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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Aphasia; Apraxia of Speech
• Intervention / Treatment: Behavioral: Startle Adjuvant Rehabilitation Therapy (START)

• Study Type: Interventional
• Enrollment (Anticipated): 54
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Claire F Honeycutt, PhD; Phone Number: 4809658453; Email: claire.honeycutt@asu.edu

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85287
      • Recruiting
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: START; START (startle adjuvant rehabilitation therapy) will be applied.	Behavioral: Startle Adjuvant Rehabilitation Therapy (START); Exposure to loud acoustic stimulus during training of motor task (in this case speech).
NO_INTERVENTION: Control; Subjects will train but without START

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	end of training
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.	one month post
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.	end of training
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.	one-month post
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.	Baseline, end of training, one-month post
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.	one-month post

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 22, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): August 1, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 24, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Psychomotor Disorders; Language Disorders; Communication Disorders; Speech Disorders; Stroke; Aphasia; Apraxias
• Other Study ID Numbers: STUDY00005229

Drug and device information, study documents

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