Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia

NCT ID: NCT06842745

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2026-08-31

Brief Summary

The goal of this clinical trial is to determine if Transcranial Magnetic Stimulation (TMS) combined with Speech-Language Therapy (SLT) is an effective treatment for mild aphasia in persons with chronic stroke.

The main questions this study aims to answer are:

1. Can TMS combined with SLT improve conversational speech and comprehension?

2. Can we identify specific behavioral and biological characteristics that would benefit most from the TMS and SLT treatment?

Researchers will compare real TMS to sham (fake) TMS to see whether TMS can treat post-stroke mild aphasia.

Participants will:

• Complete a screening and medical intake to determine eligibility
• Undergo a MRI
• Participate in 10 consecutive sessions (Monday-Friday) of TMS and SLT treatment
• Complete follow-up assessments 2 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.

Previous research has demonstrated that TMS improves language performance in persons with aphasia and the benefit has been shown to be sustained. All studies of which we are aware, however, have included participants with moderate/severe aphasia. The issue of mild aphasia has received little attention to date but as there is an increasing recognition that even very mild language deficits have important negative consequences for employment and social well-being. This study will aim to treat mild aphasia with TMS and SLT emphasizing conversations speech.

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) + SLT for 10 sessions (Monday-Friday) over the course of 2 consecutives week. Follow-up assessment of language functioning will be assessed immediately, 2 months and 4 months after treatment.

Participants will be compensated for their time and travel.

Conditions

Aphasia; Stroke; Aphasia Following Cerebral Infarction; Aphasia, Acquired

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 speech-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.

Speech-Language Therapy (SLT)

Intervention Type: BEHAVIORAL

Our SLT protocol draws from two theories and evidence-based cognitive-linguistic frameworks: (1) conversational alignment, which engages priming of lexical and syntactic structures through dialogue and conversation and (2) increased tolerance of memory load in the context of sentence repetition and dialogue tasks. Administration of these tasks will abide by principles of constraint-induced language therapy, i.e., intense treatment schedule and verbal responding only.

All participants will receive SLT.

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 speech-language therapy.

Group Type: SHAM_COMPARATOR

Speech-Language Therapy (SLT)

Intervention Type: BEHAVIORAL

Our SLT protocol draws from two theories and evidence-based cognitive-linguistic frameworks: (1) conversational alignment, which engages priming of lexical and syntactic structures through dialogue and conversation and (2) increased tolerance of memory load in the context of sentence repetition and dialogue tasks. Administration of these tasks will abide by principles of constraint-induced language therapy, i.e., intense treatment schedule and verbal responding only.

All participants will receive SLT.

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

Speech-Language Therapy (SLT)

Our SLT protocol draws from two theories and evidence-based cognitive-linguistic frameworks: (1) conversational alignment, which engages priming of lexical and syntactic structures through dialogue and conversation and (2) increased tolerance of memory load in the context of sentence repetition and dialogue tasks. Administration of these tasks will abide by principles of constraint-induced language therapy, i.e., intense treatment schedule and verbal responding only.

All participants will receive SLT.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Left Hemisphere stroke
• Stroke occurred more than 6 months ago
• Mild Aphasia (WAB AQ score > 85)
• Proficient in English

Exclusion Criteria

• Ongoing substance or alcohol abuse
• Other neurological disorders, beside stroke (i.e. dementia, traumatic brain injury, multiple sclerosis)
• Active psychiatric disorders (i.e. bipolar disorder, schizophrenia)
• Pacemaker or cardiac defibrillator
• Diagnosis of tinnitus
• Epilepsy, or seizure in the past 6 months

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Temple University

OTHER

Sponsor Role: collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

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

Harris Drachman, MS

Role: CONTACT

harris.drachman@pennmedicine.upenn.edu

215-964-2502

Daniela Sacchetti, MS

Role: CONTACT

danielas@pennmedicine.upenn.edu

Other Identifiers

1R21DC021833-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

857363

Identifier Type: -

Identifier Source: org_study_id