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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
Sponsor:
Collaborators:
Agency for Science, Technology and Research
National University, Singapore
Singapore Clinical Research Institute
Singapore General Hospital
Information provided by (Responsible Party):
Lee Tih Shih, Duke-NUS Graduate Medical School

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Age-Related Cognitive Decline Dementia Device: BrainPalTM Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Device: BrainPalTM
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   60 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

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


Locations
Singapore
Duke-NUS Graduate Medical School
Singapore, Singapore, 169857
Sponsors and Collaborators
Duke-NUS Graduate Medical School
Agency for Science, Technology and Research
National University, Singapore
Singapore Clinical Research Institute
Singapore General Hospital
Investigators
Principal Investigator: Tih Shih Lee, MD, PhD Duke-NUS Graduate Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lee Tih Shih, Associate Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT01661894     History of Changes
Other Study ID Numbers: 11-363
First Posted: August 10, 2012    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Brain Diseases
Alzheimer Disease
Dementia
Cognitive Dysfunction
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders