Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- NIH Toolbox-Cognitive Battery
Study Overview
Brief Summary
An observational study to determine outcomes of older adults who are under naturopathic medical care for cognitive complaints at a specific clinic in Southern California.
Detailed Description
This prospective observational study will examine patient outcomes associated with individualized, whole-system integrative medical care, provided by a naturopathic physician at a specific clinic in the state of California. Participants will be older adult patients of the clinic who present with objectively measurable cognitive dysfunction, and who elect to voluntarily participate in the study.
Participants' cognitive function will be assessed using validated objective (NIH Toolbox) and subjective (NIH Neuro-Quality of Life questionnaires) instruments. The primary outcomes are change from baseline to six months post-baseline in these two instruments.
Additionally, physical activity and sleep data will be tracked using wearable telemetry, and neurophysiological parameters will be measured with electroencephalography. Detailed treatment descriptions and adverse events will be tracked.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Community-dwelling adults ≥60 years of age.
- •Montreal Cognitive Assessment (MoCA) score of 12-
- •Able to independently make decisions.
- •Able to safely travel to North County Natural Medicine for 4 study visits and approximately 4 clinical visits, for a duration of 6 months.
- •Able to wear an Oura Ring, download data every 6 days, and keep the ring regularly charged for the duration of participants' involvement in the study.
- •A high school diploma or equivalent.
- •Ability to communicate via email.
- •Ability to independently fill out a computer-administered questionnaire.
- •Ability to withhold from seeing another integrative or alternative medicine provider for the 6 months of participation in the study.
Exclusion Criteria
- •Inability to read and write in English.
- •MoCA score >
- •A visual impairment that would prevent reading a computer screen.
- •Partial or full deafness.
- •A previous diagnosis of dementia (e.g. Alzheimer's Disease or any other kind of dementia).
- •Congenital cognitive impairment or disability.
- •Alcohol or substance abuse.
- •Serious somatic disease, neurodegenerative disease, acute onset of cognitive decline, or rapid neurological impairment.
- •Inability to bring an affiliate to the Informed Consent Consultation.
Outcomes
Primary Outcomes
NIH Toolbox-Cognitive Battery
Time Frame: Baseline, 6 months
Change from baseline to 6 months in scores on a computer-administered cognitive function test
Quality of Life in Neurological Disorders questionnaire (Neuro-QoL)
Time Frame: Baseline, 6 months
Change from baseline to 6 months in scores on a brief, validated questionnaire that monitors the physical, mental, and social effects experienced by individuals living with neurological conditions
Secondary Outcomes
- Physical activity(6 months)
- Peak alpha frequency(6 months post-baseline visit)
- Number and type of Adverse Events(From enrollment through study completion, a period of 6 months)
- Event-related potential (P300)(6 months post-baseline visit)
- Sleep quantity(6 months)
Investigators
Ryan Bradley
Primary Investigator
National University of Natural Medicine