Clinical trial NCT02228187: Brain-Computer Interface System for Training Memory and Attention in Elderly
Official title: Brain-computer Interface System for Training Memory and Attention in Elderly With Subjective Memory Deficits and Age Related Cognitive Decline (ARCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Age-Related Cognitive Decline
Dementia
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
name: National University of Singapore
name: Singapore Clinical Research Institute
name: Singapore General Hospital
name: Tan Tock Seng Hospital
First posted: 2014-08-28
Enrollment: 240
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The primary objective is to examine the efficacy of 8-weeks of a locally developed brain-computer interface based system intervention for improving attention and memory in healthy elderly and those with age related cognitive decline. We hypothesize that elderly who have completed the training program will have significant improvement in their attention and memory compared to the controls, based on the Repeatable Battery for the Assessment of Neuropsychological Status.

Detailed description: 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 trial to examine the efficacy of this brain-computer interface based intervention for cognitive enhancement in elderly. This intervention 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.

This intervention 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 training program.

There are no published studies that look at how cognitive training may be associated with changes in the metabolism and functional connectivity of the brain. Therefore, our study also aims to carry out functional MRI of the brain before and after training to gain a finer understanding of the changes associated with our BCI-based cognitive training.

Eligibility criteria: Inclusion Criteria:

* Age 60-80 years old
* Clinical Dementia Rating (CDR) of 0-0.5
* Mini Mental State Examination (MMSE) of 24 and above
* Geriatric Depression Scale (GDS) of 4 and below
* Chinese Ethnicity
* Literate in English
* Able to travel to study site independently

Exclusion Criteria:

* Any known neuropsychiatric disorders (such as epilepsy or mental retardation)
* Involvement in another research study (aside from the Singapore Longitudinal Ageing Study)
* Gross hearing, visual or speech impairment that are uncorrected
* Color Blindness
* Intake of the following medications: Rivastigmine, Donepezil, Galantamine or Memantine.

Primary outcomes:
measure: Total Score of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: Comparison in the change of RBANS total score from pre-treatment (Week 0) to post-treatment (Week 9) in Intervention Group versus Waitlist-Control group
Secondary outcomes:
measure: Sum of Scaled Score of the Rivermead Behavioral Memory Test-II
timeFrame: Comparison in the change of RBMT-2 sum of scale score from pre-treatment (Week 0) to post-treatment (Week 9) in Intervention Group versus Waitlist-Control group
measure: Number of Adverse Events/Serious Adverse Events Reported
timeFrame: Throughout the intervention period (Up to 20 weeks) for both groups
measure: Usability Measure of the Brain-Computer Interface training system
timeFrame: At the end of the 8 weeks of treatment for both groups (Week 20 for the Intervention group, Week 29 for the Waitlist-Control group)
Other outcomes:
measure: Relationship between genetic profile of participants and their performance on the training program
timeFrame: Blood samples will be collected pre-treatment (Week 0) and at end of study participation (Week 20 for Intervention group, Week 29 for Waitlist-Control group)
measure: Changes in functional MRI
timeFrame: Comparison in the change of fMRI during: Pre-treatment (Week 0), post-treatment (Week 9), and post booster sessions (Week 20) for the Intervention group; Baseline (Week 0), pre-treatment (Week 9), and post-treatment (Week 20) for Waitlist-control group
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Medical School
Study officials:
affiliation: Duke-NUS Medical School, Duke University
name: Tih Shih Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: