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

Stroke Clinical Trial

— START  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04816799
• Other study ID #: STUDY00005229
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 22, 2020
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: Arizona State University
• Contact: Claire F Honeycutt, PhD
• Phone: 4809658453
• Email: claire.honeycutt[@]asu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: August 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aphasia
• Apraxia of Speech
• Apraxias
• Stroke

Intervention

Behavioral:
• Startle Adjuvant Rehabilitation Therapy (START)
Exposure to loud acoustic stimulus during training of motor task (in this case speech).

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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