NCT06968663

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:

  • 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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for phase_2 stroke

Timeline
39mo left

Started Apr 2025

Longer than P75 for phase_2 stroke

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 Progress28%
Apr 2025Jul 2029

Study Start

First participant enrolled

April 8, 2025

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

May 5, 2025

Last Update Submit

April 28, 2026

Conditions

StrokeAphasiaAphasia Following Cerebral Infarction

Keywords

aphasiastrokeTranscranial Magnetic StimulationNon-invasive brain stimulationlanguage therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    From Baseline to 4 months post-interventions

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 language therapy.

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.

Behavioral: Modified Constraint Induced Language Therapy (mCILT)

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
Modified Constraint Induced Language Therapy (mCILT)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 TMSReal TMS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

RECRUITING

MeSH Terms

Conditions

StrokeAphasia

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • H. Branch Coslett, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leslie Vnenchak, MA, CCC-SLP

CONTACT

215-964-2502leslie.vnenchak@pennmedicine.upenn.edu

Daniela Sacchetti, MS

CONTACT

215-964-2502danielas@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

May 5, 2025

First Posted

May 13, 2025

Study Start

April 8, 2025

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

July 31, 2029

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations

US(1)