Effectiveness of a Brain-Computer Interface Based System for Cognitive Enhancement in the Normal Elderly (3ECog)

Duke University

Status and phase: Completed; Phase 1

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

Treatments: Device: BrainPalTM

Study type: Interventional

Funder types: Other

Identifiers

NCT01661894

11-363

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 60 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Intervention

Active Comparator group

Description:

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.

Treatment:

Device: BrainPalTM

Wait-List Control

No Intervention group

Description:

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.