Brain-Computer Interface System for Training Memory and Attention in Elderly

NCT ID: NCT02228187

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment; Age-Related Cognitive Decline; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

BCI Intervention

Subjects will undergo the Brain-Computer Interface Intervention for 24 sessions over the span of 8 weeks. Each session will take 30-minute to complete. The intervention group will undergo the intervention in the first 8 weeks of the trial.

Group Type: ACTIVE_COMPARATOR

Brain-Computer Interface

Intervention Type: DEVICE

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.

Waitlist Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brain-Computer Interface

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agency for Science, Technology and Research

OTHER

Sponsor Role: collaborator

National University of Singapore

OTHER

Sponsor Role: collaborator

Singapore Clinical Research Institute

OTHER

Sponsor Role: collaborator

Singapore General Hospital

OTHER

Sponsor Role: collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role: collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role: lead

Responsible Party

Lee Tih Shih

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tih Shih Lee, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke-NUS Medical School, Duke University

Locations

Duke-NUS Medical School

Singapore, , Singapore

Countries

Singapore

Other Identifiers

B-14-099

Identifier Type: -

Identifier Source: org_study_id