Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation (ITHNCLR)
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|ClinicalTrials.gov Identifier: NCT04284449|
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : July 24, 2020
|Condition or disease||Intervention/treatment|
|Cognitive Dysfunction||Other: Whole-practice cognitive optimization|
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 Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation|
|Actual Study Start Date :||February 24, 2020|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||August 2022|
This is a whole-practice precision medicine model in which a participant-specific Naturopathic treatment program is developed and implemented for older adults with cognitive complaints.
Other: Whole-practice cognitive optimization
This intervention is a whole-practice intervention that may include nutritional assessment & supplementation, determination of food sensitivities and dietary changes, natural products such as herbal anti-inflammatories, assessment of whole body-burden of toxicants (such as heavy metals and fungal toxins) and steps to reduce exposures, and behavioral changes such as exercise, meditation, and sleep hygiene optimization.
- 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
- Event-related potential (P300) [ Time Frame: 6 months post-baseline visit ]Change from baseline to 6 months of an auditory event provoked change in electrical potential of the brain, measured noninvasively by electroencephalography (EEG)
- Peak alpha frequency [ Time Frame: 6 months post-baseline visit ]Change from baseline to 6 months of the peak (highest intensity) frequency in electrical activity of the brain between 8 Hz and 12 Hz, measured noninvasively by electroencephalography (EEG)
- Physical activity [ Time Frame: 6 months ]Change from baseline to 6 months in participants' overall physical activity as measured with telemetry from a wrist-worn activity tracker
- Sleep quantity [ Time Frame: 6 months ]Change from baseline to 6 months in participants' total sleep as measured with telemetry from a wrist-worn activity tracker
- Number and type of Adverse Events [ Time Frame: From enrollment through study completion, a period of 6 months ]Total number of adverse events and serious adverse events (using NIH's Common Terminology Criteria for Adverse Events version 4.0)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284449
|Contact: Ryan Bradley, NDfirstname.lastname@example.org|
|Contact: John Phipps, PhDemail@example.com|
|United States, California|
|North County Natural Medicine||Recruiting|
|Encinitas, California, United States, 92024|
|Principal Investigator:||Ryan Bradley, ND||National University of Natural Medicine|
|Principal Investigator:||Heather Sandison, ND||North County Natural Medicine|