scholarly journals P.037 Benefits of Treatment with OnabotulinumtoxinA in Naive and Non-naive Patients with Cervical Dystonia are Sustained over Time in CD PROBE

Author(s):  
P Agarwal ◽  
M Schwartz ◽  
A Zuzek ◽  
A Patel

Background: The sustained effects of onabotulinumtoxinA in patients with cervical dystonia (CD) who were naïve or non-naïve to botulinum toxin at enrollment in CD PROBE (CD Patient Registry for Observation of BOTOX® Efficacy) were evaluated. Methods: Patients were included if they completed all three treatment cycles and had accompanying data in this prospective, observational study. Assessments included CD severity, Cervical Dystonia Impact Profile (CDIP-58), Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), treatment interval, total dose, and adverse events (AEs). Results: Changes in severity following each onabotulinumtoxinA treatment were generally similar between naïve (n=212) and non-naïve (n=138) patients. Severity scores were maintained or improved in most patients with mild/moderate symptoms, while 30.0-66.7% with the highest severity scores shifted to a lower score across treatments. Sustained improvements were seen in all CDIP-58 subscales and TWSTRS total scores irrespective of baseline CD severity and toxin status. The median time interval between injections was similar in naïve (93.0–98.0 days) and non-naïve patients (96.0–97.0 days); doses tended to be lower in naïve patients. The most common AEs (dysphagia, muscular weakness) were similar. Conclusions: CD severity was attenuated by repeat onabotulinumtoxinA treatments at consistent intervals regardless of prior botulinum toxin exposure. Treatments were well tolerated.

2018 ◽  
Vol 75 (10) ◽  
pp. 1035-1040
Author(s):  
Ivona Stankovic ◽  
Hristina Colovic ◽  
Vesna Zivkovic ◽  
Jelena Stamenovic ◽  
Anita Stankovic ◽  
...  

Background/Aim. Botulinum toxin is a basic, recommended method of treatment in controlling cervical dystonia (CD). Physical therapy has limited effect due to the nature of the disease that is a result of a disorder in structures and relationships of the basal ganglia. The aim of this study was to analyze the effect of physical therapy applied as monotherapy, or with parallel application of botulinum toxin in patients with CD. Methods. Randomized controlled clinical pilot study included 14 patients diagnosed with idiopathic CD. All patients were initially assessed by using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Torticollis Rating Scale (Tsui scale). In the control group, composed of 5 patients, the treatment included only physical therapy. The experimental group (9 patients) was first given botulinum toxin, and physical therapy was applied after five days. Physical therapy was conducted five times a week in the period of two weeks at the Clinic. Patients of both groups were instructed to continue with the physical therapy at home. The effects of treatment were analyzed after 1, 3 and 6 months using TWSTRS and Tsui scale. Results. At the beginning of the investigation, the differences in TWSTRS and Tsui scale between the groups were not significant. In the control group, after 1 month, significant improvement was achieved in all three parts of the TWSTRS. After 3 and 6 months, the effects of physical therapy were reduced to control levels. In the experimental group, highly significant increase of all parameters of TWSTRS was noted after 1, 3 and 6 months. In the control group, highly significant decrease of changes in Tsui scale was noticed only after one month while in the experimental group, it was maintained after 3 and 6 months. Conclusion. Application of physical therapy provides a significant improvement in disease severity, but the effect is better and of longer duration when combined with the botulinum toxin.


2019 ◽  
Vol LI (1) ◽  
pp. 25-31 ◽  
Author(s):  
Zifa G Khaiatova ◽  
Zuleikha A Zalyalova

The study included 54 patients with cranio-cervical dystonia, 38 (70.4%) of whom were women, 16 (29.6%) - men, mean age 49,8 ± 11,3 years. 32 patients were diagnosed with cervical dystonia, groups with blepharospasm and Meige’s syndrome included 11 patients respectively. All patients were screened by «Unified Dystonia Rating Scale» and those who had cervical dystonia also by «Toronto western spasmodic torticollis rating scale (TWSTRS)». Psychoemotional state in these patients was examined by Beck depression inventory (BDI) and Hamilton’s anxiety rating scale (HAM-A). Depression and anxiety occurrence and severity was evaluated, impact of different factors including Botulinum toxin treatment was observed. Results of the study confirmed that anxiety and depressive disorders are associated with craniocervical dystonia. Sex, localization of dystonia, disease duration, and satisfaction with the treatment do not affect significantly severity of anxiety and depression. Regular injections of Botulinum toxin significantly decrease severity of psychoemotional disorders in these patients.


2014 ◽  
Vol 72 (6) ◽  
pp. 405-410 ◽  
Author(s):  
Roberta Weber Werle ◽  
Sibele Yoko Mattozo Takeda ◽  
Marise Bueno Zonta ◽  
Ana Tereza Bittencourt Guimarães ◽  
Hélio Afonso Ghizoni Teive

Objective : Describe the functional, clinical and quality of life (QoL) profiles in patients with cervical dystonia (CD) with residual effect or without effect of botulinum toxin (BTX), as well as verify the existence of correlation between the level of motor impairment, pain and QoL. Method : Seventy patients were assessed through the Craniocervical dystonia questionnaire-24 (CDQ-24) and the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Results : The greater the disability, pain and severity of dystonia, the worse the QoL (p<0.0001). Greater severity relates to greater disability (p<0.0001). Pain was present in 84% of the sample, being source of disability in 41%. The most frequent complaints were: difficulty in keeping up with professional and personal demands (74.3%), feeling uneasy in public (72.9%), hindered by pain (68.6%), depressed, annoyed or bitter (47.1%), lonely or isolated (32.9%). Conclusion : The physical, social and emotional aspects are the most affected in the QoL of these patients.


2011 ◽  
Vol 69 (6) ◽  
pp. 900-904 ◽  
Author(s):  
Mariana Ribeiro Queiroz ◽  
Hsin Fen Chien ◽  
Egberto Reis Barbosa

OBJECTIVE: The purpose of this study was to evaluate quality of life (QoL) in a Brazilian population of individuals with cervical dystonia (CD) without effect of botulinum toxin (BTx) or with only residual effect of BTx, and identify possible physical and social aspects that affect their QoL. METHOD: Sixty five out of sixty seven consecutive patients with CD were assessed with two instruments: Short-form Health Survey with 36 questions (SF-36) and Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). RESULTS: Severity of CD (TWSTRS) correlated moderately with two SF-36 subscale: role-physical (r= -0.42) and body pain (r= -0.43). Women also scored worse in two subscale of SF-36: vitality (p<0.05) and mental-health (p<0.005). CONCLUSION: Severity of CD and gender (female) were the main factors related to a worse QoL perception. These findings may help health professionals to predict which characteristics could lead to worse QoL, and therefore, better target their interventions to lessen the burden caused by CD.


Neurosurgery ◽  
2010 ◽  
Vol 67 (4) ◽  
pp. 957-963 ◽  
Author(s):  
Francesco Cacciola ◽  
Jibril Osman Farah ◽  
Paul R Eldridge ◽  
Patricia Byrne ◽  
Telekath K Varma

Abstract BACKGROUND: Bilateral globus pallidus internus (GPi) deep brain stimulation (DBS) was shown to be effective in cervical dystonia refractory to medical treatment in several small short-term and 1 long-term follow-up series. Optimal stimulation parameters and their repercussions on the cost/benefit ratio still need to be established. OBJECTIVE: To report our long-term outcome with bilateral GPi deep brain stimulation in cervical dystonia. METHODS: The Toronto Western Spasmodic Torticollis Rating Scale was evaluated in 10 consecutive patients preoperatively and at last follow-up. The relationship of improvement in postural severity and pain was analyzed and stimulation parameters noted and compared with those in a similar series in the literature. RESULTS: The mean (standard deviation) follow-up was 37.6 (16.9) months. Improvement in the total Toronto Western Spasmodic Torticollis Rating Scale score as evaluated at latest follow-up was 68.1% (95% confidence interval: 51.5-84.6). In 4 patients, there was dissociation between posture severity and pain improvement. Prevalently bipolar stimulation settings and high pulse widths and amplitudes led to excellent results at the expense of battery life. CONCLUSION: Improvement in all 3 subscale scores of the Toronto Western Spasmodic Torticollis Rating Scale with bilateral GPi deep brain stimulation seems to be the rule. Refinement of stimulation parameters might have a significant impact on the cost/benefit ratio of the treatment. The dissociation of improvement in posture severity and pain provides tangible evidence of the complex nature of cervical dystonia and offers interesting insight into the complex functional organization of the GPi.


