Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm
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.
|Condition or disease||Intervention/treatment||Phase|
|Blepharospasm Blepharospasm, Benign Essential CBD||Drug: Cannabidiol Oral Solution [Epidiolex]||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm – a Prospective Double-masked Cross-over Study|
|Actual Study Start Date :||May 20, 2020|
|Actual Primary Completion Date :||March 22, 2021|
|Actual Study Completion Date :||October 1, 2021|
Eyeblink analysis from high speed videocamera recordings – see separate outcome measures [ Time Frame: 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 Duration [ Time Frame: 4 measurements over 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Cannabis Therapy for Dystonia [Does It Work?]
Dystonia is a general term that doctors use to describe a group of movement disorders. These conditions involve uncontrollable muscle spasms and sometimes pain. They can have a massive impact on the sufferer’s quality of life, but treatment options are limited.
With medical marijuana and CBD becoming more popular, some patients are wondering whether cannabis therapy can help dystonia. We investigate in this in-depth article. But, first, let’s take a closer look at dystonia and its symptoms.
What Is Dystonia?
The term dystonia describes any one of several conditions that affect the muscles and movement. It results in uncontrollable muscle spasms and cramps, which can be extremely painful.
There are many different subtypes of dystonia, each affecting a different part of the body. They include the following:
- Generalized dystonia (affects the whole body)
- Myoclonus dystonia (jerking that typically affects the arms, torso, and neck)
- Cervical dystonia (only affects the neck)
- Blepharospasm (affects the eyes)
- Laryngeal dystonia (affects the larynx)
- Oromandibular dystonia (affects the lower face, jaw, and tongue)
Some types of dystonia are ‘task-specific,’ meaning that they only occur when carrying out certain activities. These activities might include writing, typing, or playing a musical instrument.
In the early stages, dystonia symptoms are often mild. They may only occur in an isolated body part when performing a specific activity.
Eventually, these symptoms may progress to other body parts and become present most of the time. However, this is not always the case. Some people find that their dystonia either plateaus or improves over time.
How and when to use CBD Oil…
The most common symptoms of dystonia include:
- Unusual twisting of the affected body part
- Slow, repetitive movements
- Muscle spasms and cramping
- Uncontrollable blinking
Dystonia symptoms can occur for the first time at any age. Most types of dystonia are more common in women than in men.
What Causes Dystonia?
Most experts agree that dystonia results from an abnormality in one of the brain regions responsible for movement.
For example, the basal ganglia control voluntary muscle and eye movements, among other things. This region of the brain is often dysfunctional in patients with dystonia, although other areas may also be involved.
Dystonia also appears to have a potential link with certain neurotransmitters, such as dopamine and gamma-aminobutyric acid (GABA). When the brain is unable to process these neurotransmitters effectively, their messages can become jumbled, which may lead to abnormal movement.
Most experts agree that dystonia results from an abnormality in one of the brain regions responsible for movement.
Doctors generally classify dystonia into one of three categories:
- Idiopathic dystonia: This type of dystonia has no apparent cause.
- Genetic dystonia: Mutations in a specific gene cause a variety of dystonia that runs in families.
- Acquired dystonia: A kind of dystonia that occurs due to brain injury (stroke, oxygen deprivation, or physical trauma) as well as certain medications.
Dystonia often appears in tandem with other medical conditions, including Parkinson’s disease, multiple sclerosis, and cerebral palsy. Moreover, there are several dystonia triggers that can exacerbate symptoms. These include:
- Activities such as talking, chewing, writing, typing, etc.
Common Dystonia Treatments (Not Cannabis)
Unfortunately, there is no cure for dystonia yet. However, there are several treatments that may help patients to manage their symptoms:
- Botulinum toxin (Botox) injections
- Muscle relaxants
- Physical or occupational therapy
- Deep brain stimulation
Deep brain stimulation involves placing a battery in the chest or abdomen. It is connected to the brain via thin wires and provides electrical stimulation to specific areas of the brain. For some patients, it can give relief from symptoms. However, others derive minimal benefit.
With dystonia treatment options so limited, it is little wonder that some patients are turning to cannabis. But does it really help?
Does Cannabis Help Dystonia?
