CBD Oil And Cerebral Palsy

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Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy (HemPhar) The proposed study is a double-blind, placebo-controlled, cross over study on Medical marijuana has recently become a hot-button issue in America. Many people tout the medical benefits of marijuana and CBD oil with regard to cerebral palsy and/or seizures, but is it right for my child?

Full-spectrum Medical Cannabis for Treatment of Spasticity in Patients With Severe Forms of Cerebral Palsy (HemPhar)

The proposed study is a double-blind, placebo-controlled, cross over study on 60 children aged 5 to 25 years with severe spasticity related to cerebral palsy (CP), level IV and V with full-spectrum medical cannabis product of CBD/THC ratio 10:1.

Condition or disease Intervention/treatment Phase
Children, Adult Spastic Cerebral Palsy Quality of Life Cannabis Physical Disability Diagnostic Test: Lab tests Diagnostic Test: ECG Diagnostic Test: Cannabinoid Levels Drug: Full-spectrum Medical Canabis Product (HemPhar) Drug: Placebo Diagnostic Test: Spasticity level according to modified Ashworth scale (Bohannon) Diagnostic Test: Gross Motor Function Measure Diagnostic Test: Borg rating of perceived exertion scale Diagnostic Test: Edmonton symptom assessment system Not Applicable

A) Active: Full-spectrum medical cannabis with ratio of CBD:THC 10:1 (HemPhar)

B) Placebo (both of the same producer)

  1. Informed consent should be signed by parents/caregivers.
  2. Weight of the participant should be determined and an IV line inserted. The following lab tests should be performed: CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea & creatinine, liver enzymes (AST, ALT, gGT)
  3. ECG performed and analyzed
  4. A trained physiotherapist will perform the following motor assessments: spasticity level according to modified Ashworth scale (Bohannon), function/activity assessment with the use of Gross Motor Function Measure scale (GMFM-88) and assessment of muscle power with dynamometer.
  5. Randomization of patients into one of the two arms of the study
  6. Active substance or placebo are introduced thereafter (as an oral oily solution for oral application) in a starting dose of 0.08 mg/kg body weight (BWt)/day divided in 2 doses (the dose is according to the THC content). The dose is gradually increased, every 3 days for 0.08 mg THC/ kg BWt/day, until the maximum dose of 1 mg THC/kg BWt/day is reached, or else until adverse effects are noted. It is expected that the average dose will be 0.33 mg/kg BWt per day.
  7. The parents/caregivers are given questionnaires/scales and also given oral instructions on how to fulfil them (Edmonton scale, Borg scale and Global Impression of Change – GIC) and the paper to take down notes on possible side/adverse effects while taking the preparation (either active substance or placebo).
  8. After 6 weeks of taking the substance or at the premature end of the study again the lab tests will be performed as well as the motor assessment by the physiotherapist (as above at inclusion).
  9. In patients, who have been receiving placebo for the first 6 weeks, the active substance is given for the next 6 weeks, as described above (under 6). The patients who have been receiving the active substance for the first 6 weeks will continue to do so for the next 6 weeks.
  10. Additional blood samples are taken at 6 weeks in both groups for analysis of levels of cannabidiol (CBD) as well as delta-9-tetrahydrocannbinol (THC) – around 4 ml of blood for determination of both levels at time(s) after ingestion: 0, 1, 2, 4, 8 and 24 hours.

At the end of the study (after 12 weeks) again repeat:

  1. CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea & creatinine, liver enzymes (AST, ALT, gGT)
  2. ECG
  3. Motor assessments by a physiotherapist (Ashworth/Bohannon, GMFM 88, dynamometer)
  4. Pharmacokinetics: 4 ml of blood for determination of phamacokinetics after ingestion of the last dose (as in point 10 above)

NOTE: if severe side/adverse effects are noted, the test compound should be stopped immediately. If mild/moderate side/adverse effects are noted, the test component should be gradually stopped: for 0,08 mg/kg BWt/day, every 3 days.

Active substance: Full-spectrum medical cannabis product of CBD/THC ratio 10:1.

Arm 1: Active substance. The starting dose will be 0,08 mg THC per kilo body weight daily in 2 divided doses which will gradually be increased (escalating dose of 0,08 mg THC kg/d) until maximal dose of 1 mg/kg/d.

Crossover: After 6 weeks Arm 2 will also receive the active substance and patients in both arms will continue receiving the active substance for the next 6 weeks.

For research purposes the investigators will use a preparation in the form of drops, containing full-spectrum medical cannabis extract (HemPhar) with THC:CBD ratio 1:10, and other cannabinoids as well, provided by Pharmahemp, GMP-certified medical cannabis producer.

CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea & creatinine, liver enzymes (AST, ALT, gGT)

Determination of levels of cannabidiol (CBD) and delta-9-tetrahydrocannbinol (THC) for determination of levels at following time(s) after ingestion: 0, 1, 2, 4, 8 and 24 hours.

A trained physiotherapist will assess spasticity level according to modified Ashworth scale (Bohannon), which is 6-level scale for assessment of spasticity.

Modified Ashworth/Bohannon Scoring Scale (Bohannon and Smith, 1987):

0 No increase in muscle tone

  1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM )
  2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
  3. Considerable increase in muscle tone, passive movement difficult
  4. Affected part(s) rigid in flexion or extension

Best score is 0 (no spasticity), worst score is 4 (severe spasticity).

A trained physiotherapist will assess Gross Motor Function Measure (GMFM-88) which is commonly used in the evaluation of gross motor function in children with cerebral palsy

The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument developed to measure change in gross motor function over time. The test consists of 88 items categorized in five dimensions (Dimension A: lying and rolling, Dimension B: sitting, Dimension C: crawling and kneeling, Dimension D: standing and Dimension E: walking, running and jumping). The test was conducted as described in the GMFM-88 manual . A percentage score as compared to maximum is calculated for each dimension and for the total score of the five dimensions.

Reference curves exist for GMFM-88 for each age group.

Floor score is 4 (minimum score / worst), ceiling score (maximum score / best) is 75.

Edmonton symptom assessment system and general impression scale (1 – very much improved; 7 – very much worse).

For research purposes the investigators will use a placebo in the form of drops, containing oil only, provided by Pharmahemp, GMP-certified medical cannabis producer.

CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea & creatinine, liver enzymes (AST, ALT, gGT)

A trained physiotherapist will assess spasticity level according to modified Ashworth scale (Bohannon), which is 6-level scale for assessment of spasticity.

Modified Ashworth/Bohannon Scoring Scale (Bohannon and Smith, 1987):

0 No increase in muscle tone

  1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM )
  2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
  3. Considerable increase in muscle tone, passive movement difficult
  4. Affected part(s) rigid in flexion or extension

Best score is 0 (no spasticity), worst score is 4 (severe spasticity).

A trained physiotherapist will assess Gross Motor Function Measure (GMFM-88) which is commonly used in the evaluation of gross motor function in children with cerebral palsy

The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument developed to measure change in gross motor function over time. The test consists of 88 items categorized in five dimensions (Dimension A: lying and rolling, Dimension B: sitting, Dimension C: crawling and kneeling, Dimension D: standing and Dimension E: walking, running and jumping). The test was conducted as described in the GMFM-88 manual . A percentage score as compared to maximum is calculated for each dimension and for the total score of the five dimensions.

Reference curves exist for GMFM-88 for each age group.

Floor score is 4 (minimum score / worst), ceiling score (maximum score / best) is 75.

Edmonton symptom assessment system and general impression scale (1 – very much improved; 7 – very much worse).

    Effect on spasticity (6w; FSMC vs placebo) [ Time Frame: 6 weeks ]

A trained physiotherapist will assess spasticity level according to modified Ashworth scale (Bohannon), which is 6-level scale for assessment of spasticity.

Modified Ashworth/Bohannon Scoring Scale (Bohannon and Smith, 1987):

0 No increase in muscle tone

  1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM )
  2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
  3. Considerable increase in muscle tone, passive movement difficult
  4. Affected part(s) rigid in flexion or extension

Best score is 0 (no spasticity), worst score is 4 (severe spasticity).

A trained physiotherapist will assess Gross Motor Function Measure (GMFM-88) which is commonly used in the evaluation of gross motor function in children with cerebral palsy

The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument developed to measure change in gross motor function over time. The test consists of 88 items categorized in five dimensions (Dimension A: lying and rolling, Dimension B: sitting, Dimension C: crawling and kneeling, Dimension D: standing and Dimension E: walking, running and jumping). The test was conducted as described in the GMFM-88 manual . A percentage score as compared to maximum is calculated for each dimension and for the total score of the five dimensions.

Reference curves exist for GMFM-88 for each age group.

Floor score is 4 (minimum score / worst), ceiling score (maximum score / best) is 75.

A trained physiotherapist will assess spasticity level according to modified Ashworth scale (Bohannon), which is 6-level scale for assessment of spasticity

Modified Ashworth/Bohannon Scoring Scale (Bohannon and Smith, 1987):

0 No increase in muscle tone

  1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM )
  2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
  3. Considerable increase in muscle tone, passive movement difficult
  4. Affected part(s) rigid in flexion or extension

Best score is 0 (no spasticity), worst score is 4 (severe spasticity).

