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Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826368
Recruitment Status : Withdrawn (Lack of initial funding after approval of study)
First Posted : February 1, 2019
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Donald Cooper Ph.D., Real Time Diagnostics Ventures INC

Tracking Information
First Submitted Date January 29, 2019
First Posted Date February 1, 2019
Last Update Posted Date April 15, 2020
Estimated Study Start Date April 13, 2020
Estimated Primary Completion Date April 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2020)
  • 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
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: January 30, 2019)
  • 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
  • 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.
  • 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.
  • Salivary Amylase changes [ Time Frame: 30 minute- 2 hrs post supplementation. ]
    Changes in salivary amylase associated with Hemp supplementation dose and time
Change History
Current Secondary Outcome Measures
 (submitted: April 13, 2020)
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.
Original Secondary Outcome Measures
 (submitted: January 30, 2019)
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury
Official Title Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Saliva swabs
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.
Condition Traumatic Brain Injury
Intervention 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
Study Groups/Cohorts
  • TBI Controls
    Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals.
    Intervention: Dietary Supplement: Hemp-derived botanical dietary supplement
  • TBI HDS
    Adult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals.
    Intervention: Dietary Supplement: Hemp-derived botanical dietary supplement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 13, 2020)
0
Original Estimated Enrollment
 (submitted: January 30, 2019)
40
Actual Study Completion Date April 13, 2020
Estimated Primary Completion Date April 13, 2020   (Final data collection date for primary outcome measure)
Eligibility 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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Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number NCT03826368
Other Study ID Numbers 2018/07/17
Has Data Monitoring Committee No
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
Responsible Party Donald Cooper Ph.D., Real Time Diagnostics Ventures INC
Study Sponsor Real Time Diagnostics Ventures INC
Collaborators Not Provided
Investigators Not Provided
PRS Account Real Time Diagnostics Ventures INC
Verification Date April 2020