Computerised Therapy in Chronic Stroke

NCT01928602 | Completed DMC

• 1 other identifier: A092982
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The few studies looking systematically into the neurophysiological and neuropsychological components of available therapies for chronic aphasia are highly heterogeneous in nature. Results from these studies have, unsurprisingly, indicated heterogeneous results, such as dissimilar neural outcomes associated with neuropsychological gains. There is, therefore, no consensus of how a successful therapy- that is, one that produces a measurable language gain in either production or comprehension -impacts the functional language networks of the brain in a specific type of aphasia population. A recent study has shown that inner speech (the imagination of speech) involves networks and areas dissociable from those implicated in speech production. Further, behavioural analysis has shown an interesting discrepancy between inner speech and overt speech (also called speech production) in a small chronic aphasia population: some participants elicited poor inner speech coupled with relatively intact overt speech, while others elicited relatively intact inner speech coupled with poor overt speech. This unexplored discrepancy implies that inner speech and speech production are dissociable, though share similar networks. This discrepancy, and the notion that these speech components share a similar network, drives this study's hypothesis that improvement in speech production after rehabilitation might be facilitated by an intact inner speech network. Much as good athletes visualise their performance before the actual event in order to increase their chances of success, so too might intact inner speech facilitate speech production, helping to visualise the word in order to increase the success of produced speech. By studying a specific component of speech-inner speech-in a relatively homogeneous population of chronic expressive aphasics, the present study provides an explicit, critical means of understanding neurophysiological (as assessed by functional magnetic resonance imaging) and neuropsychological (as assessed by language batteries and personal questionnaires/interviews) changes occurring during speech therapy. As a secondary objective, this study will explore the effectiveness, feasibility and adherence to an at-home computerised aphasia software delivered via a portable tablet.

Conditions

Chronic Aphasia

Keywords

Crossover; Chronic stroke; Stroke; Rehabilitation; Language Therapy; Aphasia; Aphasia Therapy; Computerised Therapy; Computerised Rehabilitation; Tablet; Apps; Aphasia Rehabilitation; Rehabilitation on Portable Tablets

Outcome Measures

Primary Outcomes (1)

• Number of patients showing functional brain changes in inner speech circuits after computerised therapy

  The primary outcome of this research is to investigate the brain changes related to computerised therapy in inner speech circuits in chronic aphasia. Changes in brain function will be measured by fMRI using an inner speech task.

  Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline)

Secondary Outcomes (1)

• Patient scores on effectiveness, feasibility and adherence to computerised therapy used on a portable tablet.

  Baseline and at completion of study (~18 weeks later)

Other Outcomes (3)

• Number of patients showing language improvement after computerised therapy

  Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline)

• Number of patients showing language improvements after Computerised Therapy as compared to Mind-Games therapy

  5 weeks and 10 weeks

• Number of patients showing functional brain changes in inner speech circuits after computerised therapy as compared to mind-games therapy

  5 weeks and 10 weeks

Study Arms (2)

Expressive Aphasia Group A

EXPERIMENTAL

1. Behavioral: TherAppy Language App 2. Behavioral: Mind-Games

Behavioral: TherAppy Language App; Behavioral: Mind-Games

Expressive Aphasia Group B

EXPERIMENTAL

1. Behavioral: Mind-Games 2. Behavioral: TherAppy Language App

Behavioral: TherAppy Language App; Behavioral: Mind-Games

Interventions

TherAppy Language App BEHAVIORAL

Language TherAppy combines the receptive exercises of Comprehension TherAppy and Reading TherAppy with the expressive training of Naming TherAppy and Writing TherAppy. The app uses the same core functional vocabulary (nouns, verbs, \& adjectives) and over 700 clear pictures. Each app tracks data, sends professional e-mailed reports, and has built-in levels, cues, and options.

Expressive Aphasia Group A; Expressive Aphasia Group B

Mind-Games BEHAVIORAL

A mind-game app is said to improve brain functioning at any age. The chosen app will give feedback such as score history, and progress reports. Tasks will focus on attention, memory spatial awareness and executive function.

Expressive Aphasia Group A; Expressive Aphasia Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Left hemisphere stroke
• Clinical presentation of first ever stroke
• Nonfluent/Expressive Aphasia: impairment in language production and spared language comprehension
• Age \>18 years
• Adequate co-operation for scanning
• Right handed before stroke as tested with the Edinburgh inventory
• Native British-English speakers (this is due to the nature of the fMRI task and inner speech battery, which rely upon words that are rhymes or homophones in the British English language)
• No history of neurological or psychiatric disorders
• No current specific cognitive deficit other than the language deficit
• No contra-indication to MRI scan as indicated by the WBIC protocol
• Patients able to lie flat in the scanner for 2 hours
• Consent obtained prior to initiating the study from the patient, in accordance with Local Research Ethics Committee guidelines
• Stroke and subsequent aphasia having been present for more than 12 months (ie, chronic)

You may not qualify if:

• For successful fMRI scans (relevant for all participants):
• Women with any chance of pregnancy
• Claustrophobia
• Any contra-indication to MRI as indicated by the WBIC protocol
• Concomitant medical disorder that means the patient is unable to lie flat comfortably in the scanner for a maximum of 2 hours (e.g. poorly controlled or severe respiratory disease or severe joint disease)
• All recruited patients:
• History of significant pre-morbid cognitive impairment
• Alcohol or illicit drug abuse
• Severe deafness or visual impairment
• History of significant neurological disease (e.g. epilepsy, multiple sclerosis)
• Major organ failure that may complicate imaging studies (e.g. significant cardiac or liver disease)
• Demonstration of intact inner speech with good overt speech
• Demonstration of poor inner speech with poor overt speech

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Gates Cambridge: collaborator

Study Sites (1)

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Related Publications (1)

• Stark BC, Warburton EA. Improved language in chronic aphasia after self-delivered iPad speech therapy. Neuropsychol Rehabil. 2018 Jul;28(5):818-831. doi: 10.1080/09602011.2016.1146150. Epub 2016 Feb 29.

  PMID: 26926872 RESULT

MeSH Terms

Conditions

Stroke; Aphasia

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

Study Officials

• Elizabeth Warburton, Dr.

  Cambridge University Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 27, 2013
• Study Start: November 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: February 1, 2016
• Last Updated: January 10, 2018

Record last verified: 2018-01

Locations

GB (1)