Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia

Official title

Personalized Transcranial Magnetic Stimulation and Constraint Induced Language Therapy to Treat Mild Post-Stroke Aphasia

Overview

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

• Device Transcranial 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.
• Behavioral Speech-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 recei

Primary outcome measures

• Sentence Processing [Time frame: From baseline to 4 months post-intervention]

Secondary outcome measures (2)

• Semantic and Phonological Processing [Time frame: From baseline to 4 months post-intervention]
• Elicited Speech [Time frame: From baseline to 4 months post-intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT06842745 · 857363 · 1R21DC021833-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