2004 ◽  
Vol 17 (1) ◽  
pp. 32-38 ◽  
Author(s):  
Zelma H. T. Kiss ◽  
Kristina Doig ◽  
Michael Eliasziw ◽  
Ranjiit Ranawaya ◽  
Oksana Suchowersky

Object Deep brain stimulation (DBS) of the globus pallidus internus (GPi) is beneficial for generalized dystonia and has been proposed as a treatment for cervical dystonia. The Canadian Stereotactic/Functional and Movement Disorders Groups designed a pilot project to investigate the following hypothesis: that bilateral DBS of the GPi will reduce the severity of cervical dystonia at 1 year of follow up, as scored in a blinded fashion by two neurologists using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS). Secondary outcome measures included pain and disability subscores of the TWSTRS, Short Form–36 quality of life index, and the Beck Depression Inventory. Methods Three patients have undergone surgery in Calgary with a followup duration of 7.4 ± 5.9 months (mean ± standard deviation). One patient underwent inadvertent ineffective stimulation for the first 3 months and did not experience a benefit until DBS programming was corrected. All three patients had rapid response to stimulation, with the muscles relaxing immediately and abnormal movements improving within days. Total TWSTRS scores improved by 79%, and severity subscores improved significantly, from 15.7 ± 2.1 to 7.7 ± 2.9 (paired ttest, p = 0.02). Pain and disability subscores improved from 25.5 ± 4.1 to 3.3 ± 3.1 (paired ttest, p = 0.002) and from 13.3 ± 4.9 to 3.3 ± 4.2 (paired ttest, p = 0.06), respectively. Conclusions Although it is too early to reach broad conclusions, this report of preliminary results confirms the efficacy of DBS of the GPi for cervical dystonia.


2019 ◽  
Vol 26 (9) ◽  
pp. 560-567
Author(s):  
Avram Fraint ◽  
Glenn T. Stebbins ◽  
Gian Pal ◽  
Cynthia L. Comella

Introduction Telemedicine is used successfully for evaluating patients with neurologic diseases, but has not been tested in cervical dystonia (CD). CD is uniquely suited for telemedicine as the scales validated to assess its severity rely only on visual inspection. The study sought to determine reliability, feasibility and satisfaction of telemedicine visits for evaluating CD. Methods Patients 18 years and older with a diagnosis of CD and scheduled for botulinum toxin (BoNT) injections were recruited, with a total of 46 enrolled. Dystonia severity was evaluated using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) motor severity subscale. Three total evaluations took place: an initial telemedicine evaluation on the day prior to a scheduled BoNT injection; an in-person evaluation in clinic immediately before injections; and a follow-up telemedicine visit 4–6 weeks after injection with subsequent completion, by both participants and the clinician, of satisfaction questionnaires. Agreement between telemedicine and in-person TWSTRS data was calculated using intra-class correlation coefficients (ICC) and kappa statistics where appropriate. Feasibility was determined by the percent of patients completing all three visits, and satisfaction with telemedicine visits was determined based on answers to satisfaction questionnaires. Results There was excellent agreement between visit types for the TWSTRS motor severity summary score (κ = 0.890; 95th CI 0.713; 0.949). Only two individual TWSTRS items failed to meet the threshold for moderate agreement. Feasibility and satisfaction were high. Discussion Telemedicine is reliable and feasible in the evaluation of CD. Some CD patients would prefer telemedicine visits. Participants and the clinician were satisfied with telemedicine visits.


2020 ◽  
Vol 33 (5) ◽  
pp. 658-666
Author(s):  
Yijie Lai ◽  
Peng Huang ◽  
Chencheng Zhang ◽  
Liangyun Hu ◽  
Zhengdao Deng ◽  
...  

