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Grafting of C7 from the nonparalyzed to the paralyzed side in patients with arm paralysis resulted in greater improvements in power, spasticity, and function at 12 months than rehabilitation therapy alone, and functional connection to the ipsilateral cerebral hemisphere developed.

Spasticity is a major determinant of disability and decline in quality of life in patients with motor neuron disease. Cannabinoids have been approved for symptomatic treatment of spasticity in multiple sclerosis. We investigated whether cannabinoids might also reduce spasticity in patients with motor neuron disease. We did an investigator-initiated, randomised, double-blind, placebo-controlled, phase 2 clinical trial at four tertiary motor neuron disease centres in Italy. Eligible patients were aged 18–80 years; had possible, laboratory-supported probable, probable, or definite amyotrophic lateral sclerosis as defined by revised El Escorial criteria, or primary lateral sclerosis according to Pringle's criteria; had spasticity symptoms due to motor neuron disease for at least 3 months; had spasticity scores of 1 or greater in at least two muscle groups on the Modified Ashworth Scale; and were taking an antispasticity regimen that was maintained at a stable dose for 30 days before enrolment. Participants were assigned (1:1) by an independent statistician via a computer-generated randomisation sequence to a standardised oromucosal spray (nabiximols) containing a defined combination of delta-9-tetrahydrocannabinol and cannabidiol (each 100 μL actuation contained 2·7 mg delta-9-tetrahydrocannabinol and 2·5 mg cannabidiol) or to placebo for 6 weeks. Participants self-titrated during the first 14 treatment days according to a predefined escalation scheme (maximum 12 actuations per 24 h), then maintained that dose for 4 weeks. The primary endpoint was the change in the score on the Modified Ashworth Scale, which was assessed at baseline and after 6 weeks. Safety and tolerability were also monitored. Participants, investigators, site personnel, and the study statistician were masked to treatment allocation. All randomised participants who received at least one dose of study drug were included in the analysis. This trial is registered with ClinicalTrials.gov, number NCT01776970. The trial is closed to new participants with follow-up completed. Between Jan 19, 2013, and Dec 15, 2014, 60 participants were randomly assigned, and 59 participants were included in the final analysis (29 in the nabiximols group and 30 in the placebo group). Modified Ashworth Scale scores improved by a mean of 0·11 (SD 0·48) in the nabiximols group and deteriorated by a mean of 0·16 (0·47) in the placebo group (adjusted effect estimate −0·32 [95% CI −0·57 to −0·069]; p=0·013). Nabiximols was well tolerated, and no participants withdrew from the double-blind phase of the study. No serious adverse effects occurred. In this proof-of-concept trial, nabiximols had a positive effect on spasticity symptoms in patients with motor neuron disease and had an acceptable safety and tolerability profile. These findings should be investigated further in larger clinical trials. Italian Research Foundation for Amyotrophic Lateral Sclerosis.

Objectives: This study is a retrospective investigation of the effects of repetitive botulinum toxin A therapy (BoNT-A) and intensive rehabilitation (IR) on lower limb spasticity in post-stroke patients. Methods: Thirty-five post-stroke patients was included in this study and received BoNT-A for the first time. A 12-day inpatient protocol was with 4 cycles of the treatment protocol. The severity of spasticity, motor function and brace status were evaluated. Results: The modified Ashworth Scale (MAS) score of ankle dorsiflexors, range of motion, walking speed and balancing ability were significantly improved after cycle 1. The improvement of spasticity and motor function was persistent through cycles 2–4. One-third of brace users were able to discontinue the use of a brace. All of these brace users showed a forward gait pattern prior to therapy. Conclusions: Repeated BoNT-A combined with IR improved lower limb spasticity in post-stroke patients. Our results suggest that patients who show the forward gait pattern prior to therapy may be able to discontinue the use of their brace after therapy.

