Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration.

OBJECTIVE: To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation. DESIGN: Retrospective open label study. Mean duration of follow-up 64 months. SETTING: Primary-care and referral center, ambulatory and hospitalized care. PARTICIPANTS: Patients (N=116) undergoing continuous ITB trials between 2006 and 2017. INTERVENTIONS: Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump. MAIN OUTCOME MEASURES: Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events. RESULTS: A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up. CONCLUSIONS: Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events.

On the recovery of disorders of consciousness under intrathecal baclofen administration for severe spasticity-An observational study.

BACKGROUND: Occasionally, patients show dramatic recovery from disorders of consciousness (DOC) under intrathecal baclofen (ITB), an established treatment option for severe supraspinal spasticity. Anecdotal explanations for ITB-related recovery of cognition include modulation of afferent impulses at the spinal level, thereby reducing spasticity-related proprioceptive information overload within cortico-thalamo-cortical connections. OBJECTIVE: In this retrospective patient chart analysis, we assessed whether a reduction in spasticity would be associated with an increase in Coma Recovery Scale revised (CRS-R) scores in a larger sample of patients than previously published. METHODS: From a hospital-based ITB treatment register, we extracted data from 26 patients with DOC and severe supraspinal spasticity who improved by >2 points on the Coma Recovery Scale revised (CRS-R) within 6 months after ITB treatment initiation. We assessed Modified Ashworth scale (MAS) scores and CRS-R scores on admission (PRE) and 3 and 6 months after initiation of ITB treatment (3M, 6M). We performed correlation analysis of the scores and their respective changes (PRE to 3M, 3M to 6M). We also correlated the time from acute event until ITB initiation to CRS-R scores at 3M and 6M. RESULTS: ITB led to significant improvement in spasticity based on MAS scores, which did not correlate to the improvements seen in CRS-R total and subscale scores. Daily ITB dose did neither correlate to MAS scores nor to CRS-total scores in the whole patient group, but after 3 months, ITB dose correlated to some CRS-R subscale scores in some patient subgroups. Time until ITB treatment did not correlate to CRS-R scores later on. CONCLUSIONS: Our data confirm that ITB may exert beneficial effects in selected DOC patients with respect to improved cognitive functions, which, however, do not correlate to its antispastic effect. The lack of correlation between time to ITB and CRS-R outcome, but significant CRS-R improvements following pump implantation, renders spontaneous remissions unlikely and leaves room for alternative pharmacological mechanisms.

Complications After Dual Placement of a Baclofen Pump and Ventricular Shunt in Individuals With Severe Brain Injury.

OBJECTIVE: To assess the complications of dual placement of an intrathecal baclofen (ITB) pump and a ventriculoperitoneal shunt (VPS) in people with severe brain injury. DESIGN: Case series. SETTING: Referral center, ambulatory, and hospitalized care. PARTICIPANTS: Referred sample (N=9) composed of 5 men and 4 women with severe brain injuries (5 traumatic brain injuries, 3 subarachnoid hemorrhages, 1 intracerebral hemorrhage) and a mean disease duration of 6±4.5 years (range, 0.5-11.4y). INTERVENTION: Both systems (ie, an ITB device and a VPS system) were implanted in all participants. MAIN OUTCOME MEASURES: We assessed the number and type of complications that occurred after implantation of the second system, as well as subsequent interventions. RESULTS: The ITB delivery system was implanted after the VPS system in 5 patients (ITB group), and the VPS system was the second implanted system in 4 groups (VPS group). Seven complications occurred in 7 patients after implantation of the second system, 4 in the ITB group and 3 in the VPS group. Three of the complications were drug-related, 2 were procedure-related, and 2 were device-related. The complication occurred within 4 days after implantation of the second system in 6 patients. CONCLUSIONS: Complications are frequent in patients who undergo implantation of both an ITB delivery device and a VPS system. Drug-related complications were more common. Complications occurred more often when an ITB device was implanted as the second system. The critical period is the first 4 days.