A trained physiotherapist will assess Gross Motor Function Measure (GMFM-88) which is commonly used in the evaluation of gross motor function in children with cerebral palsy.

The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument developed to measure change in gross motor function over time. The test consists of 88 items categorized in five dimensions (Dimension A: lying and rolling, Dimension B: sitting, Dimension C: crawling and kneeling, Dimension D: standing and Dimension E: walking, running and jumping). The test was conducted as described in the GMFM-88 manual . A percentage score as compared to maximum is calculated for each dimension and for the total score of the five dimensions.

Reference curves exist for GMFM-88 for each age group.

Floor score is 4 (minimum score / worst), ceiling score (maximum score / best) is 75.

Can Marijuana Help Kids with Cerebral Palsy?

Medical marijuana has recently become a hot-button issue in America. Many people tout the medical benefits of marijuana and CBD oil with regard to cerebral palsy and/or seizures, but is it right for my child?

While there are medications, surgeries, and therapies aimed at helping individuals with cerebral palsy gain more control over their muscles, they may still face challenges with regard to seizures, mood, and more.

Some recent studies are now extolling the benefits of treating cerebral palsy with marijuana or cannabidiol (CBD) oil, a non-psychoactive constituent of marijuana.

Medical Marijuana

Marijuana was once seen as a recreational drug thought to have no medical benefits, but several recent studies on the plant have challenged this perception.

While there is still much controversy regarding whether or not the potential medical benefits outweigh any potential health risks, many families are desperate for any relief — especially when it comes to a child suffering from frequent seizures.

Although many states have recently legalized medical marijuana, it is still illegal to possess the plant (or any derivative) in several states. Even in states which do allow medicinal use, it’s only allowed with a doctor’s recommendation, and is still technically illegal to posses under federal law.

Marijuana is thought to have two main active compounds with medicinal properties: THC and CBD. Tetrahydrocannabinol (THC) is the psychoactive compound most-commonly associated with “getting high,” while cannabidiol (CBD) is a non-psychoactive compound generally associated with downregulation and anti-anxiety.

Because THC can impair cognitive function, it is generally not recommended for use on children except in rare circumstances. On the other hand, children with cerebral palsy may benefit from CBD oil in a number of ways.

While many families have an understandable fear of potential legal consequences, in many cases, their number one concern is the health and well-being of their child. If you have questions or are considering this treatment option, speak to your child’s doctor.

CBD and Cerebral Palsy Symptoms

CBD Used to Combat Seizures

Between 35-50 percent of children with cerebral palsy develop seizure disorders. Recent studies have shown that CBD oil can dramatically reduce the number of seizures in some patients due to its anti-epileptic properties, and there have been several anecdotal reports from families who have had success with this form of treatment.

Treating Spasticity with CBD

CBD is a phytochemical that is found in higher quantities in some cannabis strains. That being said, it can be isolated and expressed in oil, which can be found in almost all marijuana dispensaries across the country. CBD is known as a muscle relaxant, mood enhancer, gamma-aminobutyric acid (GABA) booster, and is thought to increases levels of chemicals that inhibit the over-expression of nerve impulses in the brain and body. CBD may therefore be useful for individuals with spastic cerebral palsy who may have a problem with stiff muscles and spastic movements.

CBD for Chronic Pain Relief

CBD oil can also be helpful in individuals with cerebral palsy who may be suffering from chronic muscle and joint pain due to not being able to fully extend their limbs. CBD oil has been shown to have pain-relieving properties by boosting levels of serotonin, which is a chemical responsible for the perception of pain and tempering down of inflammation.

CBD oil may also address issues such as insomnia or sleep disturbances (due to promoting the release of melatonin), mood or depression, difficulty with speech, and even constipation.

As with any type of medical treatment, you should always speak to your child’s doctor about the potential risks and benefits. Marijuana may show promise, but it is not always recommended unless other treatment options are ineffective or insufficient — especially when it comes to young children.

4 Comments

Hi, I live in Ireland, and I have triplets, 12 years old, and one of my daughters have a mild cerebral palsy, with spasticity in her legs. Now, she is in puberty and she is complaining about the pain in her legs, joints, knees, and she is walking worse, I believe her body is trying to streech because the puberty , I would like to know how the CBD can help her? CBD oil is available in Ireland, but I dont know whats the best for her: oil, cream, tablets?? Can you guide me please? I really need to help her! Also she is having panic attack and anxiety episodes.
Thansk a milion
Claudia Aguiar

Claudia, a dear friend of mine has been helping people with several conditions including Cerebral palsy. Please check him on instagram – ladstalkhealth , his name is James and he is truly an angel

Hi I have a 15year old son whiit cp would Marijuana help my son

Hi. I live in Tennessee and have cerebal palsy. How can I get medical marijuana?

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