Resistance from antagonistic muscle groups might be a crucial factor reducing function in chronic hemiparesis. The resistance due to spastic co-contraction might be reduced by botulinum toxin injections. We assessed the effects of abobotulinumtoxinA injection in the upper limb muscles on muscle tone, spasticity, active movement, and function. In this randomised, placebo-controlled, double-blind study, we enrolled adults (aged 18–80 years) at least 6 months after stroke or brain trauma from 34 neurology or rehabilitation clinics in Europe and the USA. Eligible participants were randomly allocated in a 1:1:1 ratio with a computer-generated list to receive a single injection session of abobotulinumtoxinA 500 U or 1000 U or placebo into the most hypertonic muscle group among the elbow, wrist, or finger flexors (primary target muscle group [PTMG]), and into at least two additional muscle groups from the elbow, wrist, or finger flexors or shoulder extensors. Patients and investigators were masked to treatment allocation. The primary endpoint was the change in muscle tone (Modified Ashworth Scale [MAS]) in the PTMG from baseline to 4 weeks. Secondary endpoints were Physician Global Assessment (PGA) at week 4 and change from baseline to 4 weeks in the perceived function (Disability Assessment Scale [DAS]) in the principal target of treatment, selected by the patient together with physician from four functional domains (dressing, hygiene, limb position, and pain). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT01313299. 243 patients were randomly allocated to placebo (n=81), abobotulinumtoxinA 500 U (n=81), or abobotulinumtoxinA 1000 U (n=81). Mean change in MAS score from baseline at week 4 in the PTMG was −0·3 (SD 0·6) in the placebo group (n=79), −1·2 (1·0) in the abobotulinumtoxinA 500 U group (n=80; difference −0·9, 95% CI −1·2 to −0·6; p<0·0001 vs placebo), and −1·4 (1·1) in the abobotulinumtoxinA 1000 U group (n=79; −1·1, −1·4 to −0·8; p<0·0001 vs placebo). Mean PGA score at week 4 was 0·6 (SD 1·0) in the placebo group (n=78), 1·4 (1·1) in the abobotulinumtoxinA 500 U group (n=80; p=0·0003 vs placebo), and 1·8 (1·1) in the abobotulinumtoxinA 1000 U group (n=78; p<0·0001 vs placebo). Mean change from baseline at week 4 in DAS score for the principal target of treatment was −0·5 (0·7) in the placebo group (n=79), −0·7 (0·8) in the abobotulinumtoxinA 500 U group (n=80; p=0·2560 vs placebo), and −0·7 (0·7) in the abobotulinumtoxinA 1000 U group (n=78; p=0·0772 vs placebo). Three serious adverse events occurred in each group and none were treatment related; two resulted in death (from pulmonary oedema in the placebo group and a pre-existing unspecified cardiovascular disorder in the abobotulinumtoxinA 500 U group). Adverse events that were thought to be treatment related occurred in two (2%), six (7%), and seven (9%) patients in the placebo, abobotulinumtoxinA 500 U, and abobotulinumtoxinA 1000 U groups, respectively. The most common treatment-related adverse event was mild muscle weakness. All adverse events were mild or moderate. AbobotulinumtoxinA at doses of 500 U or 1000 U injected into upper limb muscles provided tone reduction and clinical benefit in hemiparesis. Future research into the treatment of spastic paresis with botulinum toxin should use active movement and function as primary outcome measures. Ipsen.

To investigate the efficacy of repetitive transcranial magnetic stimulation (rTMS) for managing upper limb muscular spasticity after stroke, and to examine its therapeutic effects on spasticity and motor function in the upper limb. A total of 110 post-stroke patients with upper limb spasticity were randomly assigned to the experimental or the control group. The experimental group received rTMS in conjunction with conventional rehabilitation therapy. The affected side of the head received daily treatment for 20 min each at Erb’s point and the stimulation point, totaling 15 sessions over six days per week. The stimulation frequencies were 10 Hz (high frequency, M1 region) and 1 Hz (low frequency, Erb’s point), with an intensity at 120% of the threshold. The control group received sham stimulation alongside conventional rehabilitation therapy. Assessments including the Modified Ashworth Scale (MAS) and Fugl-Meyer Assessment for Upper Extremity (FM-UE), were also conducted before treatment initiation and after 15 rounds of rTMS. Post hoc subgroup analyses were conducted using independent-sample t -tests for FM-UE scores and Mann-Whitney U tests for MAS scores to assess heterogeneity in treatment responses by stroke type (cerebral infarction vs. intracerebral hemorrhage). Among these 110 patients, 25 patients were excluded from the study for various reasons. Hence, 53 patients were included in the control group and 32 patients were included in the experimental group. Following 15 rounds of rTMS, the experimental group exhibited a reductions in MAS score ( P  = 0.004). FM-UE scores increased significantly in both groups (both P  < 0.05), with significant improvement observed in the experimental group ( P  < 0.05). Subgroup analyses revealed no significant differences in FM-UE or MAS outcomes between stroke types, likely due to the limited sample size of intracerebral hemorrhage participants (experimental group: n  = 8; control group: n  = 16). rTMS effectively alleviates upper limb spasticity and enhances motor function after stroke by modulating cortical and spinal nerve excitability.

