The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in children with neurological Patients with dystonia who smoked medical cannabis vs those who consumed cannabis oil extract were more likely to report dystonia symptom improvement.
The Effects of Cannabis on Dystonia and Spasticity on Pediatric Patients
A clinical trial is planned to study the effects of cannabis on dystonia and spasticity in children with neurological diseases. The clinical trial will include 40 children divided into two groups: children with spasticity and dystonia due to cerebral palsy, and children with spasticity and dystonia due to genetic neurodegenerative diseases. Each group will be randomly divided into two arms and will receive Avidekel cannabis oil 6-to-1 ratio of CBD to THC or enriched Avidekel cannabis oil 20-to-1 ratio of CBD to THC. During the study, various variables will be collected including: medication intake, spasticity, dystonia score, pain scale, restlessness scale, quality of life measures, safety tests, side effects, and an addiction test. The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improve motor function, non-motor functions and quality of life.
|Condition or disease||Intervention/treatment||Phase|
|Spasticity Dystonia||Drug: Avidekel oil Drug: Enriched Avidekel oil||Phase 2|
The purpose of this study is to examine the effect of two cannabis oils containing the main cannabinoid Δ9 -THC and CBD ratio of 1 to 6 and 1 to 20 (respectively), on spastic movement disorder and dystonia.
40 children will be enrolled in this study and will be divided into 2 groups:
- Children with spasticity and dystonia due to cerebral palsy
- Children with spasticity and dystonia due to genetic neurodegenerative diseases
Each group will be randomly divided into two groups:
I. Active comparator: 6-to-1 ratio of CBD to THC oil II. Active comparator: 20-to-1 ratio of CBD to THC oil
During the study the following variables will be collected:
- Consumption of drugs medication intake
- Spasticity grade measured using the Modified Ashworth Scale
- Dystonia grade measured using the Barry Albright Dystonia Scale
- Patient’s subjective report about the severity of his/her spasticity and/or dystonia
- Pain scale
- Restlessness scale
- Quality of life measures: function, sleep, mood , appetite , weight
- Safety tests: liver function, renal function, blood tests (complete blood chemistry), blood pressure, pulse, ECG
- Side effects
- Addiction test
The purposes of the study:
- Efficiency – examining the effect of cannabis on dystonia and spasticity.
- Examining the most effective cannabinoid ratio for the relief of dystonia and spasticity. (Δ9 -THC and CBD ratio of 1 to 6 or 1 to 20, respectively).
- Examining the effect of cannabis on quality of life measures (such as medication intake, mood, appetite, sleep).
- Safety: examination of side effects and unwanted effects of cannabis and its limitations.
Research Hypothesis: The investigators hypothesize that cannabis consumption will reduce dystonia and spasticity symptoms in children with motor disability related to genetic neurodegenerative diseases and cerebral palsy and as a result improves motor function, non-motor function and quality of life.
Medical Cannabis Improves Dystonia Symptoms and Alleviates Pain
In a retrospective pilot study presented at MDS 2021, researchers assessed the effect of medical cannabis treatment on symptoms of dystonia and related pain.
The following article is part of conference coverage from the International Congress of Parkinson’s Disease and Movement Disorders (MDS) Virtual Annual Meeting. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from the MDS 2021 Virtual Annual Meeting.
Consumption of medical cannabis in adults with dystonia improves symptoms and alleviates related pain, according to study findings presented at the International Congress of Parkinson’s Disease and Movement Disorders Society (MDS) Virtual Congress 2021, held from September 17 to 22, 2021.
Previous research has found medical cannabis may help treat involuntary muscle contractions and reduce related pain in patients with dystonia by the activation of cannabinoid receptors in the basal ganglia that release γ-aminobutyric acid (GABA). This could potentially reduce severity and improve quality of life for patients with dystonia. From 2013, the Israeli Ministry of Health (MOH) has accepted the use of medical cannabis for symptomatic treatment in patients with movement disorders and related pain.
The current study aimed to assess the effect of medical cannabis on dystonia muscle activity and related pain in patients with an MOH-approved medical cannabis license.
Patients with dystonia (n=23) with an approved medical cannabis license from the MOH were contacted via telephone by researchers from the Tel Aviv University, Israel. Using a 5-point Likert scale, participants’ demographics, medical cannabis use, and treatment effects were assessed.
A total of 11 women and 12 men, with a mean age of 52.7 years, were included in the analysis. Dystonia etiologies were generalized (n=9), focal (n=6), segmental (n=5), hemidystonia (n=2), or multifocal (n=1) caused by Parkinson disease (n=6), monogenic variants (n=4), or unknown (n=13).
Participants indicated that they had been using medical cannabis for an average of 2.5±1.0 years. Medical cannabis was consumed at a mean dose of 22.6±20.1 grams per month and at a frequency of 3.3±4.3 times per day. The medical cannabis was composed of 10.6%±6.6% tetrahydrocannabinol (THC) and 8.0%±5.7% cannabidiol. Participants also indicated that they used cannabis oil extract (47.8%), smoked dried buds (43.5%), or both (8.7%).
The subjective, self-reported efficacy of medical cannabis for dystonia was 3.3/5, pain was 3.7/5, and quality of life was 3.6/5. The majority of participants (70%) also reported an improvement in sleep.
Participants who experienced more improvements to their dystonia reported using a higher THC dose than those who showed little improvement, with a positive correlation between THC dose and dystonia symptom improvement (R 2 =0.012).
Participants who smoked medical cannabis vs those who consumed the oil were more likely to report dystonia symptom improvement.
Adverse effects included dry mouth (65%), worsening mood (n=3), anxiety (n=2), anxiety with hallucinations (n=1), and suicidal ideation (n=1). Three participants stopped receiving treatment with medical cannabis due to inefficacy or adverse effects.
Study limitations included its small size and the inclusion of patients with differing dystonia symptoms, using uncontrolled dosing and administration methods. Therefore, these findings should be validated in a larger, controlled study.
“[Medical cannabis] seems to improve symptoms of dystonia and related pain. Higher daily dose of THC and smoking rather than sublingual oil are significantly more efficacious,” the researchers concluded.
Anis S, Faust-Socher A, Sverdlov D, et al. A real-life study of medical cannabis effect on adults with dystonia. Presented at: MDS Virtual Congress 2021; September 17-22, 2021. Poster 93.