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Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury

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ClinicalTrials.gov Identifier: NCT03826368
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Collaborators:
Flowering HOPE Foundation
Clover Leaf University
Information provided by (Responsible Party):
Donald Cooper Ph.D., Real Time Diagnostics Ventures INC

Brief Summary:
The objective of the proposed research is to evaluate adult subjects currently taking phytocannabinoid Hemp-derived botanical supplements (HDS) during recovery from traumatic brain injury. This study seeks to answer whether subjects taking HDS formulations experience relief from self-reported symptoms or improved subjective well-being, sleep quality, cognitive benefits, side effects and/or quantifiable changes in brain state neuronal activity or stress biomarkers. We seek to answer whether regular users (once/week to multiple uses/day) of HDS experience signs of dependence, addiction or physiological withdrawal. To accomplish this we will use survey questions, quantitative EEG, cognitive testing and salivary biomarkers to determine the effectiveness of self-initiated HDS administration. In addition, we are interested in whether our objective measures allow us to understand why some people are responders to HDS health benefits while others are not.

Condition or disease Intervention/treatment
Traumatic Brain Injury Dietary Supplement: Hemp-derived botanical dietary supplement

Detailed Description:
Subjects located in Colorado will be asked to complete the Patients' Global Impression of Change (PGIC) symptom inventory and Pittsburgh Sleep Quality Index (PSQI) before EEG testing and SA testing. On the test day prior to administration of their ongoing Hemp-derived supplementation, the clinical research coordinator will provide the tablets survey and saliva collection kits to gather saliva from mouth swabs and test for SA and basal THC using a rapid test. Active EEG measurements will be gathered from subjects during a cognitive loading task. Heart rate and pulse oxygen is monitored. Subject will have headphones placed around their ears and a variety of tones delivered at a range of frequencies between 1-400 Hz at a comfortable decibel level will be played and they will be asked to indicate when the tone changes or if the tone is in sync with a flashing light. During this task EEG will be monitored and stored with memory performance. After testing a second saliva sample will be collected for testing to determine a relationship between salivary biomarkers of Cannabinoid function or THC are correlated with symptom survey or EEG results

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury
Actual Study Start Date : January 18, 2019
Estimated Primary Completion Date : January 16, 2020
Estimated Study Completion Date : January 16, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
TBI Controls
Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals.
Dietary Supplement: Hemp-derived botanical dietary supplement
Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.
Other Names:
  • Cannabidiol
  • CBD

TBI HDS
Adult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals.
Dietary Supplement: Hemp-derived botanical dietary supplement
Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.
Other Names:
  • Cannabidiol
  • CBD




Primary Outcome Measures :
  1. Symptom inventory [ Time Frame: Subjects complete the symptom inventory within 30 minutes of arriving to testing facility after signing the consent forms. ]
    Sleep and broad symptom inventory

  2. qEEG frequency, brain region coherence assessment baseline measured once immediately after completion of symptom inventory at the testing facility. [ Time Frame: Subjects are assessed once immediately after completion of the symptom inventory lasting approximately 10 minutes. ]
    Frequency power spectral analysis, coherence at baseline in control subjects and treatment group subjects.

  3. qEEG frequency, brain region coherence assessment, pedaling RPM change measured during a 30-40 minute window after baseline testing. [ Time Frame: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes. ]
    Frequency power spectral analysis, coherence before and after peddling and during memory task where the subject is asked to name or spell the months of the year backwards while pedaling and EEG measurements are taken. Auditory tones are delivered via headsets and the subject is asked to report changes when they detect a change in frequency while attending to a blinking screen.

  4. Salivary Amylase changes [ Time Frame: 30 minute- 2 hrs post supplementation. ]
    Changes in salivary amylase associated with Hemp supplementation dose and time


Secondary Outcome Measures :
  1. Salivary Amylase changes from baseline in response to cognitive load testing [ Time Frame: 30 min after beginning of cognitive testing. ]
    Changes in salivary amylase associated with qEEG/cognitive testing

  2. Subject Accuracy during memory task [ Time Frame: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes. ]
    Subjects are asked to spell the name of the months or weeks backwards while pedaling a stationary bicycle.


Biospecimen Retention:   Samples Without DNA
Saliva swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy adults with a history of brain injury and experience taking hemp-derived phytocannabinoid hemp supplements during the recovery period. Controls without brain injury and experience with hemp supplements.
Criteria

Inclusion Criteria: Adult male or female volunteers between the ages of 18-55 who have experience a head trauma/ concussion resulting in the diagnosis of mild to moderate TBI (Glasgow Coma scale score between 9-14) with less than 30 minutes of unconsciousness and post-traumatic amnesia lasting less than 24 hours more than 1 month ago will be considered for participation in the study. Volunteers must be able to move about the community of the Denver metro area and speak fluent English. They must be able to leisurely ride a stationary recumbent bicycle without assistance for 10 minutes and sit stationary for 15 minutes without discomfort. They must be familiar with the brand and dosing of HDS and been regular users, defined as once /week up to multiple uses per day for at least 1 month in the past year. They must be able to hear a 25 decibels in at least one ear and respond verbally to questions while remaining still.

Exclusion Criteria:

Medications. Most subjects may continue to take medications for other conditions. However, subjects should be on stable doses of these medications for a specified period prior to beginning the study. A stable dose means that there have been no changes in the drug dosage during the past 2 months.

Subjects may not be current users of illegal drugs (e.g., cocaine, methamphetamine) Subjects may not have an immune-relevant disease (e.g. HIV, MS, Lyme Disease) Females may be pregnant or lactating and taking HDS supplementation. In the consent form we will include a warning that taking cannabis related products during pregnancy or while nursing could pose a danger to the development of the infant.

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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): NCT03826368


Contacts
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Contact: Donald C Cooper, Ph.D. 720 431 3495 don.cooper@rtdx.io
Contact: Claire Overturf 303 408 1433 claire.d.overturf@gmail.com

Locations
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United States, Colorado
Flowering HOPE Foundation/Clover Leaf University Recruiting
Denver, Colorado, United States, 80229
Contact: Donald C Cooper, Ph.D.    720-431-3495    don.cooper@rtdx.io   
Principal Investigator: Donald C Cooper, Ph.D.         
Sponsors and Collaborators
Real Time Diagnostics Ventures INC
Flowering HOPE Foundation
Clover Leaf University

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Responsible Party: Donald Cooper Ph.D., Principal Investigator, Real Time Diagnostics Ventures INC
ClinicalTrials.gov Identifier: NCT03826368     History of Changes
Other Study ID Numbers: 2018/07/17
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Donald Cooper Ph.D., Real Time Diagnostics Ventures INC:
Cannabinoid
CBD
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System