StrokePhase 2NCT06968663
Transcranial Magnetic Stimulation + Language Therapy to Treat Subacute Aphasia
A Phase 2 study testing Transcranial Magnetic Stimulation (TMS) and Modified Constraint Induced Language Therapy (mCILT) in people with Stroke and Aphasia, 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 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Aphasia, Aphasia Following Cerebral Infarction
- What is being tested?
- Transcranial Magnetic Stimulation (TMS) and Modified Constraint Induced Language Therapy (mCILT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Jul 2029
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19014
Leslie Vnenchak, MA, CCC-SLP, 215-964-2502, leslie.vnenchak@pennmedicine.upenn.edu
Daniela Sacchetti, MS, 215-964-2502, danielas@pennmedicine.upenn.edu
About this study
Official title: Electrical Field Guided Transcranial Magnetic Stimulation to Treat Subacute Post-stroke Aphasia
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:
Read more
- Can TMS combined with mCILT improve overall speech?
- 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
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.
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
- Being tested
- Transcranial Magnetic Stimulation (TMS), Modified Constraint Induced Language Therapy (mCILT)
- Keywords
- aphasia, stroke, Transcranial Magnetic Stimulation, Non-invasive brain stimulation, language therapy
- Medical subject headings
- Stroke, Aphasia
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.
Modified Constraint Induced Language Therapy (mCILT)Behavioural
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.
| 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 language therapy. Receives: Device: Transcranial Magnetic Stimulation (TMS); Behavioral: Modified Constraint Induced Language Therapy (mCILT) |
| 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 language therapy. Receives: Behavioral: Modified Constraint Induced Language Therapy (mCILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall language function
Change in performance on the Western Aphasia Battery (WAB-AQ score). WAB AQ Score is out of 100, where a higher score means less language impairment.
Measured: From Baseline to 4 months post-interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Aug 2024
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H. Branch Coslett, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968663
- Sponsor's protocol ID
- 856766
- Status last verified
- Jun 2026
- First submitted
- 5 May 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Field Guided Transcranial Magnetic Stimulation to Treat Subacute Post-stroke Aphasia
- ClinicalTrials.gov ID
- NCT06968663
- Acronym / sponsor ID
- 856766
- Conditions
- Stroke, Aphasia, Aphasia Following Cerebral Infarction
- Keywords
- aphasia, stroke, Transcranial Magnetic Stimulation, Non-invasive brain stimulation, language therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 13 May 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 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:
- Can TMS combined with mCILT improve overall speech?
- 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.
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: Modified Constraint Induced Language Therapy (mCILT)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. |
| Fake TMS | Sham comparator | Behavioral: Modified Constraint Induced Language Therapy (mCILT)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 may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
| 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. | Behavioural | Fake TMS, Real TMS |
Primary outcome
Overall language function
Time frame: From Baseline to 4 months post-interventions
Change in performance on the Western Aphasia Battery (WAB-AQ score). WAB AQ Score is out of 100, where a higher score means less language impairment.
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 18 Jun 2026.
- Individual participant dataSharing planned: No. No, the study team does not plan to share participating data at this time.
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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.
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 Modified Constraint Induced Language Therapy (mCILT) in people with Stroke and Aphasia, 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 5 inclusion and 8 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 18 Jun 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 Leslie Vnenchak, MA, CCC-SLP (215-964-2502, leslie.vnenchak@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall language function (time frame: From Baseline to 4 months post-interventions). 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 18 Jun 2026.