Computerised Therapy in Chronic Stroke (CATChES)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2014 by Cambridge University Hospitals NHS Foundation Trust
Sponsor:
Collaborator:
Gates Cambridge Trust
Information provided by (Responsible Party):
Brielle Stark, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01928602
First received: August 19, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Chronic Aphasia
Behavioral: TherAppy Language App
Behavioral: Mind-Games

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Does Inner Speech Improve Access to Overt Speech in Aphasia Following Stroke? An fMRI Study Utilising Computerised Rehabilitation Software.

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Number of patients showing functional brain changes in inner speech circuits after computerised therapy [ Time Frame: Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Patient scores on effectiveness, feasibility and adherence to computerised therapy used on a portable tablet. [ Time Frame: Baseline and at completion of study (~18 weeks later) ] [ Designated as safety issue: No ]
    The secondary objective evaluates the effectiveness, feasibility and adherence to an example of computerised therapy. Analysis of this secondary objective will include qualitative feedback from participant responses on questionnaires and interviews, as well as quantitative feedback from the software's output and behavioural progress results.


Other Outcome Measures:
  • Number of patients showing language improvement after computerised therapy [ Time Frame: Baseline and at post-therapy (dependent upon crossover design, might be at 5 week or 10 week after baseline) ] [ Designated as safety issue: No ]
    Further investigate the relationship between inner and overt speech in the rehabilitation of chronic aphasia. Changes in language behaviour will be assessed by neuropsychological assessments, while changes in brain function will be assessed by functional imaging.

  • Number of patients showing language improvements after Computerised Therapy as compared to Mind-Games therapy [ Time Frame: 5 weeks and 10 weeks ] [ Designated as safety issue: No ]
    Investigate the therapeutic effect of the therapy. Changes in language behaviour will be assessed by neuropsychological assessments, while changes in brain function will be assessed by functional imaging. These will be assessed post-therapy A and post-therapy B for comparison.

  • Number of patients showing functional brain changes in inner speech circuits after computerised therapy as compared to mind-games therapy [ Time Frame: 5 weeks and 10 weeks ] [ Designated as safety issue: No ]
    Investigate the brain changes related to therapeutic effect. Changes in brain function will be measured by fMRI using an inner speech task.


Estimated Enrollment: 40
Study Start Date: November 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Expressive Aphasia Group A
  1. Behavioral: TherAppy Language App
  2. Behavioral: Mind-Games
Behavioral: TherAppy Language App
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.
Behavioral: Mind-Games
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.
Experimental: Expressive Aphasia Group B
  1. Behavioral: Mind-Games
  2. Behavioral: TherAppy Language App
Behavioral: TherAppy Language App
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.
Behavioral: Mind-Games
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

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)

Of those patients recruited, further exclusion from crossover study:

  • Demonstration of intact inner speech with good overt speech
  • Demonstration of poor inner speech with poor overt speech
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01928602

Contacts
Contact: Brielle Stark +441223 348401 brielle.stark@gmail.com
Contact: Elizabeth Warburton, Dr. eaw23@medschl.cam.ac.uk

Locations
United Kingdom
Addenbrooke's Hospital Not yet recruiting
Cambridge, United Kingdom, CB2 0QQ
Contact: Stephen Kelleher    +441223 217418      
Principal Investigator: Brielle Stark         
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Gates Cambridge Trust
Investigators
Study Director: Elizabeth Warburton, Dr. Cambridge University Hospitals
  More Information

Publications:
Responsible Party: Brielle Stark, PhD Candidate, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01928602     History of Changes
Other Study ID Numbers: A092982
Study First Received: August 19, 2013
Last Updated: January 23, 2014
Health Authority: United Kingdom: Wolfson Brain Imaging Centre
United Kingdom: University of Cambridge
United Kingdom: Cambridge University Hospitals NHS Foundation Trust

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Crossover
Chronic stroke
Stroke
Rehabilitation
Language Therapy
Aphasia
Aphasia Therapy
Computerised Therapy
Computerised Rehabilitation
Tablet
Apps
Aphasia Rehabilitation
Rehabilitation on Portable Tablets

Additional relevant MeSH terms:
Communication Disorders
Aphasia
Stroke
Speech Disorders
Language Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014