NCT07608588

Brief Summary

This project aims to tailor repetitive Transcranial Magnetic Stimulation (rTMS) target to the clinical profile of post-stroke aphasia, specifically focusing on lexicosemantic impairments, to enhance recovery. Functional Magnetic Resonance Imaging (fMRI) will provide critical insights into the effects of facilitatory versus inhibitory stimulation on interhemispheric balance. Additionally, this study will generate new data on how lesion localization and brain connectivity influence individual responses to rTMS, explaining variability in treatment efficacy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
14mo left

Started May 2026

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
May 2026Jul 2027

First Submitted

Initial submission to the registry

April 22, 2026

Completed
23 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

May 29, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

April 22, 2026

Last Update Submit

May 26, 2026

Conditions

Keywords

aphasiastrokerTMSbrain stimulationspeech and language therapy

Outcome Measures

Primary Outcomes (1)

  • Picture Naming task accuracy

    The primary outcome is improvement in accuracy of the a Picture Naming task. Participants will complete a Picture Naming tasks based on the Older Adult Naming Test. Participants will name items from pictures as quickly and accurately as possible. Items will include mid-frequency words and 10 pictures of middle-to-late age-of-acquisition words (mean = 10.01 years, SD = 1.16).

    Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention

Secondary Outcomes (12)

  • Picture Naming Reaction time

    Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention

  • Auditory Description Naming accuracy

    Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention

  • Auditory Description Naming reaction time

    Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention

  • Comprehensive Aphasia Test - cognitive screening

    Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention

  • Comprehensive Aphasia Test - language score

    Baseline assessment conducted within 7 days prior to intervention Post-intervention assessment conducted within 3 days after the final intervention session Follow-up assessment conducted 1 month after the end of the intervention

  • +7 more secondary outcomes

Study Arms (3)

Inhibitory rTMS

EXPERIMENTAL

Participants will receive inhibitory continuous Theta Burst Stimulation (cTBS) targeting the right ATL 5 times a week for 2 weeks. Each stimulation session will be followed by 30-min of Speech and Language Therapy using the Semantic Feature Analysis protocol.

Device: continuous Theta Burst StimulationBehavioral: Semantic Feature Analysis

Facilitatory rTMS

EXPERIMENTAL

Participants will receive facilitatory intermittent Theta Burst Stimulation (iTBS) targeting the left ATL 5 times a week for 2 weeks. Each stimulation session will be followed by 30-min of Speech and Language Therapy using the Semantic Feature Analysis protocol.

Device: intermittent Theta Burst StimulationBehavioral: Semantic Feature Analysis

Sham rTMS

SHAM COMPARATOR

Participants will receive sham stimulation targeting either the left or right ATL with allocation balanced across participants, 5 times a week for 2 weeks. Each stimulation session will be followed by 30-min of Speech and Language Therapy using the Semantic Feature Analysis protocol.

Device: Transcranial Magnetic Stimulation ShamBehavioral: Semantic Feature Analysis

Interventions

We will use continuous Theta Burst Stimulation (600 pulses, burst frequency at 5 Hz, burst of three pulses at 50Hz) targeting the right ATL

Also known as: rTMS, repetitive Transcranial Magnetic Stimulation
Inhibitory rTMS

We will use intermittent Theta Burst Stimulation (600 pulses, burst frequency at 5 Hz, burst of three pulses at 50Hz, interval intertrain of 8 sec, 10 pulses in train) targeting the left ATL

Also known as: rTMS, repetitive Transcranial Magnetic Stimulation
Facilitatory rTMS

We will use sham stimulation using the same coil but flipped over, with the left ATL targeted in half of the participant and the right ATL in the other half. The placebo coil will replicate the auditory sensations produced by active stimulation. In addition, we will use electrical stimulation of the scalp (via electrodes placed over specific muscles) in the Sham group to mimic the sensory effects of active stimulation. Participants will have no prior rTMS experience before inclusion in the protocol.

Sham rTMS

Participants will receive 30 minutes of Semantic Feature Analysis therapy administered by a Speech and Language Pathologist. On a computer screen, participants will see an image of an object and will be cued to retrieve the object's name by describing various features of the object, including its physical properties, typical location, personal associations, category, use and actions involving the object (Quique et al., 2019).

