Chronic intrathecal delivery of baclofen by a programmable pump for the treatment of severe spasticity

1996 ◽  
Vol 85 (3) ◽  
pp. 452-457 ◽  
Author(s):  
Joe I. Ordia ◽  
Edward Fischer ◽  
Ellen Adamski ◽  
Edward L. Spatz
Keyword(s):  
Average Length ◽  
Controlled Trial ◽  
Treatment Protocol ◽  
Intrathecal Baclofen ◽  
Open Label ◽  
Content Type ◽  
Severe Spasticity ◽  
Before And After ◽  
Double Blinded ◽  
Fine Print

✓ The aim of this study was to determine the efficacy, safety, and cost-effectiveness of intrathecal baclofen delivered by a programmable pump for the chronic treatment of severe spasticity. Sixty-six patients with severe spasticity of spinal cord origin that was refractory to oral baclofen or who experienced intolerable side effects with this form of the drug were screened. The first nine participated in a double-blinded, randomized, placebo (normal saline)-controlled trial to determine response to a bolus dose of intrathecal baclofen. Subsequent patients were enrolled in an open-label treatment protocol without a placebo trial. All passed the screening, and the pump was implanted in 59 patients. Spasticity scores and medical costs before and after surgery were analyzed. In all patients, the mean Ashworth score for rigidity decreased from 4.3 preoperatively to 1.4 (p < 0.0005) with use of intrathecal baclofen. The spasm frequency score decreased from a mean of 3.6 to 0.5 (p < 0.0005). Activities of daily living, sleep, and skin integrity improved, and pain was eradicated in some. Constipation occurred in six patients. A reduction in dosage was necessitated by muscular hypotonia in three ambulatory patients, areflexic bladder and urinary retention in three others, and nausea, dizziness, and drowsiness in one. Catheter-related problems occurred 19 times in 15 patients. One pump was explanted because of infection in the pump pocket, and one was removed after it eroded through the skin. There were no pump failures. The use of intrathecal baclofen resulted in a decrease in the average length of subsequent hospitalizations. It is concluded that intrathecal baclofen delivered by an implanted programmable pump is a safe, effective, and cost-efficient method for treatment of severe intractable spinal spasticity.

Infusion of intrathecal baclofen for generalized dystonia in cerebral palsy

1998 ◽  
Vol 88 (1) ◽  
pp. 73-76 ◽  
Author(s):  
A. Leland Albright ◽  
Margaret J. Barry ◽  
Michael J. Painter ◽  
Barbara Shultz
Keyword(s):  
Cerebral Palsy ◽  
Intrathecal Baclofen ◽  
Term Therapy ◽  
Short Term ◽  
Intrathecal Catheter ◽  
Content Type ◽  
Body Regions ◽  
Before And After ◽  
Generalized Dystonia ◽  
Fine Print

Generalized dystonia occurs in 15 to 25% of persons with cerebral palsy (CP) and responds poorly to medical and surgical treatments. Object. After the authors observed a woman whose dystonic CP was dramatically improved by continuous infusion of intrathecal baclofen, they designed this pilot study to evaluate the effect of this treatment on a group of patients with dystonic CP. Methods. The authors assessed the short-term response to intrathecal baclofen infusion in 12 patients with dystonic CP. An intrathecal catheter was inserted percutaneously and connected to an external microinfusion pump. The infusion began at a rate of 100 µg/day and was increased by 50 µg every 12 hours until the dystonia abated, adverse effects occurred, or the dose reached 900 mg/day with no improvement. Two observers, one blinded and one not blinded to the patient's treatment status, viewed videotapes made before and after the infusions and graded the dystonia in eight body regions, using a 5-point scale. Overall and regional scores were compared by using Wilcoxon signed-rank tests. Conclusions. Dystonia diminished in 10 of 12 patients whose average daily dose of intrathecal baclofen was 575 µg. Overall dystonia scores and scores for the extremities, trunk, and cervical regions were significantly better after infusion (p = 0.003). The two observers' scores were not significantly different. Programmable infusion pumps were subsequently implanted in eight patients for long-term therapy and improvement was sustained in six (p < 0.05). Intrathecal baclofen infusion is a promising treatment option for generalized dystonia associated with CP. The effects of intrathecal baclofen infusion on dystonia can be evaluated by using short-term continuous infusions.