Cannabis therapy has become widely accepted in recent years. The majority of American states now have medical marijuana programs in place, and some even allow recreational use.
Furthermore, new research is continually shedding light on the myriad benefits of the plant. To date, most studies have focused on THC and CBD, the two most prominent cannabinoids.
THC is probably best known for its intoxicating effects but also possesses a wealth of medicinal uses. On the other hand, CBD is famous for providing many similar benefits to THC but without the high.
So far, research into cannabis for dystonia has yielded somewhat mixed results. According to a 2015 study for the journal Neurotherapeutics, there have been several reports of marijuana helping patients with dystonia. However, these are mostly single case reports, and large-scale clinical trials are lacking.
One 2002 study assessed the effects of nabilone (a synthetic form of THC) for dystonia. It found that there were no significant improvements in subjects.
Research into CBD for dystonia is slightly more promising. A 2002 study for the European Journal of Pharmacology tested CBD on hamsters with idiopathic dystonia. They found that high doses tended to delay the progression of the disease.
Another study for The International Journal of Neuroscience followed five patients with dystonic movement disorders. The participants took CBD doses between 100mg and 600mg daily for a total of six weeks.
Amazingly, all of the patients experienced improvements, ranging between 20% and 50%. However, two patients with Parkinson’s features found that doses over 300mg exacerbated their symptoms.
CBD Effects on Dystonia
The most likely explanation for CBD’s effects on dystonia is its interaction with the endocannabinoid system (ECS). This system is present in most of the body’s tissues, including the brain.
The ECS is composed of cell receptors called cannabinoid receptors (CB1 and CB2) and chemicals called endocannabinoids. These two components bind together like a lock and key to regulate a range of physiological functions. The ECS is involved in mood, appetite, and immunity, among other things.
CBD works by slowing the breakdown of endocannabinoids, thus increasing their levels in the brain.
The ECS also plays a crucial role in motor function. There is an exceptionally high concentration of CB1 and CB2 receptors in the basal ganglia of the brain. Experts have hypothesized that this is where CBD exerts its effects on dystonia.
CBD works by slowing the breakdown of endocannabinoids, thus increasing their levels in the brain. Furthermore, CBD has potent antioxidant and anti-inflammatory effects. These benefits mean that it could help to protect structures in the brain from damage in conditions like Parkinson’s disease.
However, more research is necessary to confirm how well CBD works for dystonia.
What Is the Best CBD for Dystonia?
If an individual decides to try CBD for dystonia, there are a few things to bear in mind.
If a person lives somewhere where medical marijuana is legal and has a qualifying condition, they can apply for an MMJ card. This card allows its holders to purchase high-CBD cannabis strains or CBD oil from licensed dispensaries.
The advantage of this is that it allows people to choose a product containing some THC alongside its CBD and benefit from both cannabinoids.
However, if a person lives somewhere without a medical marijuana program, they are limited to buying hemp-derived CBD oil. This product contains just trace amounts of THC and is, therefore, legal in the majority of places.
Revealing the truth…
Hemp-derived CBD is also an excellent option for anyone who does not want to deal with the intoxicating effects of THC.
The problem with many CBD products is that the market is not well-regulated. Therefore, a lot of companies are selling items that are not up to scratch. Some contain far less CBD than they should, while others could include contaminants like pesticides or solvents.
Therefore, people should be cautious when buying CBD oil for dystonia. Look for a brand that offers third-party lab reports on its website. These reports show exactly what is in each product and prove there is nothing to hide.
There are also a huge variety of different CBD products to choose from, and picking one can be confusing. For more guidance on purchasing CBD, check out our guide to the best types of CBD products.
Cannabis Therapy for Dystonia: Final Thoughts
Dystonia is a condition that has a severe impact on a person’s quality of life. It can cause not only severe pain but also makes everyday activities a challenge. Furthermore, there are few truly effective treatments available.
Therefore, many people are turning to cannabis therapy for dystonia. There have been reports over the years of this natural medicine relieving dystonia symptoms for some people. However, hard clinical evidence is lacking, so there is no guarantee that it will work for everyone.
If a person is thinking about trying cannabis or CBD oil for dystonia, consult a medical professional first. They will advise whether it is safe or not and offer additional advice on how to manage one’s symptoms.