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Treatment of cerebral origin spasticity with continuous intrathecal baclofen delivered via an implantable pump: long-term follow-up review of 18 patients.

OBJECT: The goal of this study was to assess the long-term benefits of managing severe spasticity by using continuous infusion of intrathecal baclofen delivered via an implantable pump. METHODS: Eighteen patients with severe spasticity of cerebral origin, who failed to respond adequately to more conservative treatments, have-been treated with continuous infusion of intrathecal baclofen delivered via an implanted pump. Follow-up review of these patients has lasted between 12 months and 9 years. The patients have been assessed using a variety of tools. Seventeen have had a significant reduction in tone and all have benefited by a reduced need for nursing care or increased function or both. CONCLUSION: Long-term continuous infusion of intrathecal baclofen delivered via an implantable pump offers an effective method for dealing with otherwise intractable spasticity.

Adolescent↗

Continuous intrathecal pump infusion of baclofen with antibiotic drugs for treatment of pump-associated meningitis. Case report.

Intrathecal baclofen administered by means of an implantable pump is being increasingly used for successful treatment of spasticity. Meningitis following intrathecally administered baclofen is a rare but serious complication that is difficult to treat without removal of the pump. Because success rates with intravenously administered antibiotic drugs for the treatment of meningitis have been low, intrathecal administration of antibiotic agents is often required to eradicate the pathogen. The authors report the case of a patient in whom Staphylococcus epidermidis meningitis developed after insertion of an intrathecal baclofen pump. The patient was successfully treated by intrathecal coadministration of vancomycin and baclofen.

Adult↗

Attenuation of cerebellar tremor with implantation of an intrathecal baclofen pump: the role of gamma-aminobutyric acidergic pathways. Case report.

The authors present the case of a 49-year-old woman with disabling bilateral upper-extremity cerebellar tremor that resolved unexpectedly after placement of an intrathecal baclofen pump for lower-extremity spasticity. The tremor amplitude decreased nearly linearly with increasing intrathecal baclofen dosage, and disappeared completely at a dose of 250 microg/day. In this report the authors demonstrate the role of the gamma-aminobutyric acidergic system in the pathogenesis of cerebellar tremor, and these findings may lead to a new treatment modality for patients disabled by this manifestation of their disease.

Baclofen↗

Performance and complications associated with the synchromed 10-ml infusion pump for intrathecal baclofen administration in children.

OBJECT: The objectives of this multicenter study were to monitor the performance of a 10-ml pump infusing intrathecal baclofen to treat 100 children with cerebral spasticity, to monitor complications associated with the pump, and to correlate pump-related complications with body habitus. METHODS: Age at implantation of the pump ranged from 1.4 to 16.8 years (mean 8.1 years). The effects of ITB on spasticity in the upper and lower extremities were evaluated using the Ashworth Scale. Data were collected regarding implant site, infection, complication, and body mass index (BMI). Ashworth Scale scores decreased significantly in the upper and lower extremities at 6 and 12 months after pump implantation (p < 0.001). There were four serious system-related complications, all specific to catheters. There were 32 serious procedure-related complications in 21 patients: 11 complications were infections that occurred in nine patients. Four of nine pump-induced infections were treated with pump removal and antibiotic therapy; five infections were treated successfully with antibiotic therapy alone, without pump removal. In children younger than 8 years of age there was a significantly higher incidence of serious procedure-related adverse events than in older children. There was no significant correlation between BMI and the incidence of pump pocket-related complications or infections. CONCLUSIONS: The 10-ml pump can be used therapeutically in small children, particularly those weighing less than 40 lbs, with greater ease and less wound tension, than the conventional 18-ml pump. The incidence of complications associated with the 10-ml pump in younger children appears to be similar to that previously reported with the 18-ml pump in larger-sized children.

Adolescent↗

CNS innervation of the urinary bladder demonstrated by immunohistochemical study for c-fos and pseudorabies virus.

The aim of the present study is to verify the functional and anatomical neural pathways which innervate the urinary bladder in the central nervous system of the rat. To identify the functional neural pathway, the urinary bladder was stimulated by infusing formalin for 2 h. Then, brain and spinal cord were dissected out and immunohistochemistry was done by using anti-c-fos antibody. Many c-fos immunoreactive (IR) neurons were identified in the telencephalic cortical areas and in several brainstem nuclei, which are known mostly to be related with urinary bladder. In the spinal cord, a number of c-fos IR neurons were found in the lamina I, IIo, dorsal gray commissure, sacral parasympathetic nucleus. To identify the anatomical neural pathway of the urinary bladder, Pseudorabies virus (PRV) was injected into the wall of urinary bladder and was identified with anti-PRV by using immunohistochemistry. Most PRV labeled neurons were found where c-fos IR neurons were identified and few of them were also in the areas where c-fos IR neurons were not found, e.g., prefrontal cortex, agranular insular cortex, and subfornical organ. In the spinal cord, PRV labeled cells were found all over the gray matter. The present study presents morphological evidence demonstrating the supraspinal areas are related with the neural control of the urinary bladder and most functional neural pathway of the urinary bladder is well consistent with the anatomical neural pathway except in some telencephalic cortical areas.

