Evaluating Short-term Effects of Home-based Computerized Brain Fitness Exercises in Adult Cochlear Implants Users
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Purpose
In this study we are testing computer-based brain fitness exercises. The games are designed to improve people's cognitive abilities brain functions, like memory, concentration, and ability to do two things at once. We are testing whether this cognitive training brain exercises will improve understanding of spoken sentences speech comprehension in people who use cochlear implants. We predict that cognitive training will improve speech comprehension in cochlear implant users.
| Condition | Intervention |
|---|---|
|
Deafness Speech Intelligibility |
Other: Cognitive fitness training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluating Short-term Effects of Home-based Computerized Multi-domain Cognitive Training in Adult Cochlear Implants Users: A Prospective Randomized Intervention Study |
- AzBio Sentence test - change in score from baseline to post-training [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]Sentences are played along with masking noise (multi-talker babble). Participants must repeat each sentence as they heard it. Accuracy in repeating the sentences is the outcome measure.
- Change from Baseline in CANTABeclipse for clinical trials [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]It is a method of assessing the brain-functions of a person using computerized non-linguistic tests by touch screen technology making it rapid and safe. It has been widely used globally to assess brain-functions in more than 100 disorders. More than 700 articles have been published using CANTABeclipse by over 500 academic institutions or industry researchers in 60 different countries. Tasks are performed by touch screen technology. It assesses brain-functions such as planning, problem solving, working memory etc.
- Change from Baseline in Speech Spatial Qualities questionnaire [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]The Spatial Speech Qualities of Hearing scale questionnaire (SSQ; Gatehouse & Noble, 2004) is used to assess the self reported hearing disabilities across several domains such as hearing speech in challenging contexts and to the directional, distance and movement components of spatial hearing.
- Change from Baseline in CogniFit NeuroPsychological Assessment [ Time Frame: Baseline, Weeks 10, 20 and 30 ] [ Designated as safety issue: No ]The CogniFit Neuropsychological assessment is a multi domain cognitive task. It measures 18 cognitive abilities such as visuospatial working memory, visuospatial learning, focused attention, updating, monitoring etc. (Haimov et al., 2008; Peretz et al., 2011b; Shatil et al., 2010; Verghese et al., 2010)
- Adherence record [ Time Frame: Upto 30 weeks ] [ Designated as safety issue: No ]Access usage data from CogniFit website will be recorded. Recording includes time spent on each session (start and end time), number of games played during each session
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Immediate cognitive fitness training
After the initial baseline evaluation, the immediate treatment group participants will receive individualized multi-domain cognitive training and standard of care. Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval. After 10 weeks of cognitive fitness training, participants in this group will switch to a 20 week "no intervention" period where they receive only standard of care treatment.
|
Other: Cognitive fitness training
Computer-based training of basic cognitive functions. It has activities under two headings,
Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval. |
|
Delayed cognitive fitness training
After the initial baseline evaluation, the delayed cognitive fitness training group participants will receive only standard of care for 10 weeks ("no intervention" period). Starting in week 11, participants in this arm will receive individualized multi-domain cognitive training and standard of care. Cognitive training includes at least 1/2 hour per session, 3 days per week, throughout the 10 week interval. After 10 weeks of cognitive fitness training, participants will go for another 10 weeks with only standard of care treatment.
|
Other: Cognitive fitness training
Computer-based training of basic cognitive functions. It has activities under two headings,
Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval. |
Detailed Description:
Cochlear implant rehabilitation is a life long process in spite of advanced innovative implant technology. Existing standard therapy is inadequate for some people, because even after years of surgery many implant users does not obtain significant benefits, like improved understanding of spoken sentences. In many cases it seems that the speech comprehension deficits are linked to particular cognitive functions in cochlear implant users, including memory and attention. In this study we will test whether a computer-based set of "cognitive fitness" or "brain training" games designed to improve memory and attention will help cochlear implant users to understand speech better.
Cochlear implant users will complete 10 weeks of computer-based cognitive training on their home computers. Half of participants will do this training immediately after being enrolled in the study; the other half will receive the training beginning 10 weeks after they are enrolled. Speech comprehension and cognitive abilities will be assessed at baseline, 10, 20 and 30 weeks in all participants.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult cochlear implant users aged 19 or above
- Access to an internet-connect device that supports flash, and basic computer skills
- Medically stable patients
Exclusion Criteria:
- Patients with epilepsy, severe visual and cognitive difficulties, chronic fatigue syndrome, and serious co-morbid conditions which could be exacerbated by the computer training games will be excluded for safety reasons.
- Patients who are unlikely to adhere to the intervention due to dementia, Parkinson's disease, Parkinson-plus syndrome, movement disorders or disability that would impair the person's ability to perform the training (e.g., problems with attention, alertness, or learning disorders)
- Participants who cannot speak English (since study materials are only in English), or unable to give consent.
Contacts and Locations| Contact: Aaron J Newman, PhD | +1-902-448-1973 | Aaron.Newman@dal.ca |
| Contact: Amit Bansal, MBBS, DFM | +1-902-448-7786 | amitjgn@gmail.com |
| Canada, Nova Scotia | |
| NeuroCognitive Imaging Lab, Dalhousie University | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 4R2 | |
| Contact: Aaron Newman, PhD 19024481973 Aaron.Newman@dal.ca | |
| Contact: Amit Bansal, MBBS,DFM 19024487786 amitjgn@gmail.com | |
| Principal Investigator: Aaron Newman, PhD | |
| Sub-Investigator: Amit Bansal, MBBS, DFM | |
| Principal Investigator: | Aaron Newman, PhD | Dalhousie University, Canada |
| Principal Investigator: | Christoph Gradmann | University of Oslo, Norway |
More Information
Additional Information:
No publications provided
| Responsible Party: | Aaron Newman, Affiliated Scientist, Capital District Health Authority, Canada |
| ClinicalTrials.gov Identifier: | NCT01732887 History of Changes |
| Other Study ID Numbers: | NCIL-CI-CF |
| Study First Received: | November 14, 2012 |
| Last Updated: | January 7, 2013 |
| Health Authority: | Canada: Ethics Review Committee Norway: Ethics Committee |
Keywords provided by Capital District Health Authority, Canada:
|
cochlear implants speech comprehension cognitive training cognitive fitness |
intervention memory attention rehabilitation |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013