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

NCT04816799 | Unknown Early Phase 1

• 1 other identifier: STUDY00005229
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Aphasia; Apraxia of Speech

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

START

EXPERIMENTAL

START (startle adjuvant rehabilitation therapy) will be applied.

Behavioral: Startle Adjuvant Rehabilitation Therapy (START)

Control

NO INTERVENTION

Subjects will train but without START

Interventions

Startle Adjuvant Rehabilitation Therapy (START) BEHAVIORAL

Exposure to loud acoustic stimulus during training of motor task (in this case speech).

START

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

RECRUITING

Related Publications (1)

• Swann Z, Tesman N, Rogalsky C, Honeycutt CF. Word Repetition Paired With Startling Stimuli Decreases Aphasia and Apraxia Severity in Severe-to-Moderate Stroke: A Stratified, Single-Blind, Randomized, Phase 1 Clinical Trial. Am J Speech Lang Pathol. 2023 Nov 6;32(6):2630-2653. doi: 10.1044/2023_AJSLP-22-00296. Epub 2023 Sep 12.

  PMID: 37699161 DERIVED

MeSH Terms

Conditions

Stroke; Aphasia; Apraxias

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Psychomotor Disorders

Central Study Contacts

Claire F Honeycutt, PhD

CONTACT

4809658453; claire.honeycutt@asu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 25, 2021
• Study Start: July 22, 2020
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

US (1)