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

NCT01661894 | Completed Phase 1

• 1 other identifier: 11-363
• Study Type: interventional
• Target: 82
• 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 (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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Total Score on 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 baseline (Week 1) to post-treatment (Week 8) in Intervention Group versus Wait-List Control group

Secondary Outcomes (2)

• Number of Adverse Events reported by participants on the Safety Measurement Form

  The duration of 8 weeks of intensive BCI intervention sessions

• Usability Measurement

  Before a subject exits from the study, including completion of the protocol and withdraw of consent

Other Outcomes (1)

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

  After the BrainpalTM training program is completed

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Wait-List Control

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

BrainPalTM 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.

Also known as: Brain-Computer Interface

Intervention

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range between 60-70 years old
• Clinical Dementia Rating (CDR) of 0.5\*
• Geriatric Depression Scale (GDS) of 9 and below
• Mini-Mental State Examination of 24 and above\*
• Chinese ethnicity
• Literate in English and/or Chinese
• Able to travel to study site independently
• In the case of conflicting CDR and MMSE scores, MMSE scores will supersede CDR scores.

You may not qualify if:

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

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

Study Sites (1)

Duke-NUS Graduate Medical School

Singapore, Singapore, 169857, Singapore

Location

Related Publications (1)

• 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.

  PMID: 24260218 DERIVED

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 Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 17, 2012
• First Posted: August 10, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 25, 2014

Record last verified: 2014-07

Locations

SG (1)