Prospective assessment of continuous intrathecal infusion of baclofen for spasticity caused by acquired brain injury: a preliminary report

1997 ◽  
Vol 87 (3) ◽  
pp. 415-419 ◽  
Author(s):  
Jay M. Meythaler ◽  
Anne McCary ◽  
Mark N. Hadley
Keyword(s):  
Brain Injury ◽  
Infusion Pump ◽  
Acquired Brain Injury ◽  
Intrathecal Baclofen ◽  
Intrathecal Administration ◽  
Content Type ◽  
Severe Spasticity ◽  
Prospective Assessment ◽  
Intrathecal Infusion ◽  
Fine Print

✓ Twelve consecutive patients with severe spasticity and hypertonia following acquired brain injury were treated with continuous intrathecal infusion of baclofen via an implanted, programmable infusion pump—catheter system for a minimum of 3 months. In every case intrathecal baclofen therapy resulted in a statistically significant reduction in upper- and lower-extremity tone, spasm frequency, and reflexes, contributing to improved functional abilities. There were no untoward side effects or complications associated with treatment. This preliminary assessment indicates that intrathecal administration of baclofen is effective in treating the disabling spasticity caused by acquired brain injury in selected patients.

Functional benefits and cost/benefit analysis of continuous intrathecal baclofen infusion for the management of severe spasticity

2002 ◽  
Vol 96 (6) ◽  
pp. 1052-1057 ◽  
Author(s):  
Fiona C. Sampson ◽  
Andrew Hayward ◽  
Gillian Evans ◽  
Richard Morton ◽  
Beverly Collett
Keyword(s):  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
Intrathecal Baclofen ◽  
Benefit Ratio ◽  
Content Type ◽  
Severe Spasticity ◽  
Life Years ◽  
Cost Benefit Ratio ◽  
The Cost ◽  
Fine Print

Object. Intrathecally delivered baclofen has been used as a treatment for severe spasticity since 1984. Despite this, there are uncertainties surrounding the benefits of treatment and the costs involved. The authors assessed the evidence of benefits and identified costs and the cost/benefit ratio for continuous intrathecal baclofen infusion in the treatment of severe spasticity. Methods. A systematic literature review was conducted to estimate the effect of continuous intrathecal baclofen infusion on function and quality-of-life (QOL) measures in patients with severe spasticity. Outcomes were related to standard QOL scores to estimate potential gains in quality-adjusted life years (QALYs). Information on the costs of continuous intrathecal baclofen infusion was obtained from hospitals in the United Kingdom. This information was combined to estimate the cost/benefit ratio for the use of continuous intrathecal baclofen infusion in patients with different levels of disability from severe spasticity. Studies indicate that bedbound patients are likely to improve their mobility and become able to sit out of bed. Patients with severe spasm-related pain are likely to have major improvement or complete resolution of this pain. Many other benefits are also reported. Such benefits are related to costs per QALY in the range of £6900 to £12,800 ($10,550–$19,570 US). Conclusions. In carefully selected patients who have not responded to less invasive treatments, continuous intrathecal baclofen infusion is likely to lead to worthwhile functional benefits. Continuous intrathecal baclofen infusion has an acceptable cost/benefit ratio compared with other interventions that are funded by the health service.

Intrathecal baclofen for spasticity of spinal origin: seven years of experience

1992 ◽  
Vol 77 (2) ◽  
pp. 236-240 ◽  
Author(s):  
Richard D. Penn
Keyword(s):  
Drug Delivery ◽  
Spinal Cord ◽  
Underlying Disease ◽  
Intrathecal Baclofen ◽  
Content Type ◽  
Severe Spasticity ◽  
Catheter System ◽  
To Receive ◽  
Fine Print

✓ A total of 66 consecutive patients with severe spasticity of spinal cord origin were screened with intrathecal baclofen, and all but two responded with a two-point decrease in their Ashworth spasticity scale and/or spasm scale score. Of these, 62 elected to receive chronic intrathecal baclofen administration by means of an implanted delivery system. These patients have been followed for an average of 30 months (the first three for 81 months). Intrathecal baclofen has been well tolerated and all serious side effects were transient and have been managed by dose adjustments. The pump presently available has worked safely; the only problem has been stalling in 7% of these devices. The catheter system has had to be repaired in just over one-half of the patients and is the main cause of interruption of drug delivery. Of the 62 patients implanted, 52 (84%) continue to be treated adequately for spasticity; there are three poor long-term responders, four deaths due to underlying disease, and three whose participation has been voluntarily withdrawn. It is suggested that long-term control of spinal spasticity by intrathecal baclofen can be achieved in most patients.

