Transcranial Magnetic Stimulation + Language Therapy for Aphasia

Overseen By Daniela Sacchetti, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Pennsylvania

Disqualifiers: Substance abuse, Psychiatric illness, Dementia, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 14

Duration: 2 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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

Who Is on the Research Team?

H. Branch Coslett, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for individuals who have had a stroke and are experiencing aphasia, which affects their ability to communicate. They must be in the subacute stage after their stroke and able to undergo MRI scans. Participants will need to commit to daily sessions over two weeks and follow-up assessments.

Inclusion Criteria

English proficiency

Right-handed

I had a stroke in the left side of my brain causing speech difficulties.

Exclusion Criteria

I've had a head injury that knocked me out for over 5 minutes.

Pregnancy

History of serious and/or ongoing issues with substance abuse

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo MRI scans and a battery of tests to define their language function

1 week

1 visit (in-person)

Treatment

Participants receive 10 consecutive sessions of TMS and mCILT treatment

2 weeks

10 visits (in-person)

Immediate Follow-up

Participants complete follow-up assessments immediately after treatment

1 week

1 visit (in-person)

Long-term Follow-up

Participants are monitored for language function 4 months after treatment

4 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Modified Constraint Induced Language Therapy (mCILT)
• Transcranial Magnetic Stimulation (TMS)

Trial Overview The study tests if Transcranial Magnetic Stimulation (TMS) combined with modified Constraint Induced Language Therapy (mCILT) can improve speech in people with aphasia post-stroke. It compares real TMS with sham TMS, using electric field guided technology for personalized treatment intensity and targeting.

How Is the Trial Designed?

Group I: Real TMS Experimental Treatment 2 Interventions

Some of our participants will be randomized to the real treatment arm where they will receive 10 sessions of real TMS paired with language therapy.

Group II: Fake TMS Placebo Group 1 Intervention

Some of our participants will be randomized to the sham treatment arm where they will receive 10 sessions of fake TMS paired with language therapy.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+