Even though robotic rehabilitation is very useful to improve motor function, there is no conclusive evidence on its role in reducing post-stroke spasticity. Focal muscle vibration (MV) is instead very useful to reduce segmental spasticity, with a consequent positive effect on motor function. Therefore, it could be possible to strengthen the effects of robotic rehabilitation by coupling MV. To this end, we designed a pilot randomized controlled trial (Clinical Trial NCT03110718) that included twenty patients suffering from unilateral post-stroke upper limb spasticity. Patients underwent 40 daily sessions of Armeo-Power training (1 hour/session, 5 sessions/week, for 8 weeks) with or without spastic antagonist MV. They were randomized into two groups of 10 individuals, which received (group-A) or not (group-B) MV. The intensity of MV, represented by the peak acceleration (a-peak), was calculated by the formula (2πf)2A, where f is the frequency of MV and A is the amplitude. Modified Ashworth Scale (MAS), short intracortical inhibition (SICI), and Hmax/Mmax ratio (HMR) were the primary outcomes measured before and after (immediately and 4 weeks later) the end of the treatment. In all patients of group-A, we observed a greater reduction of MAS (p = 0.007, d = 0.6) and HMR (p<0.001, d = 0.7), and a more evident increase of SICI (p<0.001, d = 0.7) up to 4 weeks after the end of the treatment, as compared to group-B. Likewise, group-A showed a greater function outcome of upper limb (Functional Independence Measure p = 0.1, d = 0.7; Fugl-Meyer Assessment of the Upper Extremity p = 0.007, d = 0.4) up to 4 weeks after the end of the treatment. A significant correlation was found between the degree of MAS reduction and SICI increase in the agonist spastic muscles (p = 0.004). Our data show that this combined rehabilitative approach could be a promising option in improving upper limb spasticity and motor function. We could hypothesize that the greater rehabilitative outcome improvement may depend on a reshape of corticospinal plasticity induced by a sort of associative plasticity between Armeo-Power and MV.

This randomized controlled clinical trial investigated the effects of gastrocnemius functional massage (GFM) combined with neurodevelopmental treatment (NDT) on spasticity, gait parameters, and functional mobility in stroke patients. A total of 28 chronic stroke survivors were randomized into an experimental group (EG, n = 13) and a control group (CG, n = 15). Both groups received NDT twice a week for six weeks, while the EG received additional GFM. Spasticity (Modified Ashworth Scale), gait parameters (LegSys), and functional mobility (Timed Up and Go test) were assessed pre- and post-treatment. The results showed significant improvements in spasticity within the EG for the hip adductor (p = 0.002), knee extensor (p = 0.006), and ankle plantar flexor muscles (p = 0.002), compared to minimal changes in the CG (p > 0.05). Gait analysis revealed significant improvements in the EG for stride number (p = 0.0001), stride length (p = 0.006), stride time (p = 0.001), and stride velocity (p = 0.002), whereas the CG showed no significant changes (p > 0.05). Functional mobility improvements in the EG included reduced sit-to-stand time (p = 0.021) and total Timed Up and Go time (p = 0.001), indicating enhanced dynamic balance and lower extremity strength. These findings suggest that combining GFM with NDT significantly enhances spasticity reduction, gait parameters, and functional mobility in stroke patients. Future studies are needed to explore the long-term effects and underlying mechanisms of this combined approach. This study was registered at www.clinicaltrials.gov under the identification number NCT06265753.