Intrathecally administered baclofen for treatment of children with spasticity of cerebral origin

1997 ◽  
Vol 87 (3) ◽  
pp. 409-414 ◽  
Author(s):  
Robert W. Armstrong ◽  
Paul Steinbok ◽  
D. Douglas Cochrane ◽  
Susan D. Kube ◽  
Susan E. Fife ◽  
...  
Keyword(s):  
Lower Limb ◽  
Muscle Tone ◽  
Intrathecal Baclofen ◽  
Double Blind ◽  
Content Type ◽  
Pump Operation ◽  
Leigh's Disease ◽  
Severe Spasticity ◽  
Spastic Quadriplegia ◽  
Fine Print

✓ Management of severe spasticity in children is often a difficult problem. Orally administered medications generally offer limited benefits. This study examines the value of intrathecally administered baclofen in the treatment of 19 children with severe spasticity of cerebral origin: eight of whom sustained brain injury associated with trauma, near drowning, or cardiac arrest; 10 with cerebral palsy (spastic quadriplegia); and one child with Leigh's disease. At the time of entry into the study, patients ranged from 4 to 19 years of age, and all were completely dependent on caretakers for activities of daily living. Children who responded positively to a trial dose of intrathecal baclofen underwent insertion of a drug delivery system for continuous infusion. This was followed by a double-blind trial of baclofen or placebo and follow-up review at 3 and 6 months, and yearly thereafter. Seven children did not undergo pump implantation because of excess sedation or poor response. The 12 remaining children have been followed for a period of 1 to 5 years. Favorable responses were present in all 12 children as determined by the Ashworth Scale, with the greatest benefit being reduction of lower limb tone. Except in the case of one child who had reduction in lower limb tone that resulted in difficulty with transfers, the caretakers all reported significant benefits from intrathecal baclofen, with improvement in muscle tone, behavior, sitting, and general ease of care being most commonly noted. Central side effects were seen in some children who received continuous intrathecal baclofen infusion and included hypotension (two patients), bradycardia (two), apnea or respiratory depression (two), and sedation (one). During a total of 568 months of pump operation there were 10 mechanical complications, including two related to pump or side port failure and eight related to catheter kinks, extrusions, or dislodgment. Pump pocket effusion occurred in five children and a cerebrospinal fluid fistula was seen in one child. Local infection occurred in three children and meningitis in two children. The results demonstrate the potential value of continuous intrathecal baclofen infusion for treatment of severe spasticity of cerebral origin. However, this treatment can result in significant complications and more experience is required before the long-term benefits can be determined.

Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin

2003 ◽  
Vol 98 (2) ◽  
pp. 291-295 ◽  
Author(s):  
A. Leland Albright ◽  
Richard Gilmartin ◽  
Dale Swift ◽  
Linda E. Krach ◽  
Cindy B. Ivanhoe ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lower Extremities ◽  
Intrathecal Baclofen ◽  
Term Treatment ◽  
Content Type ◽  
Severe Spasticity ◽  
Long Term Treatment ◽  
Upper And Lower Extremities ◽  
Fine Print

Object. The goal of this study was to ascertain the long-term effectiveness and safety of intrathecal baclofen (ITB) in the treatment of spasticity of cerebral origin in children and young adults. Methods. A prospective, multicenter study was conducted in 68 patients who had been enrolled in the initial evaluation of ITB therapy and were willing to participate in long-term surveillance. Seventy-three percent of the patients were younger than 16 years of age at the time of study entry. The patients were examined at least every 3 months and were observed for an average of 70 months. At each follow-up visit, spasticity in the upper and lower extremities was evaluated by applying Ashworth scores. All adverse events and complications were recorded on standardized data forms. Spasticity in both upper and lower extremities decreased significantly (p < 0.005) and remained decreased up to 10 years. The dosage of ITB increased from a mean of 157 (µg/day 3 months after pump insertion to 300 (µg/day at 2 years postimplantation, and remained relatively stable thereafter. There were no significant differences in ITB dosage in children of different ages. Adverse events potentially related to ITB therapy occurred in 50% of patients within 2 months after pump insertion and in 50% of patients thereafter; hypotonia and lethargy were the two most common adverse events. The most common complications of surgery were catheter-related problems (31%), seromas (24%), and cerebrospinal fluid leaks (15%). Conclusions. Intrathecal baclofen provides effective long-term treatment of spasticity of cerebral origin and its effects do not appear to diminish with time. This therapy is frequently associated with adverse side effects that usually can be alleviated by adjustments in dosage.

