Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Pennsylvania
About this trial
The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with modified Constraint Induced Language Therapy (mCILT) is an effective treatment for aphasia when delivered in the subacute stage after stroke.
The main questions this study aims to answer are:
1. Can TMS combined with mCILT improve overall speech? 2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and mCILT treatment?
Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat subacute aphasia.
Importantly, this trial will use electric field guided TMS to identify optimal and individualized stimulation intensity and site targeting.
Participants will:
* Complete a screening and medical intake to determine eligibility * Undergo MRI scans * Participate in 10 consecutive sessions (Monday-Friday) of TMS and mCILT treatment * Complete follow-up assessments immediately and 4 months after treatment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Left hemisphere stroke resulting in aphasia
The stroke must have occurred between 2 and 6 weeks prior to enrollment
Must be able to understand the nature of the study, and give informed consent
English proficiency
Disqualifiers
History of serious and/or ongoing issues with substance abuse
Previous head trauma with loss of consciousness for more than 5 minutes
History of major psychiatric illness
Dementia, or other neurological conditions
Trial design
Design model
Parallel
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS)
DeviceTMS, 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.
Modified Constraint Induced Language Therapy (mCILT)
BehavioralConstraint-induced language therapy (CILT) is a treatment approach for aphasia that focuses on forcing the patient to use their impaired language skills, while restricting the use of compensatory strategies like gestures or writing. All participants will receive mCILT.
Treatment groups
63 Participants
are divided into 2 treatment groupsGroup A: Real TMSExperimental treatment 2 interventions
Group B: Fake TMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall language function
Change in performance on the Western Aphasia Battery (WAB-AQ score). WAB AQ Score is out of 100, where a higher score means less language impairment.
Time frame
From Baseline to 4 months post-interventionsSponsors and contacts
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Source ClinicalTrials.gov