Spasticity is a common and poorly controlled symptom of multiple sclerosis. Our objective was to determine the short-term effect of smoked cannabis on this symptom. We conducted a placebo-controlled, crossover trial involving adult patients with multiple sclerosis and spasticity. We recruited participants from a regional clinic or by referral from specialists. We randomly assigned participants to either the intervention (smoked cannabis, once daily for three days) or control (identical placebo cigarettes, once daily for three days). Each participant was assessed daily before and after treatment. After a washout interval of 11days, participants crossed over to the opposite group. Our primary outcome was change in spasticity as measured by patient score on the modified Ashworth scale. Our secondary outcomes included patients' perception of pain (as measured using a visual analogue scale), a timed walk and changes in cognitive function (as measured by patient performance on the Paced Auditory Serial Addition Test), in addition to ratings of fatigue. Thirty-seven participants were randomized at the start of the study, 30 of whom completed the trial. Treatment with smoked cannabis resulted in a reduction in patient scores on the modified Ashworth scale by an average of 2.74 points more than placebo (p < 0.0001). In addition, treatment reduced pain scores on a visual analogue scale by an average of 5.28 points more than placebo (p = 0.008). Scores for the timed walk did not differ significantly between treatment and placebo (p = 0.2). Scores on the Paced Auditory Serial Addition Test decreased by 8.67 points more with treatment than with placebo (p = 0.003). No serious adverse events occurred during the trial. Smoked cannabis was superior to placebo in symptom and pain reduction in participants with treatment-resistant spasticity. Future studies should examine whether different doses can result in similar beneficial effects with less cognitive impact.

Background Post-stroke spasticity (PSS) in the ankle plantar flexors leads to abnormal gait, increased energy expenditure, and a higher risk of falls. Ultrasonographic measures, such as muscle fascicle length (MFL) and pennation angle (PA), provide insight into muscle changes associated with spasticity. This study aimed to investigate the dose-dependent effects of focused extracorporeal shockwave therapy (ESWT) on ultrasonographic muscle properties and clinical outcomes in patients with PSS of the ankle plantar flexors. Methods This post hoc analysis was based on a double-blind, randomized controlled trial investigating different ESWT doses for post-stroke ankle spasticity treatment. A total of 39 patients with PSS of the ankle plantar flexors were randomized into two groups: the double-dose ESWT group received 4,000 focused shockwave pulses per session, while the control ESWT group received 2,000 pulses per session. Both groups received four ESWT sessions over a two-week intervention period, followed by a 24-week follow-up period for outcome assessments. Outcome measures included ultrasonographic assessments of MFL, PA, and strain elastography, as well as clinical evaluations using the Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS), passive range of motion (PROM), Timed Up and Go (TUG) test, and Barthel Index at baseline, and at 1, 4, 12, and 24 weeks post-treatment. Results No significant within-group changes in PA or MFL were observed for either ESWT group over the 24-week period. Generalized estimation equation analysis showed no significant group effects on PA, MFL, or strain elastography. However, when analyzing all participants, a significant time-related improvement in MFL was identified. In the double-dose ESWT group, MFL was significantly correlated with MTS, PROM, and TUG test, while PA was significantly correlated with MAS. Given that this was a post hoc analysis, these results should be interpreted conservatively. Conclusions While PA and MFL did not show significant differences between groups, the double-dose ESWT group exhibited improved clinical outcomes linked to MFL. These findings suggest that increased ESWT dosage may enhance muscle architecture and function in stroke rehabilitation.

Stroke is the principal cause of permanent disability in adult age, and many patients require lifelong medical treatment and care from others for their daily activities. It has enormous repercussions on the work and social lives of patients and their families and involves major economic expenditure. Post-stroke spastic upper limb is usually treated with rehabilitation, occupational therapy, and periodical injections of botulinum toxin, while surgical correction is now seldom considered. However, there has been no clinical trial to compare between surgical and toxin treatments. The primary aim of this study is to compare outcomes between surgery and a conventional approach with botulinum toxin in patients with post-stroke upper limb spasticity. A two-arm (surgical treatment [n = 22] vs. botulinum toxin [n = 22]) randomized clinical trial (RCT) will be performed to compare the efficacy of surgery with that of botulinum toxin treatment in patients with post-stroke upper limb spasticity. Data will be collected at baseline and at 6 and 12 months of follow-up on functionality, hygienic status, quality of life, sleep quality, anxiety/depression levels, and functional magnetic resonance imaging (fMRI)-measured brain activity. Healthcare and care costs will be compared between the groups. This research is set in the context of chronic diseases, aging, and functional/mobility limitations. The results can be expected to have a major impact, because the high prevalence of stroke and the severe associated disability means that an enormous number of patients can benefit from improved treatment protocols, and a more rational use of resources would yield considerable economic benefits for health and care systems. Our expectation is that outcomes would be more favorable with surgery. However, the aim is not to exclude any approach but rather to explore how the potential and indications of each treatment could be integrated within a multidisciplinary therapeutic protocol in a complementary manner. Trial Registration: ClinicalTrials.gov (NCT06392633). Registered on 30 April 2024.