Recruiting
Phase 2

TMS & Language Therapy

Sponsor:

University of Pennsylvania

Code:

NCT06968663

Conditions

Stroke

Aphasia

Aphasia Following Cerebral Infarction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation (TMS)

Modified Constraint Induced Language Therapy (mCILT)

Study Details

Brief summary:

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

Conditions

Stroke

Aphasia

Aphasia Following Cerebral Infarction

Study ID

NCT06968663

Start date

Aug 1, 2024

Status verified date

Jun, 2026

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Right-handed

Exclusion Criteria:

  • 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
  • Epilepsy, or seizure after the stroke event
  • Pacemaker
  • Diagnosis of tinnitus
  • Pregnancy

Study Design

Enrollment

63 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Real TMS

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.

sham comparator: Fake TMS

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.

Interventions

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.

Modified Constraint Induced Language Therapy (mCILT)

Constraint-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.

Primary outcome measure

  • Overall language function [ Time Frame: From Baseline to 4 months post-interventions ]

Central Contacts and Locations

Central contacts

Leslie Vnenchak, MA, CCC-SLP

215-964-2502leslie.vnenchak@pennmedicine.upenn.edu

Daniela Sacchetti, MS

215-964-2502danielas@pennmedicine.upenn.edu

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19014

Contacts

Leslie Vnenchak, MA, CCC-SLP

215-964-2502leslie.vnenchak@pennmedicine.upenn.edu

Daniela Sacchetti, MS

215-964-2502danielas@pennmedicine.upenn.edu

Principal Investigator:

H. Branch Coslett, MD

More Information

Sponsor

University of Pennsylvania

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • aphasia
  • stroke
  • Transcranial Magnetic Stimulation
  • Non-invasive brain stimulation
  • language therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-06-18.