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.

Intrathecal Baclofen in Hereditary Spastic Paraparesis.

Introduction: Treatment with intrathecal baclofen (ITB) is a therapeutic option in the management of severe spasticity in patients with hereditary spastic paraparesis (HSP). However, information on the impact of ITB on the natural course of disease, especially the effect of ITB on functional parameters over time is limited. Materials and Methods: We evaluated seven patients with HSP retrospectively who were treated with an ITB device. The following parameters were measured before (pre-implantation) and after implantation (post-implantation) of the ITB device at steady state dosage of ITB and annually until last follow-up: modified Ashworth Scale, Reflex Scale, modified Rankin Scale, and Rivermead Mobility Index. The ITB dosages were assessed after reaching steady state as well as annually until last follow-up. Results: The ITB device was implanted 13 ± 6 (range 9-16) years after diagnosis of HSP on average. Severe spasticity was controlled in all patients by a mean baclofen dosage of 188 ± 60 (range 145-230) µg per day at steady state post-implantation. The modified Ashworth Scale improved significantly from 3 (interquartile range [IQR] 3-3.25) to 1 (IQR 1-1.25; p = 0.046), as did the Reflex Scale from 5 (IQR 4.75-5) to 3 (IQR 2.75-3; p = 0.046) at steady state dosage of ITB. The modified Rankin Scale improved from 2 (IQR 2-2) to 1 (IQR 1-1.5; p = 0.083) and the Rivermead Mobility Index remained 14 (IQR 13.5-14 pre-implantation, IQR 14-14 post-implantation; p = 0.18). Post-implantation, spasticity improved for 2-3 years, followed by a stable phase of ambulatory and other mobility functions for 4-5 years. Thereafter, the maintenance or progressive loss of mobility depended on individual courses of the disease. No ITB-related severe side effects occurred. Discussion: Our data further support the role of ITB in the treatment of severe spasticity in patients with deteriorated walking performance suffering HSP. ITB therapy may initially improve spasticity and stabilize mobility functions for the first 6-8 years in patients with HSP.

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.