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| Name | Class |
|---|---|
| North County Natural Medicine | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled Participants | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole-practice cognitive optimization | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| NIH Toolbox-Cognitive Battery | Change from baseline to 6 months in scores on a computer-administered cognitive function test | Baseline, 6 months |
| Quality of Life in Neurological Disorders questionnaire (Neuro-QoL) | 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 | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Event-related potential (P300) | Change from baseline to 6 months of an auditory event provoked change in electrical potential of the brain, measured noninvasively by electroencephalography (EEG) | 6 months post-baseline visit |
| Peak alpha frequency |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adults aged 60 years or more, with objectively measurable cognitive impairment, who volunteer to receive care at a specific clinic in Southern California.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Bradley, ND | National University of Natural Medicine | Principal Investigator |
| Heather Sandison, ND | North County Natural Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North County Natural Medicine | Encinitas | California | 92024 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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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)
| 6 months post-baseline visit |
| Physical activity | Change from baseline to 6 months in participants' overall physical activity as measured with telemetry from a wrist-worn activity tracker | 6 months |
| Sleep quantity | Change from baseline to 6 months in participants' total sleep as measured with telemetry from a wrist-worn activity tracker | 6 months |
| Number and type of Adverse Events | Total number of adverse events and serious adverse events (using NIH's Common Terminology Criteria for Adverse Events version 4.0) | From enrollment through study completion, a period of 6 months |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |