NCT06323629

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 21, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

February 21, 2024

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (2)

Adaptive recursive self-feedback procedure

EXPERIMENTAL

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

Non-adaptive recursive self-feedback procedure

EXPERIMENTAL

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

Interventions

The intervention uses self-feedback alone to improve speech production. It adapts the complexity of the treatment tasks.

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.

Non-adaptive recursive self-feedback procedure

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AphasiaStroke

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Gerald C. Imaezue, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerald C. Imaezue, PhD

CONTACT

William Burgin, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2024

First Posted

March 21, 2024

Study Start

April 1, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will only be shared with approved members of the research team.