Blepharospasm, Blepharospasm, Benign Essential, CBD
Conditions
Keywords
Cannabidiol, Epidiolex, Botulinum Toxin, Eyeblink analysis, Videorecording, Blepharospasm, BEB
Brief summary
The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
Interventions
100 mg BID for three months Placebo oral solution for three months
Sponsors
Benign Essential Blepharospasm Research Foundation
GW Pharmaceuticals Ltd
Smith-Kettlewell Eye Research Institute
Silkiss Eye Surgery
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients in the private practice of the principal investigator with an ICD code of blepharospasm and: * undergoing routine maximal botulinum therapy * experiencing break through symptoms of spasm * marijuana naïve
Exclusion criteria
* concomitant diagnosis of epilepsy * patients whom are not marijuana naive * patients on concurrent anti-epileptics * patients who are pregnant or wishing to become pregnant * patients not wishing to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eyeblink analysis from high speed videocamera recordings - see separate outcome measures | 4 measurements over 6 months | All patients will undergo video recording of their eyelid kinematics at days 0, 45, 90, 135, and 180. A high-resolution commercially available video camera will capture the eyelid positions at a sampling rate of thirty frames per second. Patients will be assessed in three different lighting conditions - in regular exam room lighting, under examination with the glare source of an indirect ophthalmoscope (at 2000 lux on both eyes from 5 feet), and in dim lighting. The upper and lower eyelid positions captured from each frame of the videos will be input into custom software developed by Visage Technologies, which fits a feature template to the facial features in each frame, including the upper and lower lids of each eye. The difference between the upper and lower lid positions defined the lid aperture, also known as the palpebral fissure. The eyeblink parameters will then calculated from the eyelid aperture time series with custom software written in MATLAB. |
| Median Blink Amplitude | 4 measurements over 6 months | Measured in millimeters (mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Blink Duration | 4 measurements over 6 months | Measured in milliseconds (ms) |
| Median Max Blink Velocity | 4 measurements over 6 months | Measured in millimeters per milliseconds (mm/ms) |
| Number of Blinks per 100ms | 4 measurements over 6 months | Total blinks in 100 milliseconds (numeric value) |
Countries
United States
Outcome results
None listed