Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284449
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : July 24, 2020
Sponsor:
Collaborator:
North County Natural Medicine
Information provided by (Responsible Party):
Ryan Bradley, National University of Natural Medicine

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.

Condition or disease Intervention/treatment
Cognitive Dysfunction Other: Whole-practice cognitive optimization

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
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.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ryan Bradley, ND 503.552.1804 rbradley@nunm.edu
Contact: John Phipps, PhD 503.552.1763 jphipps@nunm.edu

Locations
Layout table for location information
United States, California
North County Natural Medicine Recruiting
Encinitas, California, United States, 92024
Sponsors and Collaborators
National University of Natural Medicine
North County Natural Medicine
Investigators
Layout table for investigator information
Principal Investigator: Ryan Bradley, ND National University of Natural Medicine
Principal Investigator: Heather Sandison, ND North County Natural Medicine
Layout table for additonal information
Responsible Party: Ryan Bradley, Primary Investigator, National University of Natural Medicine
ClinicalTrials.gov Identifier: NCT04284449    
Other Study ID Numbers: RB7102019
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Bradley, National University of Natural Medicine:
Mild Cognitive Impairment (MCI)
Cognitive Decline
Alzheimer's Disease (AD)
Dementia
Additional relevant MeSH terms:
Layout table for MeSH terms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders