Recruiting

rTMS

Sponsor:

University of South Carolina

Code:

NCT07608588

Conditions

Stroke

Aphasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

continuous Theta Burst Stimulation

intermittent Theta Burst Stimulation

Transcranial Magnetic Stimulation Sham

Semantic Feature Analysis

Study Details

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.

Conditions

Stroke

Aphasia

Study ID

NCT07608588

Start date

May 15, 2026

Status verified date

May, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Inhibitory rTMS

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.

experimental: Facilitatory rTMS

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.

sham comparator: Sham rTMS

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.

Interventions

continuous Theta Burst Stimulation

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

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

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

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).

Primary outcome measure

  • Picture Naming task accuracy [ 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 ]

Central Contacts and Locations

Central contacts

Locations

McCausland Center

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Principal Investigator:

Sophie Arheix-Parras, PhD

More Information

Sponsor

University of South Carolina

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • aphasia
  • stroke
  • rTMS
  • brain stimulation
  • speech and language therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2026-05-29.