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Trial record 19 of 2327 for:    brain injury

Narrative Comprehension by People With Acquired Brain Injury

This study is currently recruiting participants.
Verified October 2017 by Kelly Knollman-Porter, Miami University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03309930
First Posted: October 16, 2017
Last Update Posted: October 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Duquesne University
University of Nebraska Lincoln
University of Arizona
Information provided by (Responsible Party):
Kelly Knollman-Porter, Miami University
  Purpose
The purpose of this two phase study is to evaluate comprehension by people with acquired brain injury. The phase 1 portion of the study will examine comprehension of narrative paragraphs under 3 conditions: (a) written text only, (b) auditory output only (i.e., synthetic speech - David voice) or combined written text and auditory output. The phase 2 portion of the study is to evaluate comprehension of sentences and paragraphs produced with computer generated (synthesized) speech and digitized natural speech after multiple exposures.

Condition Intervention
Aphasia Traumatic Brain Injury Behavioral: Comprehension Acquired Brain Injury

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
During Study 1 participants will be exposed to three different conditions: (a) written text only, (b) auditory synthetic speech output only and (c) a combined condition (written and auditory output). During Study 2 participants will be provided repeated exposure to synthetic speech. Participants can participate in 1 or both studies with 1 study results not being dependent on the other study. .
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Narrative Comprehension by People With Acquired Brain Injury

Further study details as provided by Kelly Knollman-Porter, Miami University:

Primary Outcome Measures:
  • Comprehension Across Conditions (Study 1 of 2) [ Time Frame: Comprehension accuracy across conditions will be assessed over 1 to 2 days. ]
    Participants will answer 10 multiple choice questions regarding the information contained in each of the 12 stories presented in 3 conditions: (1) written text only (b) auditory output only and (c) combined written text and auditory output .

  • Repeated Exposure to Digitized and Synthetic Speech (Study 2 of 2) [ Time Frame: 2 weeks ]
    Participants will answer 30 yes/no questions per session. Comprehension percentage accuracy will be measured over the course of 2 weeks


Secondary Outcome Measures:
  • Comprehension Generalization [ Time Frame: measured 1 week and 4 weeks post termination of treatment ]
    Participants will listen to two stories presented in synthetic, computer generated speech and answer comprehension questions about the content of the stories to determine auditory comprehension accuracy

  • Perceived Comprehension Accuracy [ Time Frame: measured 1 week and 4 weeks post termination of treatment ]
    Participants will rate the accuracy and ease of comprehension of the sentences from each condition using a 5 point Likert scale.


Estimated Enrollment: 60
Actual Study Start Date: October 6, 2017
Estimated Study Completion Date: October 6, 2018
Estimated Primary Completion Date: October 6, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Comprehension Acquired Brain Injury
All participants will be exposed to 3 conditions: (a) written text, (b) auditory output (synthetic speech), and combined conditions for study 1. For study 2 participants will be repeatedly exposed to synthetic speech output to determine the influence on comprehension. Participants are not required to participate in both studies.
Behavioral: Comprehension Acquired Brain Injury
For study 1 participants will be exposed to 3 conditions as stated in previous descriptions and will last 1 to 2 sessions. Study 2 will begin with 1 session with the researcher lasting about 30 minutes. Then participants will be asked to complete practice at home for about 15 minutes each day for 2 weeks using a computer/iPad. Study 2 Post Testing and Maintenance Sessions 1 and 2: approximately 60 minutes per session.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • have a clinical diagnosis of an acquired cognitive-communication impairment secondary to brain injury/stroke
  • be 19-85 years of age
  • be a least, 3 months post acquired brain injury
  • primarily be a speaker of American English

Exclusion Criteria:

  • exhibit the presence of a hearing impairment (i.e., prescribed hearing aid or failed hearing screening)
  • demonstrate a vision or motor impairment that negatively influences study completion
  • Study 2: have not access to wireless internet
  • Study 2: exhibit and inability to independently (or with caregiver support) use the iPad device to complete the experimental tasks.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309930


Contacts
Contact: Kelly K Knollman-Porter, PhD 7652653640 knollmkk@miamioh.edu
Contact: Sarah Wallace, PhD 4123964219 wallaces@duq.edu

Locations
United States, Ohio
Miami University Recruiting
Oxford, Ohio, United States, 45056
Contact: Kelly K Knollman-Porter, PhD    765-265-3640    knollmkk@miamioh.edu   
Contact: Susan Brehm, PhD    513-529-2553    bakerse1@miamioh.edu   
Sponsors and Collaborators
Miami University
Duquesne University
University of Nebraska Lincoln
University of Arizona
Investigators
Principal Investigator: Kelly K Knollman-Porter, PhD Miami University
Principal Investigator: Sarah Wallace, PhD Duquesne University
  More Information

Publications:
Wagner R. K., Torgesen J. K., Rashotte C. A., Pearson N. A. (2010). Test of Silent Reading Efficiency and Comprehension (TOSREC) examiner's manual. Austin, TX: Pro-Ed.

Responsible Party: Kelly Knollman-Porter, Assistant Professor, Miami University
ClinicalTrials.gov Identifier: NCT03309930     History of Changes
Other Study ID Numbers: #01377r
First Submitted: October 9, 2017
First Posted: October 16, 2017
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing the data because of possible breach of privacy given the small number of local people with acquired brain injury/stroke.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kelly Knollman-Porter, Miami University:
comprehension
Strategies
repeated exposure

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Aphasia
Central Nervous System Diseases
Nervous System Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms