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

NCT02228187 | Completed Phase 2

• 1 other identifier: B-14-099
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Total Score of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  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.

  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 (3)

• Sum of Scaled Score of the Rivermead Behavioral Memory Test-II

  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

• Number of Adverse Events/Serious Adverse Events Reported

  Throughout the intervention period (Up to 20 weeks) for both groups

• Usability Measure of the Brain-Computer Interface training system

  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 (2)

• Relationship between genetic profile of participants and their performance on the training program

  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)

• Changes in functional MRI

  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

Study Arms (2)

BCI Intervention

ACTIVE COMPARATOR

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.

Device: Brain-Computer Interface

Waitlist Control Group

NO INTERVENTION

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.

Interventions

Brain-Computer Interface 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.

BCI Intervention

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• Agency for Science, Technology and Research: collaborator
• National University of Singapore: collaborator
• Singapore Clinical Research Institute: collaborator
• Singapore General Hospital: collaborator
• Tan Tock Seng Hospital: collaborator

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Tih Shih Lee, MD, PhD

  Duke-NUS Medical School, Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 28, 2014
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

SG (1)