AphasiaPhase 2TMSNCT06842745
Transcranial Magnetic Stimulation + Language Therapy to Treat Mild Aphasia
A Phase 2 study testing Transcranial Magnetic Stimulation (TMS) and Speech-Language Therapy (SLT) in people with Aphasia and Stroke, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Aphasia, Stroke, Aphasia Following Cerebral Infarction
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) and Speech-Language Therapy (SLT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2025to 31 Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Left Hemisphere stroke
- Stroke occurred more than 6 months ago
- Mild Aphasia (WAB AQ score > 85)
- Proficient in English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daniela Sacchetti, MS contact
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19014
About this study
Official title: Personalized Transcranial Magnetic Stimulation and Constraint Induced Language Therapy to Treat Mild Post-Stroke Aphasia
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:
Read more
- Can TMS combined with SLT improve conversational speech and comprehension?
- 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
Read the 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.
- Being tested
- Transcranial Magnetic Stimulation (TMS), Speech-Language Therapy (SLT)
- Keywords
- aphasia, stroke, non-invasive brain stimulation, Transcranial Magnetic Stimulation
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Real TMS | Experimental | 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. Receives: Device: Transcranial Magnetic Stimulation (TMS); Behavioral: Speech-Language Therapy (SLT) |
| Fake TMS | Sham comparator | 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. Receives: Behavioral: Speech-Language Therapy (SLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentence Processing
Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score.
Measured: From baseline to 4 months post-intervention
Secondary outcomes (2)
Semantic and Phonological Processing
Change in performance on the TALSA composite semantic processing score and phonological processing score.
Measured: From baseline to 4 months post-intervention
Elicited Speech
Change in performance on the Nicholas \& Brookshire picture description and Story Retell scores.
Measured: From baseline to 4 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start11 Feb 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- H. Branch Coslett, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842745
- Sponsor's protocol ID
- 857363
- Other IDs
- 1R21DC021833-01
- Acronym
- TMS
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, the study team does not plan to share participating data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Transcranial Magnetic Stimulation and Constraint Induced Language Therapy to Treat Mild Post-Stroke Aphasia
- ClinicalTrials.gov ID
- NCT06842745
- Acronym / sponsor ID
- TMS / 857363
- Keywords
- aphasia, stroke, non-invasive brain stimulation, Transcranial Magnetic Stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Temple University, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 11 Feb 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can TMS combined with SLT improve conversational speech and comprehension?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real TMS | Experimental | Device: Transcranial Magnetic Stimulation (TMS), Behavioral: Speech-Language Therapy (SLT)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. |
| Fake TMS | Sham comparator | Behavioral: Speech-Language Therapy (SLT)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. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Left Hemisphere stroke
- Stroke occurred more than 6 months ago
- Mild Aphasia (WAB AQ score > 85)
- Proficient in English
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Real TMS |
| 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. | Behavioural | Fake TMS, Real TMS |
Primary outcome
Sentence Processing
Time frame: From baseline to 4 months post-intervention
Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score.
2 secondary outcomes
Semantic and Phonological Processing
Time frame: From baseline to 4 months post-intervention
Elicited Speech
Time frame: From baseline to 4 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. No, the study team does not plan to share participating data at this time.
Related trials for Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniela Sacchetti, MS contact
H. Branch Coslett, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transcranial Magnetic Stimulation (TMS) and Speech-Language Therapy (SLT) in people with Aphasia and Stroke, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harris Drachman, MS (215-964-2502, harris.drachman@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentence Processing (time frame: From baseline to 4 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.