1. Will ITB cure my spasticity?
No. Intrathecal baclofen manages the severe spasticity only but cannot remove or cure the cause or underlying condition. |
2. How will I know that I will benefit?
The test-dose procedure where a single or a series of injections are given directly into the intrathecal space will provide the medical team with a very strong indication of whether the child will benefit before the pump is implanted. Once the results of the test-dose are observed, the medical team will fully discuss what benefits ITB will be expected to achieve and what symptoms will not be affected. The clinical benefits of ITB are often maximised further by combining it with other therapies such as botulinum toxin and especially physiotherapy. It is often found that ITB Therapy allows for more concentrated physiotherapy or different programmes to be initiated because of the relaxation of the tight muscles. |
3. Why will ITB Therapy work when oral baclofen does not?
Baclofen needs to reach the GABA receptors found mainly on the back of the spinal cord to exert its anti-spasticity effect. Taking baclofen orally in tablet form means that the drug needs to enter the bloodstream via the stomach and circulate until it crosses through the covering membrane (blood-brain barrier) that surrounds the CSF surrounding the spinal cord. Because of the chemical nature and structure of the baclofen molecule, crossing the blood-brain barrier is not easy. It requires the child to take large oral doses to achieve a small clinical effect. These large doses often lead to unpleasant side-effects.
Intrathecal baclofen is a liquid formulation of the oral drug enabling it to be delivered via a catheter directly into the intrathecal space where the receptors are, so bypassing the blood-brain barrier. Only very small doses are needed to give a strong positive clinical effect on the spasticity. |
4. Will ITB Therapy improve comfort and physical ability?
Intrathecal baclofen therapy cannot produce any abilities that the child does not have already. However, relieving severe spasticity together with physiotherapy can often enable children to realise their full potential. |
5. Will other medications need to be stopped?
The medical team will fully discuss what other medications can or cannot be taken in conjunction with ITB and how to take them appropriately. Medications must not be stopped without first seeking medical advice. |
6. Will there be any problems if the patient becomes pregnant?
The surgical procedure and pump implant can be planned if there is a potential that pregnancy may be considered in the future. This must be fully discussed with the medical team well in advance of a pump implant. The position of the pump and the coiling of the catheter as it is tunneled beneath the skin can allow for an increase in body size without interruption of the infusion of the baclofen. It is important to note that the clinical experience of ITB during pregnancy is limited but is reported in the clinical literature. It is also known that oral baclofen can be found in breast milk but data are not known concerning ITB Therapy. |
7. Will the pump be noticeable?
The dimensions of the pump are 87.5mm in diameter and either a thickness of 19.5 or 26mm. Dependent on the implant technique of the surgeon, the choice of reservoir size of the
SynchroMed II pump and the size of the patient, the pump may or may not be noticeable as a small bulge of the skin in the lower abdomen. The pump is usually implanted below the “belt-line”, which combined with loose clothing; is unlikely that anyone other than the patient will be aware of the implant. |
8. What is the pump made of?
The pump is made of titanium - an extremely inert metal deliberately chosen to minimise the potential of an allergic reaction. In addition, the catheter is made of silicone, again to reduce the risk of an allergic reaction. Because the pump is metal, it will however activate airport and shop security systems depending on the sensitivity at which they are set. The child/carer should always carry their ID card, if they have been given one, to explain that they have been implanted with an active medical device. It is strongly recommended that the patient proceeds through the centre of any security gate or archway if it cannot be avoided. If possible ask for a security clearance using a “wand” scanner. |
9. Can the patient have a scan once implanted?
A patient with an implanted SynchroMed II pump can safely have an X-ray. Although made of titanium an implanted patient can also have a CT or MRI scan.
During a MRI scan, the scanner's magnetic field will temporarily stop the pump's motor from turning and so stopping the delivery of baclofen. Once the MRI scan has finished, the pump will spontaneously restart continuing the programmed delivery of ITB. It is usual for the SynchroMed II pump to be interrogated using the physician programmer pre and post the scan to ensure continuation of the prescribed ITB Therapy. The scanner department can request guidelines from Medtronic prior to scanning an implanted patient. |
10. What happens if the pump runs out of baclofen?
It is unlikely that a pump's reservoir will completely empty if the child's carer strictly adheres to the appointment schedule provided by the medical team.
The physician programmer used during the pump refill will inform the medical team of the date when the pump will eventually run out of drug. The next pump refill is usually scheduled two weeks prior to this date. In addition to this, a “low reservoir” alarm can be programmed to initiate a soft alarm to sound when the reservoir has only 2 millilitres of baclofen remaining. This alarm if it should sound can only be deactivated by the physician programmer. If the alarm is heard then the medical team should be immediately contacted to schedule a hospital outpatient visit.
In the unlikely event that the pump reservoir should empty before it is refilled then the patient's spasticity will return very quickly and can be very unpleasant and uncomfortable. In addition, other side-effects of baclofen withdrawal will become apparent. |
11. How will you know when the pump needs to be replaced?
The battery contained within the pump will last approximately 7 years. During routine visits to the medical team they will be able to monitor the battery life of the pump using the physician programmer. They will be able to actively schedule a pump replacement before the existing battery expires to ensure continuity of therapy. The SynchroMed II pump also has a feature which estimates the battery life and when it is expected to expire. |
12. What are the side-effects of baclofen withdrawal or overdose?
It is important that as many friends, family and carers know and are able to recognise the early signs of either baclofen withdrawal or overdose so that the child can receive appropriate intervention from a medical team if necessary.
Early signs of baclofen withdrawal include, but are not exclusive to, the following:
• Increase in spasticity of the muscles beginning in the lower limbs first
• Pruritis (itching skin)
• Seizures
• Hallucinations
• Hyperthermia (increased temperature)
Treatment of baclofen withdrawal is usually an immediate administration of oral baclofen.
Early signs of baclofen overdose include, but are not exclusive to, the following:
• Excessive weakness of muscles beginning in the lower limbs first
• Sedation and excessive sleepiness
• Nausea and vomiting
• Dizziness
Severe overdose can cause severe flaccidity of the muscles and coma requiring intensive care and assisted ventilation until the excessive dose of baclofen is metabolised (broken down) by the body. Baclofen even in an overdose situation is non-toxic to neural tissue.
The child or immediate carer should always carry an ID card, if supplied by the medical team, to be able to assist other healthcare professionals if required. It is also useful that relevant school staff become fully conversant with ITB Therapy, its clinical benefits and signs of any alterations in the clinical effectiveness. |
13. What are the risks associated with intrathecal drug delivery?
Complications involving the pump are rare and have only been seen in a small number of patients. However, since the therapy involves a surgical procedure, complications such as infections are possible, which, if severe may necessitate pump and catheter removal. In this circumstance, antibiotics are given until such time that the medical team are confident that the infection has been treated and a replacement pump system will be re-implanted.
The catheter, being a thin flexible tube couldbecome blocked, twisted, punctured or dislodged from the intrathecal space resulting in disruption to the therapy experienced as a loss or reduction of clinical effect. In these instances it may be necessary to surgically replace the catheter. |
14. How can my child receive ITB Therapy?
To be considered for ITB Therapy it is essential that the child is assessed by a multidisciplinary team experienced in the management of spasticity. This assessment begins with a referral by the child's immediate caring physician to a nominated physician in this specialist team. This physician, usually a paediatric neurologist, will carefully assess the suitability of the child excluding any contraindications and ensure that other therapies have either been exhausted or excluded. |
15. Is this therapy funded by the NHS?
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 often takes many 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. |
16. How long is the wait between test-dose and the implant?
After a successful test-dose the waiting time before the implant is dependent on a number of variables that include the funding agreement process, operating theatre capacity, available bed space and NHS waiting list directives. Once approved for ITB Therapy, the maximum time that the child will wait for the implant will be dependent on the maximum waiting list time that the hospital complies with. In certain NHS Trusts this may be a maximum of a 6 months' wait. |
17. Will the SynchroMed pump be affected by anything?
The SynchroMed II pump is designed to allow the safe use of most common household appliances without worry for the implanted patient. These include microwave ovens, televisions, radios, mobile phones, remote controls and video games etc. However, like the MRI procedure, strong magnets can temporarily interrupt the baclofen delivery so strong magnetic fields should be avoided. In addition, the pump is unaffected by hot baths, showers or saunas except in very special circumstances combining a very high body temperature caused by illness, very high external temperatures and prolonged exposure to those temperatures.
The SynchroMed II pump has a monitoring circuit that constantly checks its actual delivery against the programmed parameters. Any discrepancy that the pump detects causes it to stop and triggers a “pump memory error” alarm heard as a soft double-beep. You should contact the medical team if you hear this alarm or any other alarms for immediate advice. |
18. Will flying affect the SynchroMed pump?
Flying will not generally affect the operation of the pump or the delivery of the ITB. It is always advisable to informthe medical team prior to any long flights or flights in any non-pressurised aircraft for any recommendations. If travelling on holiday please ensure that the pump contains enough medication for the holiday duration. |
19. Living with a SynchroMed II pump: What am I able to do?
The implantation of an intrathecal SynchroMed II baclofen pump allows the patient to perhaps enjoy a more fulfilled life as a direct result of the better management of the severe spasticity that may have been restricting the child's quality of life and functional ability.
Improved spasticity control can allow the medical team to implement additional or enhanced clinical treatments to maximise and improve functional abilities of the child.
Children implanted with a SynchroMed II pump are able to participate and enjoy activities similar to other children. Caution should be observed with any activity that involves the risk of a direct blow to the site of the implanted pump or activities that involve rapid and repeated twisting/rotation of the child's torso. |
