Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation

Cognitive Dysfunction Clinical Trial

— ITHNCLR  

Official title:

Integrative Therapy for Holistic, Natural Cognition and Lifestyle Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284449
• Other study ID #: RB7102019
• Status: Recruiting
• Start date: February 24, 2020
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: National University of Natural Medicine
• Contact: Ryan Bradley, ND
• Phone: 503.552.1804
• Email: rbradley[@]nunm.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
United States	North County Natural Medicine	Encinitas	California

Sponsors (2)

Lead Sponsor	Collaborator
National University of Natural Medicine	North County Natural Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIH Toolbox-Cognitive Battery	Change from baseline to 6 months in scores on a computer-administered cognitive function test	Baseline, 6 months
Primary	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
Secondary	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
Secondary	Peak alpha frequency	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
Secondary	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
Secondary	Sleep quantity	Change from baseline to 6 months in participants' total sleep as measured with telemetry from a wrist-worn activity tracker	6 months
Secondary	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