Effects of Recursive Self-feedback on Speech Production in Aphasia

Recursive Self-feedback Procedures for Improving Spontaneous Speech Production in Patients With Chronic Aphasia

The goal of this clinical trial is to test the effects of recursive self-feedback procedures on spontaneous speech production in stroke survivors with impaired speech production (aphasia). The main question it aims to answer is:

• To what extent can stroke survivors with aphasia use their self-feedback alone to improve their spontaneous speech production?

Participants will be engaged in the following activities:

• They will perform language and cognitive tasks.
• Afterwards, they will receive treatments using tablets and headphones at no cost to them.
• The experimental treatments (recursive self-feedback procedures) entails responding to prompts, listening to playbacks of their speech response and attempt to minimize/correct the errors in the next attempt. This process will be repeated multiple times per prompt.
• The experimental treatments are two: an adaptive version that adapts the complexity of the treatment prompt and a non-adaptive version that does not adapt task complexity.
• Researchers will compare the experimental treatments to see if both have similar effects on improving spontaneous speech production.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Aphasia
• Intervention / Treatment: Behavioral: Adaptive recursive self-feedback procedure; Behavioral: Non-adaptive recursive self-feedback procedure

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerald C. Imaezue, PhD; Phone Number: (813)974-2464; Email: gimaezue@usf.com
• Study Contact Backup: Name: William Burgin, MD; Phone Number: 813-259-8577; Email: wburgin@usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 6 months post left hemisphere stroke
• Aphasia due to left hemisphere stroke
• Dominant English speaker

Exclusion Criteria:

• Speech-language deficits due to neurological insults such as Parkinson's disease, neurodegenerative conditions etc.
• Uncorrected sensory impairments.
• Language comprehension impairment.
• Severe cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adaptive recursive self-feedback procedure; Using a tablet, participants listen to speech playback of their response to a prompt and self-correct/minimize their speech errors in a subsequent attempt. This process is looped multiple times per prompt. It adapts across narrative prompts with low and high complexities.	Behavioral: Adaptive recursive self-feedback procedure; The intervention uses self-feedback alone to improve speech production. It adapts the complexity of the treatment tasks.
Experimental: Non-adaptive recursive self-feedback procedure; Using a tablet, participants listen to speech playback of their response to a prompt and self-correct/minimize their speech errors in a subsequent attempt. This process is looped multiple times per prompt. However, it only uses narrative prompts with high complexity.	Behavioral: Non-adaptive recursive self-feedback procedure; The intervention uses self-feedback alone to improve speech production. However, it does not adapt the complexity of the treatment tasks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Speaking rate	Correct words produced per minute	Within 1 week before treatment and within 1 week after treatment.
Speech initiation latency in milliseconds	Latency before retrieving the first correct word in an utterance.	Within 1 week before treatment and within 1 week after treatment.

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Center for Smart Use of Technologies to Assess Real-world Outcomes
• Investigators: Principal Investigator: Gerald C. Imaezue, PhD, University of South Florida

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: STUDY006201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will only be shared with approved members of the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No