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Speech-Language Therapy for Aphasia (TERRA Trial)

N/A
Recruiting
Led By Julius Fridriksson, Ph.D.
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be between 21-80 years of age.
Participants must primarily speak English for at least the past 20 years.
Must not have
Participants must not have previous neurological disease affecting the brain (e.g. history of traumatic brain injury).
Participants must not have a bilateral, cerebellar or brainstem stroke.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up compare baseline score to 6 month follow-up (after treatment) score.
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the efficacy of two types of speech-language therapy for patients with aphasia.

Who is the study for?
This trial is for English-speaking adults aged 21-80 who've had a left hemisphere stroke at least a year ago and can consent to treatment. They must be MRI compatible without metal implants or claustrophobia, and have no history of other brain diseases or severe speech/comprehension impairments.
What is being tested?
The TERRA study compares two types of speech-language therapy for aphasia after a stroke: one delivered remotely (ART) and the other in-clinic (I-CT). It aims to see if telerehabilitation is as effective as traditional methods.
What are the potential side effects?
Since this trial involves non-invasive therapies focused on language rehabilitation, significant side effects are not anticipated. However, participants may experience fatigue or frustration during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 80 years old.
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I have been primarily speaking English for the last 20 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have no history of brain injuries or neurological diseases.
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I have not had a stroke affecting both sides of my brain or in the cerebellum or brainstem.
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I can speak and understand well enough to participate in therapy.
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I have never had a stroke in the right side of my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare baseline score to 6 month follow-up (after treatment) score.
This trial's timeline: 3 weeks for screening, Varies for treatment, and compare baseline score to 6 month follow-up (after treatment) score. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Speech Production Outcome Score (SPOTS)
Secondary study objectives
Improvement in overall aphasia severity
Improvement in quality of life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Aphasia Remote Therapy (ART)Experimental Treatment2 Interventions
All participants in this group will receive 3 weeks of daily semantically-focused treatment (semantic feature analysis, semantic barrier task and verb network strengthening therapy) and 3 weeks of daily phonologically-focused treatment (phonological components analysis, phonological production task, phonological judgment task). Participants will be randomized to order of treatment. All treatment will be done remotely with a speech-language pathologist through an online platform using therapy applications. Participants will be provided with teletherapy kits (including an Internet hotspot if needed) to complete the therapy tasks.
Group II: In-Clinic Therapy (I-CT)Active Control2 Interventions
All participants in this group will receive 3 weeks of daily semantically-focused treatment (semantic feature analysis, semantic barrier task and verb network strengthening therapy) and 3 weeks of daily phonologically-focused treatment (phonological components analysis, phonological production task, phonological judgment task). Participants will be randomized to order of treatment. All treatment will be done in person with a speech-language pathologist at the UofSC Aphasia Lab.

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor
223 Previous Clinical Trials
119,130 Total Patients Enrolled
6 Trials studying Aphasia
521 Patients Enrolled for Aphasia
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
361 Previous Clinical Trials
182,197 Total Patients Enrolled
39 Trials studying Aphasia
2,724 Patients Enrolled for Aphasia
Medical University of South CarolinaOTHER
978 Previous Clinical Trials
7,400,829 Total Patients Enrolled
5 Trials studying Aphasia
327 Patients Enrolled for Aphasia
Julius Fridriksson, Ph.D.Principal Investigator - University of South Carolina
University of South Carolina

Media Library

Phonologically-focused therapy tasks Clinical Trial Eligibility Overview. Trial Name: NCT04682223 — N/A
Aphasia Research Study Groups: Aphasia Remote Therapy (ART), In-Clinic Therapy (I-CT)
Aphasia Clinical Trial 2023: Phonologically-focused therapy tasks Highlights & Side Effects. Trial Name: NCT04682223 — N/A
Phonologically-focused therapy tasks 2023 Treatment Timeline for Medical Study. Trial Name: NCT04682223 — N/A
~22 spots leftby Jan 2026