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Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia

ConditionsAphasiaStrokeAphasia Following Cerebral InfarctionAphasia, Acquired
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-85
SponsorUniversity of Pennsylvania

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Left Hemisphere stroke

Stroke occurred more than 6 months ago

Mild Aphasia (WAB AQ score > 85)

Proficient in English

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Magnetic Stimulation (TMS)

    Device

    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.

  • Speech-Language Therapy (SLT)

    Behavioral

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Real TMSExperimental treatment 2 interventions
Group B: Fake TMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sentence Processing

Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score.

Time frame
From baseline to 4 months post-intervention

Secondary outcomes

1

Semantic and Phonological Processing

Change in performance on the TALSA composite semantic processing score and phonological processing score.

Time frame
From baseline to 4 months post-intervention
2

Elicited Speech

Change in performance on the Nicholas \& Brookshire picture description and Story Retell scores.

Time frame
From baseline to 4 months post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Temple University

Collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov
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