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

NCT ID: NCT04816799

Last Updated: 2022-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2022-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

START

START (startle adjuvant rehabilitation therapy) will be applied.

Group Type: EXPERIMENTAL

Startle Adjuvant Rehabilitation Therapy (START)

Intervention Type: BEHAVIORAL

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

Control

Subjects will train but without START

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Startle Adjuvant Rehabilitation Therapy (START)

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

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: lead

Responsible Party

Claire Honeycutt

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Arizona State University

Tempe, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Claire F Honeycutt, PhD

Role: CONTACT

claire.honeycutt@asu.edu

4809658453

Facility Contacts

Claire F Honeycutt, PhD

Role: primary

claire.honeycutt@asu.edu

480-965-8453

References

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.

Reference Type: DERIVED

PMID: 37699161 (View on PubMed)

Other Identifiers

STUDY00005229

Identifier Type: -

Identifier Source: org_study_id