Timing of Transcranial Direct Current Stimulation (tDCS) Combined With Speech and Language Therapy (SLT)
1 other identifier
interventional
48
1 country
1
Brief Summary
Aphasia is an acquired (typically left-hemisphere) multi-modality disturbance of language that impacts around 2 million people in the USA. Aphasia impacts language production and comprehension as well as reading and writing. The ramifications of aphasia extend beyond language impairment to negatively impacting a person's social, vocational, and recreational activities. Currently, the most effective way to treat aphasia is with speech-language therapy (SLT). However, even if SLT is intensive, persons with aphasia are left with residual language delays. Recent research suggests that pairing SLT with transcranial direct current stimulation (tDCS) a non-invasive, safe, low-cost form of brain stimulation may aid language recovery in persons with aphasia. However, results from tDCS studies are inconclusive. The success of tDCS in combination with SLT could depend on the timing of tDCS since tDCS-induced effects depend on the neuronal state of the brain-networks at the time of the stimulation. In this study, the differential impact of tDCS before behavioral SLT (offline-before therapy), tDCS after SLT (offline-after therapy), and tDCS concurrently with SLT (online) on functional language recovery in persons with aphasia will be investigated. Sham tDCS (i.e., SLT alone) as a control group will also be included in the study. The investigators hypothesize that both offline and online tDCS will improve language functioning than sham tDCS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedStudy Start
First participant enrolled
April 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 26, 2022
July 1, 2022
3.7 years
December 10, 2018
July 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in trained conversational script.
Changes in accuracy and rate of production on a trained conversational script from pre to post-treatment.
3 weeks.
Secondary Outcomes (4)
Change in untrained conversational script
3 weeks
Change in the Aphasia Quotient (AQ) of Western Aphasia Battery-Revised (WAB-R)
3 weeks
Maintenance of trained conversational script
7 weeks
Maintenance of trained conversational script
11 weeks
Study Arms (4)
Offline tDCS-before therapy
ACTIVE COMPARATORParticipants will receive 20 minutes of tDCS prior to the 40 minute speech-language therapy session.
Offline tDCS-after therapy
ACTIVE COMPARATORParticipants will receive 20 minutes of tDCS after the 40 minute speech-language therapy session.
Online tDCS
ACTIVE COMPARATORtDCS will be applied at the beginning of the 40 minute speech-language therapy session and will last for 20 minutes.
Sham tDCS
SHAM COMPARATORSham tDCS will be applied at the beginning of the 40 minute speech-language therapy session.
Interventions
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Stimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
Eligibility Criteria
You may qualify if:
- Men or women with diagnosis of fluent or non-fluent aphasia subsequent to a left-hemisphere infarct(s) that is confirmed by a MRI or CT scan
- Aphasia quotient on the WAB of 35-85
- At least 6 months post onset of aphasia (this is beyond the stage of spontaneous recovery)
- years of age
- Premorbidly fluent in English
- Premorbidly right-hand dominant per the Edinburg Handedness Inventory
- Visual acuity of 20/40 corrected
- Auditory acuity no worse than 30 dB HL on pure tone testing, aided in the better ear.
- Education greater than 12th grade
You may not qualify if:
- Any other neurological condition (other than cerebral vascular disease) that could impact language and cognition such as Alzheimer's disease, Parkinson's disease, primary progressive aphasia, and traumatic brain injury
- Active substance use
- Individuals with epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
Related Publications (1)
Ashaie SA, Engel S, Cherney LR. Timing of transcranial direct current stimulation (tDCS) combined with speech and language therapy (SLT) for aphasia: study protocol for a randomized controlled trial. Trials. 2022 Aug 17;23(1):668. doi: 10.1186/s13063-022-06627-9.
PMID: 35978374DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leora Cherney, PhD
Shirley Ryan AbilityLab
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 10, 2018
First Posted
December 12, 2018
Study Start
April 3, 2019
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
July 26, 2022
Record last verified: 2022-07