Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)

This is a prospective controlled clinical trial to determine the effects of a 12-week Memory Boot Camp (MBC) program on cognitive function in older adults with symptoms of Mild Cognitive Impairment.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Other: Multi-domain Intervention

Detailed Description

This prospective trial evaluates the 12-week, multi-domain Memory Boot Camp program for adults ages 55 to 85 with symptoms of mild cognitive impairment. The Memory Boot Camp program incorporates neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction. Participants are evaluated via neurocognitive assessments, questionnaires, quantitative electroencephalography parameters, and heart rate variability parameters at four time points: baseline, pre-program, post-program, and follow-up. The trial included a 12-week waiting period between baseline and pre-program, such that each participant acts as their own control, and follow-up takes place six months after completion of the program.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Neurocore Brain Performance Center
    • Palm Beach Gardens, Florida, United States, 33410
      • Neurocore Brain Performance Center
  • Michigan
    • Grandville, Michigan, United States, 49418
      • Neurocore Brain Performance Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjective memory concerns
• At least a high school education
• Having a current primary care doctor (or agreement to get a primary care doctor)
• Ability to read and write English
• Time availability of 4-5 hours/week
• Be in good general health

Exclusion Criteria:

• Major depression
• Known neurological illness (e.g. Alzheimer's or other dementia, Parkinson's, epilepsy, multiple sclerosis)
• Serious psychiatric diagnosis
• Substance abuse
• Complete blindness or deafness
• Plans to be out of town for more than 10 days during the active phase of the trial
• Current or past client of the Sponsor
• Complete blindness or deafness
• Employee or family member of Sponsor employee

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Memory Boot Camp Participants; All subjects undergo a 12-week control period, followed by a multi-domain 12-week memory program.	Other: Multi-domain Intervention; Intervention includes neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Montreal Cognitive Assessment (MoCA)	The MoCA is a validated, brief assessment tool that measures MCI and is widely used. Individuals are scored on seven different domains: visuospatial/executive, naming, attention, language, abstraction, delayed recall, and orientation.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Neurotrax BrainCare Testing Suite	Neurotrax was originally developed and validated for the diagnosis of MCI in clinical practice and in research (at that time it was called "Mindstreams"). Neurotrax has been further validated since then in both demented and normally-aging populations.There are 7 domains covered by this series of tests: Memory, Executive Function (Thinking), Attention, Visual Spatial, Verbal Function, Problem Solving and Working Memory.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Beck Depression Inventory-II (BDI)	The BDI is a twenty-one item self-report inventory, and one of the most widely used instruments for measuring severity of depression.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Beck Anxiety Inventory (BAI)	The BAI is a twenty-one item self-report inventory, and is a widely-used instrument for measuring subjective, somatic, or panic-related symptoms of anxiety.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Insomnia Severity Index (ISI)	The ISI is a 7-item self-report inventory. The questionnaire is designed to assess the subject's sleep patterns and presence of or severity of insomnia during a 14-day period.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a 19-item self-report inventory. The survey is designed to measure sleep quality and disturbances over a one-month interval in clinical populations. The nineteen items generate a global score as well as seven component scores (subjective sleep quality; sleep latency; sleep duration; habitual sleep efficacy; sleep disturbances; use of sleeping medication; daytime dysfunction).	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Work and Social Adjustment Scale (WSAS)	The WSAS is a five-item self-report inventory, which provides a measure of global functional impairment, due to memory concerns.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Quantitative Electroencephalography (QEEG)	EEG activity will be collected 19 electrode locations, according to standard 10-20 site placement standards. Information about EEG absolute and relative power from 1 - 30 Hz will be collected at every location, as well as pairwise combinations of coherence and phase measures.Data will be compared to the Neuroguide age-normed QEEG database.	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Change in Heart Rate Variability (HRV)	HRV parameters include mean heart rate and two common time-domain measures used to calculate HRV: the standard deviation of normal to normal beat intervals (SDNN) and the root mean square of successive normal to normal beat interval differences (RMSSD).	Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

Collaborators and Investigators

• Sponsor: Neurocore

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2017
• Primary Completion (Actual): April 24, 2019
• Study Completion (Actual): April 24, 2019

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 16-127

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No