Also known as: Speech and Language Therapy, SFA
Facilitatory rTMSInhibitory rTMSSham rTMS

Eligibility Criteria

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

You may qualify if:

  • Right-handedness (assesed using the Edinburgh Handedness Inventory)
  • Native English speakers
  • Single left hemispheric stroke
  • Diagnosis of aphasia and lexicosemantic impairments (e.g., anomia, semantic errors in picture naming or spontaneous speech) confirmed by a Speech and Language Pathologist or Physician

You may not qualify if:

  • Severely impaired auditory comprehension (WAB Comprehension score of 0 or 1)
  • Major phonological impairments (defined as \> 2 errors in non-word repetition of one- and two-syllable items on the PALPA, 2)
  • Contraindications to rTMS (e.g., uncontrolled epilepsy, history of seizures, intracranial ferromagnetic body, cochlear implant, or factors that lower seizure threshold (see Rossi et al., 2021)
  • Contraindication to MRI
  • Stroke involving the left ATL
  • Severe depression or psychiatric history
  • Illiteracy
  • Known neurodegenerative disorders
  • Severe uncorrected visual or hearing impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McCausland Center

Columbia, South Carolina, 29203, United States

RECRUITING

Related Publications (6)

  • Quique YM, Evans WS, Dickey MW. Acquisition and Generalization Responses in Aphasia Naming Treatment: A Meta-Analysis of Semantic Feature Analysis Outcomes. Am J Speech Lang Pathol. 2019 Mar 11;28(1S):230-246. doi: 10.1044/2018_AJSLP-17-0155.

    PMID: 30208415BACKGROUND
  • Arheix-Parras S, Barrios C, Python G, Cogne M, Sibon I, Engelhardt M, Dehail P, Cassoudesalle H, Moucheboeuf G, Glize B. A systematic review of repetitive transcranial magnetic stimulation in aphasia rehabilitation: Leads for future studies. Neurosci Biobehav Rev. 2021 Aug;127:212-241. doi: 10.1016/j.neubiorev.2021.04.008. Epub 2021 Apr 20.

    PMID: 33862065BACKGROUND
  • Hilari K, Byng S, Lamping DL, Smith SC. Stroke and Aphasia Quality of Life Scale-39 (SAQOL-39): evaluation of acceptability, reliability, and validity. Stroke. 2003 Aug;34(8):1944-50. doi: 10.1161/01.STR.0000081987.46660.ED. Epub 2003 Jul 10.

    PMID: 12855827BACKGROUND
  • Nippold MA, Mansfield TC, Billow JL. Peer conflict explanations in children, adolescents, and adults: examining the development of complex syntax. Am J Speech Lang Pathol. 2007 May;16(2):179-88. doi: 10.1044/1058-0360(2007/022).

    PMID: 17456896BACKGROUND
  • Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.

    PMID: 33243615BACKGROUND
  • Arheix-Parras S, Moore SR, Desai RH. Improving Lexicosemantic Impairments in Post-Stroke Aphasia Using rTMS Targeting the Right Anterior Temporal Lobe. Brain Sci. 2026 Jan 22;16(1):117. doi: 10.3390/brainsci16010117.

    PMID: 41594838BACKGROUND

MeSH Terms

Conditions

StrokeAphasiaCommunication Disorders

Interventions

Transcranial Magnetic StimulationSpeech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpeech DisordersLanguage DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Sophie Arheix-Parras, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: We will conduct a superiority randomized controlled trial. Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) inhibitory continuous Theta Burst Stimulation (cTBS) targeting the right ATL; (2) the facilitatory intermittent Theta Burst Stimulation (iTBS) targeting the left ATL; (3) sham stimulation, targeting either the left or right ATL with allocation balanced across participants. In all three groups, participants will receive rTMS five times per week for two consecutive weeks (10 sessions in total). Each rTMS session will be immediately followed by Speech and Language Therapy (SLT) using the Semantic Feature Analysis (SFA) protocol. Assessments will be conducted at baseline, immediately post-intervention, and at one-month follow-up. Participants will also undergo fMRI scanning at S1 and S2.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

April 22, 2026

First Posted

May 27, 2026

Study Start

May 15, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

May 29, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The expected data types include: * Behavioral data: Accuracy and reaction times measures for cognitive and language tasks. * Neuroimaging data: Structural MRI (T1 and T2 weighted) and functional MRI (resting state and task-based, for around 15 minutes per session)

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be made available upon publication of the respective study. Data will remain accessible for at least 10 years post-publication.
Access Criteria
Interested research will be able to access the following data : - De-identified behavioral data (reaction time, accuracy, transcription) at be shared publicly using OSF * Audio recordings will not be shared due to confidentiality risks * Neuroimaging data (structural and functional MRI) will be shared after de-identification (face removal) in OpenNeuro * Aggregate results will be disseminated via peer-reviewed publications and conference presentations. * Study protocol, task descriptions, and analysis pipelines will be documented in manuscripts * Metadata describing participant demographics (e.g., age, gender, stroke type, lesion location) will be included in shared dataset and available in manuscripts * Documentation will be provided upon request to facilitate data interpretation

Locations