Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia

NCT ID: NCT06968663

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2029-07-31

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

Detailed Description

Aphasia is an acquired disorder of language that occurs in approximately 30% of individuals with stroke and impacts approximately 1 million Americans (see NINDS.NIH.gov). Current treatments for aphasia are only modestly beneficial, so there is a clear need for more efficacious therapy.

Most studies of TMS as a therapy for aphasia have investigated treatment in the chronic phase after stroke (>6 months post-stroke). Previous research has demonstrated that TMS improves language performance in persons with chronic aphasia and the benefit has been shown to be sustained. Several lines of evidence, however, suggest that TMS treatment in the subacute period may be more effective than interventions in the chronic stage.

One limitation of TMS has been variability in response; TMS has shown good within-subject reliability but more substantial variability between subjects. In recognition of these issues, "electrical field" (e-field) models have been developed to account for these individual differences in anatomy. We will the utilize e-field models in conjunction with an individually determined resting motor threshold to generate a personalized treatment regimen that is likely to ensure that all subjects receive the same TMS intensity relative to their individual motor threshold and greatly reduces the possibility of under- or over-dosing with respect to TMS intensity. We will employ continuous theta-burst stimulation, 600 brief electrical pulses delivered in 40 seconds, over the right front part of the brain (pars triangularis).

Participants who are enrolled can expect to undergo a battery of tests to define their language function as well as a research MRI scan that will be used to guide TMS therapy and to assess the size and location of the stroke and its impact on brain pathways. After baseline testing, subjects will undergo treatment using TMS (or sham) + mCILT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately and 4 months after treatment.

Participants will be compensated for their time and travel.

Conditions

Stroke; Aphasia; Aphasia Following Cerebral Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type: 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.

Modified Constraint Induced Language Therapy (mCILT)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: SHAM_COMPARATOR

Modified Constraint Induced Language Therapy (mCILT)

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

H. Branch Coslett, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Leslie Vnenchak, MA, CCC-SLP

Role: CONTACT

leslie.vnenchak@pennmedicine.upenn.edu

215-964-2502

Daniela Sacchetti, MS

Role: CONTACT

danielas@pennmedicine.upenn.edu

215-964-2502

Facility Contacts

Leslie Vnenchak, MA, CCC-SLP

Role: primary

leslie.vnenchak@pennmedicine.upenn.edu

215-964-2502

Daniela Sacchetti, MS

Role: backup

danielas@pennmedicine.upenn.edu

215-964-2502

Other Identifiers

856766

Identifier Type: -

Identifier Source: org_study_id