NCT06842745

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:

  • 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
4mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Feb 2025Aug 2026

Study Start

First participant enrolled

February 11, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

February 18, 2025

Last Update Submit

March 4, 2026

Conditions

AphasiaStrokeAphasia Following Cerebral InfarctionAphasia, Acquired

Keywords

aphasiastrokenon-invasive brain stimulationTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Sentence Processing

    Change in performance on the Temple Assessment of Language and Short-term Memory in Aphasia (TALSA) sentence processing composite score.

    From baseline to 4 months post-intervention

Secondary Outcomes (2)

  • Semantic and Phonological Processing

    From baseline to 4 months post-intervention

  • Elicited Speech

    From baseline to 4 months post-intervention

Study Arms (2)

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.

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.

Behavioral: Speech-Language Therapy (SLT)

Interventions

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.

Real TMS
Speech-Language Therapy (SLT)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 TMSReal TMS

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

RECRUITING

MeSH Terms

Conditions

AphasiaStroke

Interventions

Transcranial Magnetic StimulationSpeech Therapy

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeuticsRehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient Care

Study Officials

  • H. Branch Coslett, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harris Drachman, MS

CONTACT

215-964-2502harris.drachman@pennmedicine.upenn.edu

Daniela Sacchetti, MS

CONTACT

danielas@pennmedicine.upenn.edu

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2025

First Posted

February 24, 2025

Study Start

February 11, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

No, the study team does not plan to share participating data at this time.

Locations

US(1)