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

1999 ◽  
Vol 91 (5) ◽  
pp. 733-736 ◽  
Author(s):  
Barry Rawicki
Keyword(s):  
Continuous Infusion ◽  
Nursing Care ◽  
Intrathecal Baclofen ◽  
Content Type ◽  
Implantable Pump ◽  
Severe Spasticity ◽  
Long Term Follow Up ◽  
Fine Print

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.Conclusions. Long-term continuous infusion of intrathecal baclofen delivered via an implantable pump offers an effective method for dealing with otherwise intractable spasticity.

scholarly journals Brain Training and Sulforaphane Intake Interventions Separately Improve Cognitive Performance in Healthy Older Adults, Whereas a Combination of These Interventions Does Not Have More Beneficial Effects: Evidence from a Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 352
Author(s):  
Rui Nouchi ◽  
Qingqiang Hu ◽  
Toshiki Saito ◽  
Natasha Yuriko dos Santos Kawata ◽  
Haruka Nouchi ◽  
...  
Keyword(s):  
Older Adults ◽  
Active Control ◽  
Processing Speed ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Memory Performance ◽  
Brain Training ◽  
Beneficial Effects ◽  
Before And After ◽  
Double Blinded

Background: Earlier studies have demonstrated that a single-domain intervention, such as a brain-training (BT) game alone and a sulforaphane (SFN) intake, positively affects cognition. This study examined whether a combined BT and SFN intake intervention has beneficial effects on cognitive function in older adults. Methods: In a 12-week double-blinded randomized control trial, 144 older adults were randomly assigned to one of four groups: BT with SFN (BT-S), BT with placebo (BT-P), active control game (AT) with SFN (AT-S), and active control game with placebo (AT-P). We used Brain Age in BT and Tetris in AT. Participants were asked to play BT or AT for 15 min a day for 12 weeks while taking a supplement (SFN or placebo). We measured several cognitive functions before and after the intervention period. Results: The BT (BT-S and BT-P) groups showed more improvement in processing speed than the active control groups (AT-S and AT-P). The SFN intake (BT-S and AT-S) groups recorded significant improvements in processing speed and working memory performance unlike the placebo intake groups (BT-P and AT-P). However, we did not find any evidence of the combined intervention’s beneficial effects on cognition. Discussion: We discussed a mechanism to improve cognitive functions in the BT and SFN alone interventions.

Evaluation of endorphin content in the CSF of patients with trigeminal neuralgia before and after Gasserian ganglion thermocoagulation

1981 ◽  
Vol 55 (6) ◽  
pp. 935-937 ◽  
Author(s):  
Giuseppe Salar ◽  
Salvatore Mingrino ◽  
Marco Trabucchi ◽  
Angelo Bosio ◽  
Carlo Semenza
Keyword(s):  
Cerebrospinal Fluid ◽  
Trigeminal Neuralgia ◽  
Control Group ◽  
Gasserian Ganglion ◽  
Content Type ◽  
Group Of Seven ◽  
Idiopathic Trigeminal Neuralgia ◽  
Significant Difference ◽  
Before And After ◽  
Fine Print

✓ The β-endorphin content in cerebrospinal fluid (CSF) was evaluated in 10 patients with idiopathic trigeminal neuralgia during medical treatment (with or without carbamazepine) and after selective thermocoagulation of the Gasserian ganglion. These values were compared with those obtained in a control group of seven patients without pain problems. No statistically significant difference was found between patients suffering from trigeminal neuralgia and those without pain. Furthermore, neither pharmacological treatment nor surgery changed CSF endorphin values. It is concluded that there is no pathogenetic relationship between trigeminal neuralgia and endorphins.

Preoperative and postoperative cognitive functioning in patients with frontal meningiomas

2003 ◽  
Vol 98 (1) ◽  
pp. 21-31 ◽  
Author(s):  
Oliver Tucha ◽  
Christian Smely ◽  
Michael Preier ◽  
Georg Becker ◽  
Geraldine M. Paul ◽  
...  
Keyword(s):  
Executive Functions ◽  
Cognitive Functioning ◽  
Time Course ◽  
Lesion Size ◽  
Test Battery ◽  
Surgical Removal ◽  
Specific Information ◽  
Content Type ◽  
Before And After ◽  
Fine Print

Object. There is presently no specific information available concerning the nature and course of cognitive deficits caused by intracranial meningiomas. In this prospective study the authors examined the cognitive functioning of patients with frontal meningiomas. Methods. Fifty-four patients with frontal meningiomas were examined neuropsychologically before and after neurosurgery. The test battery consisted of standardized instruments including those assessing memory, attention, visuoconstructive abilities, and executive functions. The time period between pre-and postoperative assessment ranged from 4 to 9 months. The patients' performance was compared with the results in 54 healthy adults who were also assessed twice by using the same test battery in a period ranging from 4 to 9 months. In addition, the effect on cognition of meningioma lateralization, localization, lesion size, edema, brain compression, time course, and the occurrence of preoperative seizures was analyzed. Conclusions. Except in the case of working memory, comparisons of pre- and postoperative assessments of cognition revealed no differences in memory, visuoconstructive abilities, or executive functions, although a postoperative improvement in attentional functions was observed. The results of this study indicate that the surgical removal of frontal meningiomas does not impair patients' cognitive functioning. Furthermore, improvements in attentional functions may occur in these patients.

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