Animals↗

[Continuous intrathecal administration of nicardipine using a portable infusion pump system for management of vasospasm after subarachnoid hemorrhage].

We studied the feasibility of intrathecal nicardipine administration using a portable infusion pump system in five cases (two males and three females) of subarachnoid hemorrhage (SAH). All of the five cases manifested severe SAH of Hunt & Kosnic grade 3 or 4, and Fisher CT group 3. Aneurysmal sites of five cases were as follows: three internal carotid-posterior communicating artery (IC-PC) aneurysms and two anterior communicating artery (Acom) aneurysms. The container of the infusion pump system was filled with 105 ml of nicardipine-saline solution (2:1), and this system was connected to the cisternal tube. The solution was continuously injected at a daily dose of 12 ml (8 mg of nicardipine). This therapy was continued for 14 days, and new nicardipine solution was supplied only once at 8 days after the operation during this therapy. No postural restraint of patients was necessary, even during physical movement for rehabilitation. Postoperative angiography was performed in three of five cases at one week after the operation. No angiographic vasospasm was observed in any of the three cases. Symptomatic vasospasm was observed in one case of right IC-PC aneurysm as a transient total aphasia and right hemiplegia, which recovered within several hours due to induced hypervolemia and hypertension therapy. Mild meningitis at 14 days after the operation complicated this treatment in one case, but it improved in a few days after the cisternal tube was removed. It was speculated that meningitis was caused by cerebrospinal fluid leakage from the scalp exit site of the cisternal tube. All of the five cases had obtained good recovery at three months after the operation. These results show that, although this method involves a risk of infection, it has the advantage of easiness and convenience over conventional methods. Though further improvement of this method is required, this preliminary stage is potentially useful for delivering not only nicardipine, but also for other drugs which may be used in intrathecal administration therapy.

Aged↗

Monitoring of creatinine kinase during weaning of intrathecal baclofen and with symptoms of early withdrawal.

Abrupt withdrawal from intrathecal baclofen (ITB) can result in severe rebound spasticity, confusion, and seizures. It has been recently recognized that abrupt withdrawal from ITB may, in rare cases, result in life-threatening rhabdomyolysis, hyperthermia, autonomic disturbances, and sepsis-like presentations. Early recognition of the most severe forms of the withdrawal syndrome is essential for effective intervention. The common and unique features in such individuals seem to be severe increased spasticity and marked elevation in creatinine kinase levels. This case of an individual with T4 paraplegia with recurrent episodes of ITB withdrawal associated with severe spasticity and elevated creatinine kinase levels who required rapid weaning of high-dose ITB to allow removal of an infected pump and catheter illustrates the value of monitoring creatinine kinase levels in evaluation of suspected ITB withdrawal and during rapid weaning of ITB when necessary.

Adult↗

[Intrathecal baclofen for treatment of spasticity in patient with cerebral palsy--a preliminary report].

Spasticity is a common symptom of upper neuron damage which requires continuous research for new treatment strategies. The aim of this paper is to present the result of intrathecal baclofen infusion in treatment of spasticity in patients with cerebral palsy. Three patients (aged 16 to 21 years) in whom baclofen pumps were implanted underwent clinical and neurophysiological assessment both before and after pump implantation. Early results of spasticity treatment in cerebral palsy with intrathecal baclofen infusions are very promising.

Adolescent↗

[Intrathecal baclofen in severe spasticity due to multiple sclerosis].

