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, some patients do not respond well to oral medication or develop unacceptable side-effects.

It is often preferable to implant a system that can accurately and safely deliver drugs directly into the nervous system. By delivering the medication directly into the spinal cord where it is needed, improved effects can be achieved on smaller doses than with oral medications and some of the potential side effects minimised.

How does ITB work?

Baclofen is delivered directly into the spinal fluid by a pump that is implanted under the skin of the abdomen and connected to a thin flexible catheter. The catheter is tunnelled beneath the skin into the intrathecal space in the spinal cord where it delivers a precisely controlled dose of the medication. The function of the pump can be altered to suit the individual so if you or your child needs a higher dose of medication at different times of the day, the pump will be programmed to this effect. The pump is about the the size of an ice hockey puck, but can be easily housed in the abdominal cavity. 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.

What are the benefits of ITB?

ITB can improve activities of daily living function and ease of care for example allowing more independence in feeding and dressing, or sitting and transferring more comfortably. It also helps carers in their role with approximately 94% (1) of caregivers being satisified with ITB.

With cerebral palsy some of the specific benefits are as follows:

• Facilitating improvements in self care and social function (2)
• Improved motor control and function (3)
• If offered at appropriate time, ITB may reduce need or extent or orthopaedic and surgical intervention (4)
• Reduction in muscle tone with ITB may slow or prevent hip problems or dislocation (5)
• Long term control of spasticity (6)

Side effects and risks

Side effects of baclofen can include hypotonia (loose muscle tone), sleepiness, upset stomach, vomiting, headaches and dizziness.

ITB is a surgical procedure and like all surgery will carry risks in itself. Infection, bruising, bleeding, spinal fluid leakage, headache and discomfort may be experienced but the medical team will discuss all these with you beforehand.

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.

However, ITB is becoming more available and your child will be under the care of an experienced team so side effects and risks are minimised.

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. This test dose procedure will provide the medical team with a very strong indication of whether you or your child will benefit

The key to the success of ITB is active involvement and co-operation with the medical team. It is extremely important that all outpatient visits are attended for refills and follow up assessment. Follow-up visits vary from weeks to months depending upon the dose of medication.

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 is the pump made of and how will I know when it needs to be replaced?

The pump is made from titanium and the catheter from silicone. Both these materials are unlikely to cause an adverse or allergic reaction.

The battery within the pump can last several years. During visits to your medical team, they will monitor the battery life and can schedule a pump replacement before the existing battery expires. The pump also has an alarm which will prompt you to see the medical team before the battery runs out.

What research has been done on ITB?

There have been several research papers published around ITB and the administration of Baclofen. For further information see the booklet “ITB Therapy” published by Medtronic.

Where can I get ITB and will I have to pay?

Funding for ITB can be inconsistent. Almost all medical and surgical treatments are funded by the patient's Primary Care Trust (PCT). The funding decision is based upon a number of factors that include the clinical need, the published evidence of the therapy, PCT priorities and the availability of appropriate funds. Once the child has been assessed as suitable for ITB Therapy, the medical team contacts the relevant PCT for an agreement to fund. This process may take months with the child placed on a waiting list until agreement is made. Occasionally funding is refused. If so, there is the right to appeal.

A list of hospitals and centres offering ITB can be found on www.baclofen.info

Further information

Medtronic UK Ltd
Tel: 01923 212213
Web: www.medtronic.co.uk

Baclofen.info
Web: www.baclofen.info

References

(1) Campbell SK, Almeida GL, Penn RD, Corcos DM. The effects of intrathecally administered baclofen on function in patients with spasticity. Physical Therapy 1995; 75: 352-62

(2) Awaad Y, et al. Functional assessment following intrathecal baclofen therapy in children with spastic cerebral palsy. Journal of Child Neurology 2003; 18: 26-34

(3) Krach LE, et al. GMFM 1 year after continuous intrathecal baclofen infusion. Pediatric Rehab 2005; 8 (3): 207-213

(4) Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent orthopaedic surgery in patients with spastic cerebral palsy. Journal of Neurosurgery 1998; 88 1009-1013

(5) Krach LE, Kriel RS, Gilmartin RC et al. Hip status in CP after one year of continuous intrathecal baclofen infusion. Pediatric Neurology 2004;30: 163-168

(6) Gilmartin R, Bruce D, et al. Intrathecal baclofen for management of spastic cerebral palsy; multicenter trial. Journal of Child Neurology 2000; 71-77

Contact Scope Response for information, advice and support on cerebral palsy and disability issues.

This information was last reviewed May 2010.