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Completed

NCT Number: NCT04426162

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurocore Brain Performance Center, Boca Raton, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-domain Intervention

Other

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.

Primary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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.

Other outcomes

  1. Change in Neurotrax BrainCare Testing Suite

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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.

  2. Change in Beck Depression Inventory-II (BDI)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    The BDI is a twenty-one item self-report inventory, and one of the most widely used instruments for measuring severity of depression.

  3. Change in Beck Anxiety Inventory (BAI)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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.

  4. Change in Insomnia Severity Index (ISI)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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.

  5. Change in Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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).

  6. Change in Work and Social Adjustment Scale (WSAS)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    The WSAS is a five-item self-report inventory, which provides a measure of global functional impairment, due to memory concerns.

  7. Change in Quantitative Electroencephalography (QEEG)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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.

  8. Change in Heart Rate Variability (HRV)

    Time frame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

    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).

Sponsors and collaborators

Lead sponsor

Neurocore

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2020
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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