Intrathecal baclofen therapy (ITB)
Intrathecal baclofen therapy (ITB) for spasticity
What is ITB?
Baclofen is a drug produced as a muscle relaxant. It has been used to relieve the stiffness caused by spasticity (tight and stiff muscle tone).
It can be successfully administered orally in a low dose. However, children with more severe spasticity will need a higher dose. High doses of oral Baclofen have many side-effects, including lethargy and loss of balance. With Intrathecal Baclofen Therapy (ITB), also known as Continuous Intrathecal Baclofen Infusion (CIBI), Baclofen is delivered directly into the spinal fluid by a pump that is implanted under the skin of the abdomen in an operation that lasts about two hours. The pump is the size of an ice hockey puck, but can be easily ‘housed' in the abdominal cavity. The pump then delivers a small amount of the Baclofen via a small tube which passes under the skin and into the back. A computer turns on the pump and the dose of Baclofen can be adjusted upward or downward, depending on the individual's response.
How does it work?
By putting the Baclofen directly into the intrathecal space, a fluid filled cavity surrounding the spinal cord, the drug can act much more effectively as a muscle relaxant and reduce spasticity in the lower limbs. The amount used is only a fraction of the oral dose and without the side-effects associated with the oral administration of the drug.
In the UK
The Medicines and Healthcare Products Regulatory Agency has granted a licence for this treatment in the UK. A relatively small number of children in the UK have undergone this treatment. Some centres offering this operation are: Queens Medical Centre, Nottingham; The Reigate Centre, Sheffield Children's Hospital; Radcliffe Hospital, Oxford; Guys Hospital, London and the Royal Infirmary, Newcastle.
Who is suitable?
This treatment will not be suitable for everyone who has cerebral palsy or a neurological condition. For example, it does not help people with low muscle tone (often described as floppy muscles), chorea (uncontrollable, small jerky movements of toes and fingers), or athetosis (involuntary movements of face, arms and trunk). It is recommended for severe generalised spasticity.
There is a clear screening process that is applied to each individual child or adult. The final stage, before the pump is inserted, is to give potential patients a test dose of Baclofen direct into the spine via a lumbar puncture. This lasts four hours and is to ensure that this method of delivering the drug is suitable.
Children as young as five years have received ITB, but it does depend on the size of the cavity in the abdomen in which the pump sits.
Is this treatment safe?
The role of the Medicines Control Agency (a part of the Department of Health) is to grant licences to drugs that are safe and effective. They also have a remit to continue to monitor the use of licensed drugs.
The most common side-effects of the Baclofen when delivered by pump include loose muscles, drowsiness, nausea, headache and dizziness. However, these are usually temporary and manageable by adjusting the dose.
The pump itself needs to be refilled typically every two months and this is accomplished by inserting a needle through the skin into the pump. Some clinicians will use a local anaesthetic if necessary for this. The pump will need to be replaced after five or six years.
Other potential side effects are Baclofen withdrawal and Baclofen overdose. Early signs of Baclofen withdrawal include an increase in spasticity beginning in lower limbs, itching skin, seizures, and increased temperature. In some cases there can be serious psychiatric symptoms such as hallucinations, paranoia, psychosis and confusion.
Early signs of Baclofen overdose include excessive weakness of the lower limbs, excessive sleepiness, nausea and vomiting and dizziness.
Some potential risks include those associated with the pump. For example, the tube may move, kink or break or part of the pump may fail to work.
It is important that this treatment is accompanied by therapy. This can involve intensive physio and occupational therapy in the first few weeks after the operation. Therapy may continue for several months.
What research has been done on ITB?
There have been trials of ITB in the USA, undertaken by Professor A Leland Albright of the Department of Paediatric Neurosurgery, Children's Hospital, Pittsburgh. The latest is to be published in an academic journal, but Professor Albright has told Scope that in the trial two-thirds of the 23 people with cerebral palsy who have been treated with this therapy have shown a decline in their spasticity. The patients ranged in age from eight years old to their mid-thirties. There is also a series of articles in the USA journal Exceptional Parent, which began in November 1996, giving some individual case studies.
Evidence from the UK and other countries would seem to suggest that some children with cerebral palsy when given ITB enjoy an improved quality of life.
Funding
Funding for ITB by Health Authorities is inconsistent. Your doctor or consultant should be able to advise you further.
Further information
The following website is for people treated with or interested in ITB. Log onto www.baclofen.info
As with any therapy or treatment, Scope would advise people with cerebral palsy, their carers or parents to consult their GP, consultant or health professional before starting or paying for any treatment. Due to the individual nature of cerebral palsy, some children will benefit from specific treatments and therapies, others will not. Assessment of your child's individual needs is very important.
This document is for information purposes only.
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