Intrathecal administration of baclofen via programmable pump is a highly effective treatment method in severe spasticity resistant to oral medications. The authors describe a case of severe spasticity with tetraplegia and painful (> 10 a day) muscle spasms in the upper and lower limbs and paraspinal muscles, in a patient with clinically definite diagnosis of multiple sclerosis (MS). The 34-year-old female patient with a 15-year history of MS, suffering from lower limb spasticity with pes equinovarus since 1995, was treated with very good results with botulinum toxin injections of calf muscles (14 sessions of Dysport 1500iu till 2002). In the early 2002 she developed tetraplegia with severe, generalized and intractable spasticity. After 4 months of ineffective polytherapy (with high doses of oral baclofen, tizanidine, gabapentine, clonidine, diazepam) and the patient's enormous sufferings (she could neither sit up nor voluntarily change her position in bed), a programmable baclofen pump (Medtronic) was implanted. As soon as a few days after the surgery she could stand, sit and move voluntarily, her painful spasms disappeared, and her bladder catheter was removed. At a 6-month follow-up the effect was stable--she was able to walk a long distance outdoors with the aid of a crutch. The daily dose of the drug is 500 micrograms. No side effects of complications were noted.

Adult↗

Quality of life of patients with telemetric pumps for intrathecal baclofen infusion: data and limitations of assessment scales.

Over the past three decades, telemetric pumps have been used for the infusion of intrathecal baclofen in patients with severe spasticity, but the correlation between pump implantation and quality of life (QoL) has rarely been studied. The aim of this study was therefore to quantify QoL in these patients. We assessed 15 candidates for intrathecal baclofen infusion pump implantation using three scales: Self-Evaluation of Life Function, Quality of Life Index, and Quality of Well-Being Scale. These scales were administered a week before pump implantation and 12 months after reaching the optimal dosage. The first scale revealed a significant increase in QoL, whereas on the other two the increase was not significant. These results encourage us to continue this study in a larger patient sample, considering different types of pathology and presence/absence of caregivers.

Adult↗

Dosage of intrathecal baclofen maintenance therapy in the spastic syndromes.

Twenty-three patients affected with severe spasticity as a result of several clinical pathologies were treated with intrathecal Baclofen and administered at a lumbar level by means of an implantable infusion system. The system allows programming of any drug dosage in a continuous infusion fashion in the subarachnoid space. The appropriate patients were selected using specific criteria and the patients were regularly reviewed regarding the level of the spasticity and functional capacity. The required daily doses were determined using a specific detailed system. The doses needed varied according to the pathologic or clinical diagnosis. The doses administered by the global method at the beginning of the treatment were 91.96 microg/day and 137.81 microg/day in the final phase. These doses were higher in patients with medullary traumatic lesion, diffuse cerebral lesion and spastic idiopathic paraparesis. Relatively mild side effects were produced by the therapeutic doses used.

Adult↗

[Treatment of amyotrophic lateral sclerosis with daily intrathecal TRH. A year's experience. Pilot study II].

This study presents the experience of one year of treatment in patients with amyotrophic lateral sclerosis, with intrathecal TRH administered daily by a subcutaneous reservoir connected to the intrathecal lumbar space by a double catheter system as to provide continuous circulation of CSF and to avoid sac formation since this would be a source of infection. Clinical evaluation was carried out with a scale developed by the authors with the main aim of evaluating the loss of vital motor abilities and not as a localized evaluation. Secondary effects due to the implantation of the reservoir in addition to its use are presented although data were not important. Intrathecal administration of TRH was carried out similarly (600 micrograms/day) with secondary effects being the same as those by other routes of administration although of a lesser intensity. The results of the clinical evaluation at the beginning and end of the treatment as well as after patient follow up demonstrated that beneficial effects do not occur equally in all patients but rather are transitory and do not improve the natural evolution of the disease. The authors conclude that, methodologically, this series study does not enter within the frame of an advisable statistical study since the aim is to provide data for a future controlled study.

Adult↗

Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices.

A substantial number of patients with cancer suffer considerable pain at some point during their disease, and approximately 25% of cancer patients die in pain. Providing effective pain management for patients with severe pain that impacts quality of life can present the oncologist or palliative care specialist with complex clinical challenges that often require multifaceted therapeutic measures. This paper presents multidisciplinary consensus-based recommendations for the treatment of intractable cancer pain using intrathecal drug delivery systems, which offer rapid and effective pain relief with less toxicity relative to oral or parenteral administration. Intrathecal drug delivery systems can be highly effective in a variety of patient settings, including cases of refractory pain, diminished performance status, poor tolerability of oral medications, polyanalgesia for complex pain, and inadequate dosing due to addiction concerns. The use of implantable or external systems is discussed, as well as implantation procedures, drug titration recommendations, and management of potential side effects. The authors offer a newly developed algorithm for delivering intraspinal analgesia in patients with cancer. The intent is that increased understanding of available options for truly effective pain management in the oncology and palliative care arena and the benefits of multidisciplinary cooperation will translate into genuine improvements in patient quality of life and a measurable decrease in the number of patients who suffer needlessly in their final days.

Analgesia↗