The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Holter SDNN Parameter Change
Study Overview
Brief Summary
The investigators propose to study the effects of cannabidiol (CBD) on cardiac electrical function and the autonomic nervous system in children with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS), when the CBD is administered as an artisanal oil obtained through state dispensaries or other sources. The intent is to begin to assess potential risks and benefits of this therapy in a vulnerable patient population by characterizing the effects of CBD on EKG findings, heart rate variability and the occurrence of seizures.
Detailed Description
Specific Aims/Study Objectives
This is a pilot study to explore the effects of cannabidiol (CBD) on autonomic cardiac function in children with Dravet syndrome (DS) or Lennox-Gastaut syndrome (LGS) when the CBD is administered as an artisanal oil. This will be achieved by addressing the following specific aims.
Aim #1: To determine the effects of CBD on cardiac function in 30 children with DS and LGS. This is the primary aim of the study: The effects of CBD on the cardiac function of 30 children with DS or LGS will be assessed using a 15-lead electrocardiogram (EKG) and a 24-hour Holter monitor. Investigators hypothesize that there will be no alterations in ventricular repolarization and heart rate variability on the EKG and Holter monitoring, respectively, after taking CBD for 4-8 weeks, compared to when participants were not taking CBD.
Note: The following aims are secondary to the primary outcome and goal of assessing the effects of CBD on cardiac function.
Aim #2: To assess signs and symptoms of dysautonomia in the presence and absence of CBD. Signs and symptoms of dysautonomia include parental perception of body temperature, skin color in hands and feet, sweating, pupil size, flushing, feeding issues, heart rate, strong emotions, constipation, urination or bowel movement issues, and irritability. These signs and symptoms will be collected using a previously-established dysautonomia survey. Investigators hypothesize there will be no change in qualitative assessments of signs and symptoms of dysautonomia after taking CBD for 4-8 weeks, compared to when participants were not taking CBD.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with Dravet syndrome or Lennox-Gastaut syndrome
- •Patients who are planning to obtain medical cannabidiol
- •Patients who are already taking medical cannabidiol and are planning to stop taking it
Exclusion Criteria
- •Patients without a diagnosis of Dravet syndrome or Lennox-Gastaut syndrome
Arms & Interventions
Heart Function and Dysautonomia
This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.
Intervention: 12-Lead ECG (Procedure)
Heart Function and Dysautonomia
This study looks at participants already receiving CBD from the state of MN. We are not providing the CBD. We are looking at heart function with ECGs and Holter monitoring before and after CBD is taken by the participant. We are also looking at dysautonomia signs and symptoms and seizure frequency before and after CBD is taken by the participant.
Intervention: Cannabidiol (Drug)
Outcomes
Primary Outcomes
Holter SDNN Parameter Change
Time Frame: Baseline to 4 to 8 week follow up visit
Change from baseline Holter SDNN parameter to follow up visit Holter SDNN parameter.
Secondary Outcomes
- Dysautonomia Signs and Symptoms(Baseline and 4 to 8 week follow up visit)
- Seizure Frequency(Baseline and 4 to 8 week follow up visit)