Traumatic Brain InjuryNCT03826368
Hemp-Derived Botanical Dietary Supplementation During Recovery From Brain Injury
An observational study of Traumatic Brain Injury, run by Real Time Diagnostics Ventures INC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Hemp-derived botanical dietary supplement
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Apr 2020to 13 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
None listed.
Who cannot join
- 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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About this study
Official title: Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury
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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Hemp-derived botanical dietary supplement
- Keywords
- Cannabinoid, CBD
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemp-derived botanical dietary supplementDietary supplement
Also called Cannabidiol, CBD
Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.
| Study group | Role | What they receive |
|---|---|---|
| TBI Controls | Adult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals. Receives: 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. Receives: Dietary Supplement: Hemp-derived botanical dietary supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom inventory
Sleep and broad symptom inventory
Measured: Subjects complete the symptom inventory within 30 minutes of arriving to testing facility after signing the consent forms.
qEEG frequency, brain region coherence assessment baseline measured once immediately after completion of symptom inventory at the testing facility.
Frequency power spectral analysis, coherence at baseline in control subjects and treatment group subjects.
Measured: Subjects are assessed once immediately after completion of the symptom inventory lasting approximately 10 minutes.
qEEG frequency, brain region coherence assessment, pedaling RPM change measured during a 30-40 minute window after baseline testing.
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.
Measured: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.
Secondary outcomes (1)
Subject Accuracy during memory task
Subjects are asked to spell the name of the months or weeks backwards while pedaling a stationary bicycle.
Measured: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start13 Apr 2020 (estimated)
- Primary completion13 Apr 2020 (estimated)
- Study completion13 Apr 2020
Why it stopped: Lack of initial funding after approval of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Time Diagnostics Ventures INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Donald Cooper Ph.D., Real Time Diagnostics Ventures INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826368
- Sponsor's protocol ID
- 2018/07/17
- Status last verified
- Apr 2020
- First submitted
- 29 Jan 2019
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemp-Derived Botanical Dietary Supplementation to Promote Healthy Brain Function During Recovery From Brain Injury
- ClinicalTrials.gov ID
- NCT03826368
- Acronym / sponsor ID
- 2018/07/17
- Conditions
- Traumatic Brain Injury
- Keywords
- Cannabinoid, CBD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of initial funding after approval of study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Real Time Diagnostics Ventures INCIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2020 (estimated)
- Primary completion
- 13 Apr 2020 (estimated)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Controls | – | Dietary Supplement: Hemp-derived botanical dietary supplementAdult men and women between 18 and 55. No prior history of traumatic brain injury. Experienced taking hemp-derived botanicals. |
| TBI HDS | – | Dietary Supplement: Hemp-derived botanical dietary supplementAdult men and women between 18 and 55. History of traumatic brain injury. Experienced taking hemp-derived botanicals. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemp-derived botanical dietary supplementAlso: Cannabidiol, CBDSubjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury. | Dietary supplement | TBI Controls, TBI HDS |
Primary outcome
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.
1 secondary outcome
Subject Accuracy during memory task
Time frame: Subjects are assessed once immediately after baseline qEEG test for 30-40 minutes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Real Time Diagnostics Ventures INC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom inventory (time frame: Subjects complete the symptom inventory within 30 minutes of arriving to testing facility after signing the consent forms.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.