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

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multi-domain Intervention
Sponsored by
Neurocore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurocore Brain Performance Center
  • Neurocore Brain Performance Center
  • Neurocore Brain Performance Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Memory Boot Camp Participants

Arm Description

All subjects undergo a 12-week control period, followed by a multi-domain 12-week memory program.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 13, 2020
Last Updated
June 8, 2020
Sponsor
Neurocore
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1. Study Identification

Unique Protocol Identification Number
NCT04426162
Brief Title
Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)
Official Title
Effects of Memory Boot Camp on Brain Function in Adults With Symptoms of Mild Cognitive Impairment (MCI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
April 24, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurocore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Boot Camp Participants
Arm Type
Experimental
Arm Description
All subjects undergo a 12-week control period, followed by a multi-domain 12-week memory program.
Intervention Type
Other
Intervention Name(s)
Multi-domain Intervention
Intervention Description
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 Outcome Measure Information:
Title
Change in Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Other Pre-specified Outcome Measures:
Title
Change in Neurotrax BrainCare Testing Suite
Description
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.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Beck Depression Inventory-II (BDI)
Description
The BDI is a twenty-one item self-report inventory, and one of the most widely used instruments for measuring severity of depression.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Beck Anxiety Inventory (BAI)
Description
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.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Insomnia Severity Index (ISI)
Description
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.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Pittsburgh Sleep Quality Index (PSQI)
Description
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).
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Work and Social Adjustment Scale (WSAS)
Description
The WSAS is a five-item self-report inventory, which provides a measure of global functional impairment, due to memory concerns.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Quantitative Electroencephalography (QEEG)
Description
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.
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Title
Change in Heart Rate Variability (HRV)
Description
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).
Time Frame
Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Neurocore Brain Performance Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Neurocore Brain Performance Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Neurocore Brain Performance Center
City
Grandville
State/Province
Michigan
ZIP/Postal Code
49418
Country
United States

12. IPD Sharing Statement

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

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