Clinical trial NCT01661894: Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly
Official title: Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
First posted: 2012-08-10
Enrollment: 82
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to examine the efficacy of 8-weeks of a locally developed brain-computer interface based system (BrainpalTM)intervention for improving attention and memory in normal elderly. 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 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.

Eligibility criteria: Inclusion Criteria:

1. Age range between 60-70 years old
2. Clinical Dementia Rating (CDR) of 0.5\*
3. Geriatric Depression Scale (GDS) of 9 and below
4. Mini-Mental State Examination of 24 and above\*
5. Chinese ethnicity
6. Literate in English and/or Chinese
7. Able to travel to study site independently

   * In the case of conflicting CDR and MMSE scores, MMSE scores will supersede CDR scores.

Exclusion Criteria:

1. Any known neuropsychiatric disorders (such as epilepsy or mental retardation)
2. Involvement in another research study (aside from SLAS)

Primary outcomes:
measure: Total Score on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 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
Secondary outcomes:
measure: Number of Adverse Events reported by participants on the Safety Measurement Form
timeFrame: The duration of 8 weeks of intensive BCI intervention sessions
measure: Usability Measurement
timeFrame: Before a subject exits from the study, including completion of the protocol and withdraw of consent
Other outcomes:
measure: Relationship between genetic profile of participants and their performance on the BrainpalTM training program
timeFrame: After the BrainpalTM training program is completed
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Graduate Medical School
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Tih Shih Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee TS, Goh SJ, Quek SY, Phillips R, Guan C, Cheung YB, Feng L, Teng SS, Wang CC, Chin ZY, Zhang H, Ng TP, Lee J, Keefe R, Krishnan KR. A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy. PLoS One. 2013 Nov 18;8(11):e79419. doi: 10.1371/journal.pone.0079419. eCollection 2013.