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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 belowSelect...
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:Select...
I have no history of brain injuries or neurological diseases.
Select...
I have not had a stroke affecting both sides of my brain or in the cerebellum or brainstem.
Select...
I can speak and understand well enough to participate in therapy.
Select...
I have never had a stroke in the right side of my brain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ compare baseline score to 6 month follow-up (after treatment) score.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~compare baseline score to 6 month follow-up (after treatment) score.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 21 and 80 years old.I have no history of brain injuries or neurological diseases.I have not had a stroke affecting both sides of my brain or in the cerebellum or brainstem.I can give my own consent or appoint someone to do it for me.I had a stroke in the left side of my brain over a year ago.I can speak and understand well enough to participate in therapy.I have never had a stroke in the right side of my brain.You should not have anything in your body that is not safe for a 3T MRI.I have been primarily speaking English for the last 20 years.You have trouble speaking clearly and understanding questions.
Research Study Groups:
This trial has the following groups:- Group 1: Aphasia Remote Therapy (ART)
- Group 2: In-Clinic Therapy (I-CT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.