Cerebral Palsy Treatments:
Intrathecal baclofen therapy - (ITB) for
spasticity
Content Provided by Scope
What is ITB?
Baclofen is a drug produced as a muscle
relaxant. It has been used to relieve the stiffness caused by spasticity.
However, when it was taken orally it was found
to have many side-effects, including lethargy and loss of balance. In June 1996,
the US Food and Drug Administration approved a new system of delivering the drug
to people with spastic cerebral palsy, called Intrathecal Baclofen Therapy (ITB).
The system is 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 into the
spinal fluid via a small tube. 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
spinal fluid, the drug can act as a muscle relaxant and reduce spasticity in the
lower limbs without the side-effects associated with the oral administration of
the drug.
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).
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 an appropriate dose of Baclofen direct
into the spine via a lumbar puncture. This 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. The pump will take about 50 minutes for an experienced surgeon to
insert.
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.
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. In the USA 5% of the treatments carried out have resulted in
infections that have required the temporary removal of the pump.
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.
Further information
The following website is for people treated
with or interested in ITB. Log onto
www.baclofen.net
As with any therapy or treatment, we 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 factsheet is for information purposes
only and is not intended to be a recommendation.
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