Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly (3ECog)
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|ClinicalTrials.gov Identifier: NCT01661894|
Recruitment Status : Completed
First Posted : August 10, 2012
Last Update Posted : July 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease Mild Cognitive Impairment Age-Related Cognitive Decline Dementia||Device: BrainPalTM||Phase 1|
The world population has reached an unprecedented seven billion, with global population ageing increasing at a greater rate than total population growth. Between 1998 and 2030, the proportion of persons aged 65 years and over in Singapore will grow by about 3% annually compared to 1.0-1.3% in some developed nations. Specific cognitive deficits like inattention, dysexecutive functioning, and processing speed decline may affect a number of quality of life domains. Concurrent with these statistics, the maintenance of the highest possible level of cognitive functioning for as long as possible has become an important goal of aging successfully.
To contribute to the realization of this goal we propose to conduct a wait-list control pilot trial to examine the efficacy and safety of BrainpalTM for cognitive enhancement in the normal elderly. BrainpalTM uses a technology which analyzes brain waves captured through an electroencephalogram to determine the participants' state of attention. The training program developed using this patented technology may be useful for individuals who experience difficulty with memory and sustaining their attention.
BrainpalTM may represent one alternative means to enhance cognitive abilities and to slow down cognitive decline in the normal elderly. If demonstrated to be efficacious, this therapy may even help to delay the onset of dementia.
In addition, the rate of cognitive decline during the course of AD is possibly influenced by not only environmental but also genetic factors. To date, several genes, such as apolipoprotein E (APOE) and TOMM40 (translocase of outer mitochondrial membrane 40 homologue), have been identified to be probable genetic risk markers for AD. These genes have been shown to play a role in disease onset as well as rates of cognitive decline. For instance, studies have shown APOEε4 allele carriers to be associated with earlier and faster cognitive decline.
Therefore, we propose to analyse if there is any relationship between the genetic profiles of our participants and their performance in the BrainpalTM training program.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: Intervention
Subjects will undergo the BrainpalTM intervention for 24 sessions over the span of 8 weeks. Each session will take 30-minute to complete. The intervention group will undergo the BrainpalTM treatment in the first 8 weeks of the trial.
Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. It is a technology that enables people to interact with computers through their thoughts. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. The BCI system will take EEG recordings from the prefrontal cortex to determine the participants' state of attention with high specificity. The training program developed using this patented technology may be useful for individuals who experience difficulty with memory and sustaining their attention.
Other Name: Brain-Computer Interface
No Intervention: Wait-List Control
The waitlist control will start their 8 week treatment after the completion of the intervention group from week 9 onwards. They will undergo the BCI intervention for 24 sessions over the span of 8 weeks.
- Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: Comparison in the change of RBANS total score from baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group ]The Total Score on RBANS reflects the neurocognitive status of the participant by summing five index/domain scores. The domains are Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
- Number of Adverse Events reported by participants on the Safety Measurement Form [ Time Frame: The duration of 8 weeks of intensive BCI intervention sessions ]The Safety Measurement Form will be completed at the start of every BCI intervention visit (except the first visit). It will collect information on any safety concerns and/or side effects experienced by the participant since their last BCI intervention visit.
- Usability Measurement [ Time Frame: Before a subject exits from the study, including completion of the protocol and withdraw of consent ]The usability measurement collects feedback on the acceptability and usability of the BCI intervention program to improve user satisfaction in future trials.
- Relationship between genetic profile of participants and their performance on the BrainpalTM training program [ Time Frame: After the BrainpalTM training program is completed ]Blood samples will be collected from each subject for DNA extraction. The samples will be used to generate a genetic profile for each subject. The presence or absence of genes of interest (i.e. TOMM40 and APOEε4)on a subject's genetic profile will then be associated with his or her corresponding performance on BCI, as measured by his or her RBANS scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661894
|Duke-NUS Graduate Medical School|
|Singapore, Singapore, 169857|
|Principal Investigator:||Tih Shih Lee, MD, PhD||Duke-NUS Graduate Medical School|