Clinical trial NCT02540889: Listen in: Developing and Testing a Therapy Application for Patients With Speech Comprehension Deficits After Stroke.
Official title: Listen-In: the Development and Testing of a Web-based Therapy Application for Patients With Impaired Speech Comprehension Caused by Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
name: Cambridge University Hospitals NHS Foundation Trust
First posted: 2015-09-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen-In will provide an effective speech comprehension training tool that patients with aphasia can use to practice independently. This will free up therapists time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.

Detailed description: The main aim is to develop and test the clinical efficacy of a novel, web based, rehabilitation application. Listen In will provide an effective speech comprehension training tool that patients can use to practice independently. This will free up SALT time to provide additional assessment, supervision and functional intervention in a highly cost effective manner.

Phase 1 (24 months. London, Newcastle, Cambridge): Development of Listen In, including diagnostic and therapeutic components, driven by patient user's feedback (alpha and beta testing). The intervention is detailed below and is based on current SALT practice. It will be adaptive, provide feedback and target auditory perception at many levels: the phonemic, lexical and sentence level processing of heard verbal stimuli, as well as auditory short term memory and nonverbal sound discrimination.

Phase 2 (12 months. London and Cambridge): A pilot, randomised, crossover, clinical trial of Listen-In in a group of aphasic patients in the chronic post-stroke period. A power calculation suggests that we will need 36 patents, 18 in each arm. The comparison will be standard SALT clinical care. The main outcome measure is a clinically relevant improvement on the comprehension of spoken language score of the Comprehensive Aphasia Test (Swinburn, 2004). Secondary outcomes include improvements in social activity and participation. The milestones for this phase will be: 50% recruitment into study and last patient, last visit.

Phase 3 (funded outside i4i grant) will be the rollout of the therapy application on the internet with a pragmatic trial of whether therapy gains can be made outside the confines of a clinical trial. The comparison will be on similar outcome measures as Phase 2 with a control test on sustained attention (internal control) that we predict will not improve with therapy.

Eligibility criteria: Inclusion Criteria:

* any type of stroke but greater than 6 months post onset
* evidence of receptive aphasia
* English as their main language
* able to give informed consent
* age 18 years or above
* no diagnosis of degenerative brain disease.

Exclusion Criteria:

* Stroke less than 6 months post onset
* No evidence of receptive aphasia
* English not their main language
* Unable to give informed consent
* Less than 18 years old
* diagnosis of degenerative brain disease.

Primary outcomes:
measure: Improvement in auditory comprehension on the comprehensive aphasia test.
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
Secondary outcomes:
measure: Improvement in functional communication
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
measure: Improvement in production of language
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
measure: Performance on the Sustained attention to response task
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
measure: Environmental sounds test
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
measure: Test of semantics
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
measure: Improvement in written language comprehension
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
measure: Improvement on auditory descrimination
timeFrame: Measured over 36 weeks (0,12,24,36) weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCLondon
Study officials:
affiliation: ucl
name: Alex Leff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleming V, Brownsett S, Krason A, Maegli MA, Coley-Fisher H, Ong YH, Nardo D, Leach R, Howard D, Robson H, Warburton E, Ashburner J, Price CJ, Crinion JT, Leff AP. Efficacy of spoken word comprehension therapy in patients with chronic aphasia: a cross-over randomised controlled trial with structural imaging. J Neurol Neurosurg Psychiatry. 2020 Nov 5;92(4):418-24. doi: 10.1136/jnnp-2020-324256. Online ahead of print.