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Completed

NCT Number: NCT04284449

Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation

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.

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Key information

Conditions

Cognitive Dysfunction Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

North County Natural Medicine

Encinitas, California, 92024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Community-dwelling adults ≥60 years of age.
  • Montreal Cognitive Assessment (MoCA) score of 12-23.
  • 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 >23.
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. NIH Toolbox-Cognitive Battery

    Time frame: Baseline, 6 months

    Change from baseline to 6 months in scores on a computer-administered cognitive function test

  2. 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

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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)

Sponsors and collaborators

Lead sponsor

National University of Natural Medicine

Other

Collaborators

  • North County Natural Medicine

Registry information

Acronym: ITHNCLR

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2020
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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