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
Qualifiers
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
Treatments tested in this trial
- Transcranial Magnetic Stimulation (TMS)
- Modified Constraint Induced Language Therapy (mCILT)
Treatment groups
63 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov