Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation (ITHNCLR)

• ClinicalTrials.gov Identifier: NCT04284449
• Recruitment Status: Recruiting
• First Posted: February 25, 2020
• Last Update Posted: March 24, 2023
• Sponsor: National University of Natural Medicine
• Collaborator: North County Natural Medicine
• Information provided by (Responsible Party): Ryan Bradley, National University of Natural Medicine

Tracking Information

• First Submitted Date: February 12, 2020
• First Posted Date: February 25, 2020
• Last Update Posted Date: March 24, 2023
• Actual Study Start Date: February 24, 2020
• Actual Primary Completion Date: February 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 21, 2020)

• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 21, 2020)

• 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)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
• Official Title: Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Healthy adults aged 60 years or more, with objectively measurable cognitive impairment, who volunteer to receive care at a specific clinic in Southern California.
• Condition: Cognitive Dysfunction

Intervention

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.

Study Groups/Cohorts

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.

Intervention: Other: Whole-practice cognitive optimization

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 21, 2020): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2023
• Actual Primary Completion Date: February 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Ryan Bradley, ND; 503.552.1804; rbradley@nunm.edu

Contact: John Phipps, PhD; 503.552.1763; jphipps@nunm.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04284449
• Other Study ID Numbers: RB7102019
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ryan Bradley, National University of Natural Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: National University of Natural Medicine
• Original Study Sponsor: Same as current
• Collaborators: North County Natural Medicine

Investigators

• Principal Investigator: Ryan Bradley, ND; National University of Natural Medicine
• Principal Investigator: Heather Sandison, ND; North County Natural Medicine

• PRS Account: National University of Natural Medicine
• Verification Date: March 2023