 weeks. Current will be administered in a ramp-like fashion, but after the ramping, the intensity will drop to 0 mA. SALT will be a computer delivered oral naming + picture naming task.
Behavioral: SALT
Computer-delivered naming treatment requires matching word (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 response button if the word does not match the picture.
Other Name: Speech and Language Treatment

Device: Sham
1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 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.
Other Name: Sham-tDCS




Primary Outcome Measures :
  1. Change in accuracy of naming untrained pictures (Philadelphia Naming Test) pre- to post-treatment [ Time Frame: Change is averaged over 2 sessions (to reduce variability) on 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment. ]
    To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition).


Secondary Outcome Measures :
  1. Change in accuracy of naming untrained pictures (Philadelphia Naming Test) pre- -treatment to 5-weeks and 20-weeks post-treatment [ Time Frame: The PNT will be administered at baseline and at 5 and 20 weeks post treatment. ]
    To determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia for a greater duration than SALT alone (i.e., the sham condition).

  2. Change in content of picture description pre- to post-treatment [ Time Frame: Immediately before and within 1 week after treatment ]
    The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls. This measure provides a sensitive measure of content of narrative speech in all levels of aphasia.

  3. Change in efficiency of picture description pre- to post-treatment [ Time Frame: Immediately before and within 1 week after treatment ]
    The investigators will also determine number of syllables/content unit (CU) in the Cookie Theft description. This measure provides a sensitive measure of efficiency of narrative speech in all levels of aphasia.

  4. Change in content of picture description pre-treatment to 5 weeks and 20-weeks post-treatment [ Time Frame: Immediately before and at 5 weeks and 20 weeks after treatment ]
    The investigators will also record the description of the "Cookie Theft" picture during administration of the National Institutes of Health Stroke Scale before and after treatment, and count the number of Content Units (CU) mentioned by healthy controls.

  5. Change in efficiency of picture description pre-treatment to 5 weeks and 20-weeks post-treatment [ Time Frame: Immediately before and at 5 weeks and 20 weeks after treatment ]
    The investigators will also evaluate the syllables/CU in the description of the "Cookie Theft" picture as a measure of efficiency of narrative speech.

  6. Change in Stroke Impact Scale (SIS) pre-treatment to post-treatment [ Time Frame: Immediately before and within 1 week after treatment ]
    The SIS will be administered at baseline and within 1 week after treatment to evaluate changes in quality of life and social engagement.

  7. Change in Stroke Impact Scale (SIS) pre-treatment to 5 weeks and 20 weeks post-treatment [ Time Frame: Immediately before and 5 and 20 weeks after treatment ]
    The SIS will be administered at baseline and 5 and 20 weeks after treatment to evaluate any lasting changes in quality of life and social engagement.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant Inclusion Criteria

Participants must satisfy the following inclusion criteria to be considered eligible for entry into this study:

  1. Participants must have sustained an acute ischemic left hemisphere stroke.
  2. Participants must be fluent speakers of English by self-report.
  3. Participants must be capable of giving informed consent or indicating another to provide informed consent.
  4. Participants must be age 18 or older.
  5. Participants must be premorbidly right handed.
  6. Participants must be within 3 months of onset of stroke.
  7. Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
  8. Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts

Exclusion Criteria:

  • Participant Exclusion Criteria

Participants with any of the following characteristics will not be eligible for entry into this study:

  1. Previous neurological or psychiatric disease, including previous symptomatic stroke.
  2. Seizures during the previous 12 months.
  3. Uncorrected visual loss or hearing loss by self-report.
  4. Use of medications that lower the seizure threshold (e.g., methylphenidate, amphetamine salts).
  5. Use of NMDA antagonists (e.g., memantine).
  6. History of brain surgery or any metal in the head.
  7. Scalp sensitivity (per participant report).

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): NCT02674490


Contacts
Contact: Argye B Hillis-Trupe, MD, MA 410-614-2381 argye@jhmi.edu
Contact: Donna C Tippett, MPH, MA 410-955-7895 dtippet1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205
Contact: Argye B Hillis, MD    410-614-2381    argye@jhmi.edu   
Contact: Donna Tippett, MA, MPH    410-502-6045      
Sponsors and Collaborators
Johns Hopkins University
University of South Carolina
Investigators
Principal Investigator: Argye B Hillis-Trupe, MD, MA Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02674490     History of Changes
Other Study ID Numbers: IRB00089018
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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).

Keywords provided by Johns Hopkins University:
aphasia, language

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases