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Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia (START)

Primary Purpose

Stroke, Aphasia, Apraxia of Speech

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Startle Adjuvant Rehabilitation Therapy (START)
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years old
  • Native English Speakers
  • Capacity to provide informed consent
  • Right-handed
  • Corrected to normal vision
  • Left hemisphere cerebral stroke at least 6 months prior to testing
  • Presence of severe-to-moderate, non-fluent aphasia, i.e. Aphasia Quotients of 0-50 on the Western Aphasia Battery-Revised (PsychCorp, 2007)
  • Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender41,42 NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. Based on our ongoing aphasia studies, we expect that ~30% of participants will use hearing aids; we will not exclude these individuals but rather include hearing aid use as a covariate in analyses.

Exclusion Criteria:

  • Severe concurrent uncontrolled medical problems (e.g. cardiorespiratory impairment).

Sites / Locations

  • Arizona State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

START

Control

Arm Description

START (startle adjuvant rehabilitation therapy) will be applied.

Subjects will train but without START

Outcomes

Primary Outcome Measures

Western Aphasia Battery
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Western Aphasia Battery Retention
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Apraxia Battery for adults
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Apraxia Battery for adults Retention
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Stroke Impact Scale
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Stroke Impact Scale Retention
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.

Secondary Outcome Measures

Full Information

First Posted
March 23, 2021
Last Updated
February 19, 2022
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT04816799
Brief Title
Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia
Acronym
START
Official Title
Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

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

5. Study Description

Brief Summary
A stratified, parallel-group, double-blind, randomized controlled trial of remotely delivered START treatment to individuals with severe-to-moderate stroke (with recruitment focused on individuals with low SES) will be conducted. Subjects and assessors will be blinded to the condition making the experiment double blind. Specifically, subjects will be told that we are exploring a new therapy that using different sounds to improve therapy. Parallel group design will ensure that subjects in the Control group are unaware that their "sounds" are softer than the START group. Trainers may become aware that a loud sound is present thus a unique Assessor will evaluate clinical performance before and after training making the study double-blind. Fifty-four subjects will undergo baseline testing in the laboratory to establish their capacity for functional and expressive speech as well as their self-reported health-related quality of life (power analysis below). Next, subjects will participate in a high-frequency, word-picture verification/ auditory-repetition treatment, 2 hr/day for 5 consecutive days focusing on expression of words of functional significance (e.g., water, fall). Subjects will either receive training with START or without (Control). Subjects will be re-tested immediately following training as well as one-month post to assess retention. Aim 1 will evaluate capacity of START to enhance SLT outcomes by assessing the % change in clinical assessment of functional and expressive speech. Our preliminary data points to a robust response [details]. Aim 2 will focus on the capacity of these changes to 1) be retained and 2) impact subject's reported quality of life. NOTE: While we are planning in-person baseline, end, and retention testing, in response to COVID, we have established remote clinical screening using peer-reviewed validated techniques for WAB and ABA-2 (see Alternative Solutions). All preliminary data collected for this proposal were collected remotely via no-contact protocols.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia, Apraxia of Speech

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
START
Arm Type
Experimental
Arm Description
START (startle adjuvant rehabilitation therapy) will be applied.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will train but without START
Intervention Type
Behavioral
Intervention Name(s)
Startle Adjuvant Rehabilitation Therapy (START)
Intervention Description
Exposure to loud acoustic stimulus during training of motor task (in this case speech).
Primary Outcome Measure Information:
Title
Western Aphasia Battery
Description
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Time Frame
end of training
Title
Western Aphasia Battery Retention
Description
(WAB) will be administered to determine aphasia severity via its aphasia quotient, as well as aphasia type. Severe non-fluent aphasia will be defined as an aphasia quotient < 50 and a classification of Broca's, global, or transcortical motor aphasia.
Time Frame
one month post
Title
Apraxia Battery for adults
Description
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Time Frame
end of training
Title
Apraxia Battery for adults Retention
Description
(ABA-2) will be collected to identify presence and severity of apraxia of speech (AOS) via its six subtests: diadochokinetic rate, increasing word length, limb and oral apraxia, and latency and utterance for polysyllabic words, repeated trials, and inventory of articulation characteristics.
Time Frame
one-month post
Title
Stroke Impact Scale
Description
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Time Frame
Baseline, end of training, one-month post
Title
Stroke Impact Scale Retention
Description
(SIS) is a self-report scale of disability and health-related quality of life. We will use the subdomains of Communication, ADL/LDL, Life participation, Quality of life, Social Relationships, Depression.
Time Frame
one-month post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years old Native English Speakers Capacity to provide informed consent Right-handed Corrected to normal vision Left hemisphere cerebral stroke at least 6 months prior to testing Presence of severe-to-moderate, non-fluent aphasia, i.e. Aphasia Quotients of 0-50 on the Western Aphasia Battery-Revised (PsychCorp, 2007) Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender41,42 NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. Based on our ongoing aphasia studies, we expect that ~30% of participants will use hearing aids; we will not exclude these individuals but rather include hearing aid use as a covariate in analyses. Exclusion Criteria: Severe concurrent uncontrolled medical problems (e.g. cardiorespiratory impairment).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire F Honeycutt, PhD
Phone
4809658453
Email
claire.honeycutt@asu.edu
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire F Honeycutt, PhD
Phone
480-965-8453
Email
claire.honeycutt@asu.edu

12. IPD Sharing Statement

Learn more about this trial

Efficacy of START (Startle Rehabilitation Therapy) in the Treatment Stroke-induced Aphasia/Apraxia

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