Clinical trial NCT04426162: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: Neurocore
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 76
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Secondary outcomes:
Other outcomes:
measure: Change in Neurotrax BrainCare Testing Suite
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Beck Depression Inventory-II (BDI)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Beck Anxiety Inventory (BAI)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Work and Social Adjustment Scale (WSAS)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Quantitative Electroencephalography (QEEG)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
measure: Change in Heart Rate Variability (HRV)
timeFrame: Baseline (Month 0), program start (Month 3), program completion (Month 6), and 6-month post-program follow-up (Month 12).
Locations:
city: Boca Raton
country: United States
facility: Neurocore Brain Performance Center
state: Florida
city: Palm Beach Gardens
country: United States
facility: Neurocore Brain Performance Center
state: Florida
city: Grandville
country: United States
facility: Neurocore Brain Performance Center
state: Michigan
Study officials:
References: