Stimulating Language in Subacute StrokE
SLISSE
Effects of Transcranial Direct Current Stimulation (tDCS) Plus Language Therapy for Naming in Subacute Left Hemisphere Stroke
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2016
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedStudy Start
First participant enrolled
June 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedResults Posted
Study results publicly available
September 30, 2022
CompletedMarch 10, 2023
March 1, 2023
5.4 years
January 27, 2016
August 3, 2022
March 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment
The purpose of this measure was 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). The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance. The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment.
2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment
Secondary Outcomes (11)
Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test) Pre-treatment to 5-weeks Post-treatment
The PNT will be administered at baseline and at 5 weeks post treatment.
Change in Content of Picture Description Pre-treatment to 1 Week Post-treatment
Immediately before and within 1 week after treatment
Change in Efficiency of Picture Description Pre-treatment to 1 Week Post-treatment
Immediately before and within 1 week after treatment
Change in Content of Picture Description Pre-treatment to 5 Weeks Post-treatment
Immediately before and at 5 weeks after treatment
Change in Efficiency of Picture Description Pre-treatment to 5 Weeks Post-treatment
Immediately before and at 5 weeks after treatment
- +6 more secondary outcomes
Study Arms (2)
A-tDCS & SALT
EXPERIMENTALA-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 .
Sham-tDCS & SALT
SHAM COMPARATORSham-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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Participants must have sustained an acute ischemic 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 within 3 months of onset of stroke.
- Participants must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
- Participants must achieve at least 65% accuracy on screening task (comparable to treatment task) on 1 of 3 attempts
You may not qualify if:
- Participants with any of the following characteristics will not be eligible for entry into this study:
- Previous neurological or psychiatric disease, including previous symptomatic stroke.
- 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 (NMDA) antagonists (e.g., memantine).
- History of brain surgery or any metal in the head.
- Scalp sensitivity (per participant report).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- University of South Carolinacollaborator
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Related Publications (3)
Kang JS, Bunker LD, Stockbridge MD, Hillis AE. White Matter Hyperintensities as a Predictor of Aphasia Recovery. Arch Phys Med Rehabil. 2024 Jun;105(6):1089-1098. doi: 10.1016/j.apmr.2024.01.008. Epub 2024 Jan 26.
PMID: 38281579DERIVEDStockbridge MD, Elm J, Teklehaimanot AA, Cassarly C, Spell LA, Fridriksson J, Hillis AE. Individual Differences in Response to Transcranial Direct Current Stimulation With Language Therapy in Subacute Stroke. Neurorehabil Neural Repair. 2023 Aug;37(8):519-529. doi: 10.1177/15459683231190642. Epub 2023 Aug 17.
PMID: 37592860DERIVEDStockbridge MD, Elm J, Breining BL, Tippett DC, Sebastian R, Cassarly C, Teklehaimanot A, Spell LA, Sheppard SM, Vitti E, Ruch K, Goldberg EB, Kelly C, Keator LM, Fridriksson J, Hillis AE. Transcranial Direct-Current Stimulation in Subacute Aphasia: A Randomized Controlled Trial. Stroke. 2023 Apr;54(4):912-920. doi: 10.1161/STROKEAHA.122.041557. Epub 2023 Mar 13.
PMID: 36912144DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Argye Hillis, MD
- Organization
- Johns Hopkins University School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Argye B Hillis-Trupe, MD, MA
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
February 4, 2016
Study Start
June 15, 2016
Primary Completion
November 12, 2021
Study Completion
April 1, 2022
Last Updated
March 10, 2023
Results First Posted
September 30, 2022
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
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).