Aphasia, Stroke, Aphasia Following Cerebral Infarction, Aphasia, Acquired
Conditions
Keywords
aphasia, stroke, non-invasive brain stimulation, Transcranial Magnetic Stimulation
Brief summary
The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with Speech-Language Therapy (SLT) is an effective treatment for mild aphasia in persons with chronic stroke. The main questions this study aims to answer are: 1. Can TMS combined with SLT improve conversational speech and comprehension? 2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and SLT treatment? Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat post-stroke mild aphasia. Participants will: * Complete a screening and medical intake to determine eligibility * Undergo a MRI * Participate in 10 consecutive sessions (Monday-Friday) of TMS and SLT treatment * Complete follow-up assessments 2 and 4 months after treatment
Detailed description
Aphasia is an acquired disorder of language that occurs in approximately 30% of individuals with stroke and impacts approximately 1 million Americans (see NINDS.NIH.gov). Current treatments for aphasia are only modestly beneficial, so there is a clear need for more efficacious therapy. Previous research has demonstrated that TMS improves language performance in persons with aphasia and the benefit has been shown to be sustained. All studies of which we are aware, however, have included participants with moderate/severe aphasia. The issue of mild aphasia has received little attention to date but as there is an increasing recognition that even very mild language deficits have important negative consequences for employment and social well-being. This study will aim to treat mild aphasia with TMS and SLT emphasizing conversations speech. One limitation of TMS has been variability in response; TMS has shown good within-subject reliability but more substantial variability between subjects. In recognition of these issues, "electrical field" (e-field) models have been developed to account for these individual differences in anatomy. We will the utilize e-field models in conjunction with an individually determined resting motor threshold to generate a personalized treatment regimen that is likely to ensure that all subjects receive the same TMS intensity relative to their individual motor threshold and greatly reduces the possibility of under- or over-dosing with respect to TMS intensity. We will employ continuous theta-burst stimulation, 600 brief electrical pulses delivered in 40 seconds, over the right front part of the brain (pars triangularis). Participants who are enrolled can expect to undergo a battery of tests to define their language function as well as a research MRI scan that will be used to guide TMS therapy and to assess the size and location of the stroke and its impact on brain pathways. After baseline testing, subjects will undergo treatment using TMS (or sham) + SLT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately, 2 months and 4 months after treatment. Participants will be compensated for their time and travel.
Interventions
DEVICETranscranial Magnetic Stimulation (TMS)
TMS, is a form of non-invasive brain stimulation, that uses magnetic pulses to stimulate specific areas of the brain. In this study we will utilize theta-burst stimulation which uses a higher frequency pulse of 50 Hz delivered for 40 seconds for a total of 600 pulses.
BEHAVIORALSpeech-Language Therapy (SLT)
Our SLT protocol draws from two theories and evidence-based cognitive-linguistic frameworks: (1) conversational alignment, which engages priming of lexical and syntactic structures through dialogue and conversation and (2) increased tolerance of memory load in the context of sentence repetition and dialogue tasks. Administration of these tasks will abide by principles of constraint-induced language therapy, i.e., intense treatment schedule and verbal responding only. All participants will receive SLT.
Sponsors
University of Pennsylvania
Temple University
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Left Hemisphere stroke * Stroke occurred more than 6 months ago * Mild Aphasia (WAB AQ score \> 85) * Proficient in English
Exclusion criteria
* Ongoing substance or alcohol abuse * Other neurological disorders, beside stroke (i.e. dementia, traumatic brain injury, multiple sclerosis) * Active psychiatric disorders (i.e. bipolar disorder, schizophrenia) * Pacemaker or cardiac defibrillator * Diagnosis of tinnitus * Epilepsy, or seizure in the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentence Processing | From baseline to 4 months post-intervention | Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Semantic and Phonological Processing | From baseline to 4 months post-intervention | Change in performance on the TALSA composite semantic processing score and phonological processing score. |
| Elicited Speech | From baseline to 4 months post-intervention | Change in performance on the Nicholas \& Brookshire picture description and Story Retell scores. |
Countries
United States
Contacts
CONTACTHarris Drachman, MS
CONTACTDaniela Sacchetti, MS
PRINCIPAL_INVESTIGATORH. Branch Coslett, MD
University of Pennsylvania
Outcome results
None listed