Recovery From Post-Stroke Aphasia With rTMS Targeting Left or Right Anterior Temporal Lobe

ConditionsStrokeAphasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • continuous Theta Burst Stimulation

    Device

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

  • intermittent Theta Burst Stimulation

    Device

    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

  • Transcranial Magnetic Stimulation Sham

    Device

    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.

  • Semantic Feature Analysis

    Behavioral

    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).

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Inhibitory rTMSExperimental treatment 2 interventions
Group B: Facilitatory rTMSExperimental treatment 2 interventions
Group C: Sham rTMSSham comparator 2 interventions

Trial outcomes

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).

Time frame
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

1

Picture Naming Reaction time

Reaction times will also be recorded for the picture naming task using E-Prime software (version 3.0). A decrease in reaction time for the picture naming task will be considered as an improvement.

Time frame
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
2

Auditory Description Naming accuracy

Participants will complete an Auditory Description Naming based on the Older Adult Naming Test. Participants will name items from verbal descriptions as quickly and accurately as possible. Items will include mid-frequency words supplemented with 10 descriptions of middle to high-frequency abstract words (mean frequency = 3.45, SD = 0.90).

Time frame
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
3

Auditory Description Naming reaction time

Reaction times will also be recorded using E-Prime software (version 3.0) for the auditory description naming task. A decrease in Reaction Time will be considered as improvement.

Time frame
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
4

Comprehensive Aphasia Test - cognitive screening

Online version of the Comprehensive Aphasia Test (CAT): cognitive screening score (scale /49, higher meaning better outcome)

Time frame
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

Other outcomes

Sponsors and contacts

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University of South Carolina

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator