INTRATHECAL BACLOFEN THERAPY

General information
More than 80% children with Cerebral Palsy have spasticity. Spasticity interferes with care and ability to function. In, many cases, spasticity is adequately managed with oral medication and rehabilitative interventions. But some patients do not respond oral medications, or experience intolerable side effects at effective doses. In those cases Intrathecal baclofen is the one of the best options.

ITB therapy is different from oral medications because it delivers a form of the drug Baclofen directly to the fluid around the spinal cord. Baclofen is similar to GABA and works in the spinal cord, promoting muscle relaxation. Because the medication is delivered directly to the site of action without circulating throughout the body, it relieves spasticity with very tiny amounts of medication. This delivery system minimizes side effects. Delivery makes the difference in ITB therapy, which has been shown to be highly effective in people with severe spasticity, including those who have not had good results with oral medications. 

ITB therapy is Lioresal� Intrathecal (Baclofen injection), administered by the Infusion system. It provides an effective, non - destructive, reversible, alternative for pediatric and adult patients with uncontrolled spasticity due to multiple sclerosis, spinal cord injury, cerebral palsy, brain injury or stroke.

Benefits of ITB therapy
In addition to a reduction in spasticity and spasms, patients may experience substantial secondary benefits as a result of the decreased spasticity. 

Potential Risks of ITB Therapy (Drug, Pump, and Surgery)
ITB Therapy involves the surgical placement of a pump and catheter. As with any surgical procedure, there is the potential for infection. 

Patients may experience symptoms caused by too much drug. Watch for any unusual reactions and alert the patient's physician immediately if any of the following are observed:

• Drowsiness
• Increased weakness
• Dizziness
• Seizures
• Headache
• Nausea / vomiting

Selection of Right Candidates for ITB Therapy
The following patient selection guidelines are recommendations for possible ITB Therapy candidates with severe spinal and cerebral origin spasticity-
Patients at least 4 years old with sufficient body size tom support the pump.
Patients whose spasticity and / or spasms interfere with function or daily activities
Patients whose spasticity and / or spasms interfere with care or positioning
Spinal origin patients whose oral medications are ineffective or cause intolerable side effects
Patients with pain due to spasticity
Patients who need varying degrees of tone throughout the day for function or activities of daily living

Patients who are hypersensitive to oral Baclofen are not candidates for ITB Therapy.

Patients with spasticity due to traumatic brain should wait at least one year after the injury before consideration of long - term intrathecal Baclofen therapy. 

Goal Setting
Realistic goal setting is a key to satisfaction with ITB Therapy. Depending on the level of ability, a patient may be able to accomplish certain goals with the help of ITB Therapy. Treatment goals vary considerably. The rehabilitation team assesses the patient to determine whether function or ease of care would improve with reduced spasticity.

Goals for other patients may include: improved ease of care, comfort positioning, and prevention of further contractures. For patients dependent on other for their care, ITB Therapy can make a significant difference in quality of life, for both patient and the caregiver. 

The Screening Test
Individuals who have been identified as candidates for ITB Therapy should first be given a screening test before proceeding to pump implant. The screening test verifies that the patient's body will respond to ITB Therapy. The examiner should assess the patient immediately before the screening test begins, using �Modified Ashworth Scale. Muscles with the greatest amount of spasticity should be tested. �An average score for the lower extremities should be calculated. The upper extremities may also be assessed but not included in the average score. There is not always a reduction in upper extremity spasticity during the test, but there may be an effect once the patient receives ITB Therapy with an implanted pump. 

To perform the screening test, a bolus dose of 50 mcg of Baclofen injection is administered by lumbar puncture or an external intrathecal catheter. 

After the drug bolus is administered, the examiner should assess spasticity on a regular, scheduled basis over an 8-hour period. The goal of the assessment is to quantify change in spasticity over time. 

Positive response:
Patients who respond better to the bolus are candidates for ITB Therapy. At most centers, a positive response is a least at 1 point reduction in the average Ashworth score for the lower extremities, for one or two observations during the screening test. 

Patients who do not respond to the first bolus dose can be re- tested over the next 2 days with bolus doses of 75 mcg and 100 mcg, if needed, administered 24 hours apart. Those who respond may then be scheduled for the therapy. 
For patients with goals of improved function, therapy is an important adjunct to ITB therapy. Intensive physical therapy (3-5 times per week) usually begins about a months after implant. The waiting period before intensive therapy allows incisions to heal as well as time for the therapy dose to be titrated to a level that significantly reduces spasticity. 

During this intensive period, therapeutic exercise to strengthen weakened muscle groups and to stretch shortened muscles is important. Motor learning is important in making functional gains. New patterns of movement need to replace patterns of inefficient movement. 

In the first few months after implant, the patient's dose will most likely require several adjustments. The rehabilitation team can provide valuable information to the physician regarding the dose adjustments that might benefit the patient. If spasticity is interfering with function, the dose may need to be increased. Each time, the dose is adjusted, the patient needs to accommodate to the change. Rehabilitation is an ongoing process, and some patients do not make functional gain until several months after implant. Reassure patients that strengthening and motor learning takes time. 

Recognize the symptoms of Baclofen overdose:
Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures muscle weakness typically progressing upward from the lower extremities, and loss of consciousness progressing to coma. Contact the patient's doctor immediately. Dose adjustment is an ongoing process, with more frequent adjustments required in the first few months after implant to reduce spasticity and spasms without adverse side effects.

Conclusion-Our Experience
Due to our association with Medtronics, we have vast experience with this procedure. In fact, ICD was one of the first organizations which did the first study of Usage of Baclofen Pump Therapy with children with cerebral palsy in India. Our experience with Intrathecal baclofen therapy is mixed. A few cases have shown remarkable results after the procedure. At the same time, unfortunately, few examples are there with failures also.

Children with global / generalized spasticity and good cognition are always suitable candidates for ITBP therapy. ������

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