OBJECTIVESelective peripheral denervation (SPD) is a widely accepted surgery for medically refractory cervical dystonia (CD), but when SPD has failed, the available approaches are limited. The authors investigated the results from a cohort of CD patients treated with unilateral pallidotomy after unsatisfactory SPD.METHODSThe authors retrospectively analyzed patients with primary CD who underwent unilateral pallidotomy after SPD between April 2007 and August 2019. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to evaluate symptom severity before surgery, 7 days postsurgery, 3 months postsurgery, and at the last follow-up. TWSTRS subscores for disability and pain and the 24-item Craniocervical Dystonia Questionnaire (CDQ-24) were used to assess quality of life.RESULTSAt a mean final follow-up of 5 years, TWSTRS severity subscores and total scores were significantly improved (n = 12, mean improvement 57.3% and 62.3%, respectively, p = 0.0022 and p = 0.0022), and 8 of 12 patients (66.7%) were characterized as responders (improvement ≥ 25%). Patients with rotation symptoms before pallidotomy showed greater improvement in TWSTRS severity subscores than those who did not (p = 0.049). The most common adverse event was mild upper-limb weakness (n = 3). Patients’ quality of life was also improved.CONCLUSIONSUnilateral pallidotomy seems to offer an effective and safe option for patients with CD who have otherwise experienced limited benefits from SPD.


2020 ◽  
Vol 18 (5) ◽  
pp. 110-116
Author(s):  
С. М. М. СЕХВЕЙЛ ◽  
◽  
З. А. ГОНЧАРОВА ◽  
И. М. БЛИНОВ ◽  
◽  
...  

The purpose is to optimize diagnostics of cervical dystonia using multispiral computed tomography (MSCT) of the cervical spine to improve the results of botulinum toxin therapy. Material and methods. 27 patients diagnosed with the idiopathic CD (21 females among them) were examined. The age of patients ranged from 25 to 72 years old (the average age was 40 (3,3)). All the patients were scanned with 3D multispiral computed tomography (MSCT) of the cervical spine in order to verify the dystonic muscles and determine the degree of head and neck rotation. MSCT helped to identify the cervical spine deformation, the level of its displacement and the state of dystonic muscles. The Tsui et al. rating scale was used for assessing the severity of CD before and after the treatment. Also the intensity of pain syndrome was assessed according to the visual analogue scale (VAS) before and after the treatment. All the patients had injections of botulinum toxin type A, in the dose 200–300 U. The time period between the injections was 3,5–4 months. Results. The study revealed that women tend to have cervical dystonia more often (77,8%). Late diagnostics of the disease still remains. The duration of the disease lasted from 1 month to 18 years. Before the treatment the pain syndrome intensity amounted to 5,6 (0,8) points, according to VAS, whereas after the treatment it was 1,9 (0,8) points. The 3D MSCT revealed the deformation of the cervical spine. MSCT helped to verify the dystonic muscles (a bigger surface of the dystonic muscle in comparison with the healthy part, a more «round» image of the muscle). MSCT of the cervical spine enabled to verify the form of dystonia (caput, collis or their combination). Conclusions. Late diagnostics of CD remains. Botulinum toxin therapy is a highly effective way of CD treatment. The efficiency of the botulinum toxin therapy in the given category of patients depends on the right choice of target muscles, the verification of the form of CD and adherence to the early treatment principle.


PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0245827
Author(s):  
Atul T. Patel ◽  
Mark F. Lew ◽  
Khashayar Dashtipour ◽  
Stuart Isaacson ◽  
Robert A. Hauser ◽  
...  

Cervical dystonia (CD) is primarily treated with botulinum toxin, at intervals of ≥ 12 weeks. We present efficacy, patient-reported outcomes (PROs), and safety in adults with CD at the last available visit after a single set of abobotulinumtoxinA (aboBoNT-A) injections versus placebo using 500 U in a 2-mL injection volume. In this 12-week, randomized, double-blind trial, patients were ≥ 18 years of age with primary idiopathic CD, had a Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥ 20, and TWSTRS-Severity subscale score > 10 at baseline. Patients (N = 134) were randomized (2:1) to aboBoNT-A (n = 89) or placebo (n = 45), with aboBoNT-A patients treated with 500 units (U) if toxin-naïve, and 250 to 500 U based on previous onabotulinumtoxinA dose if non-naïve. Endpoints included total TWSTRS, Pain Numeric Rating Scale (NRS-Pain; 24-hour), Treatment Satisfaction Questionnaire for Medication, and other PROs for pain, depression, and global health. Results are for the intent-to-treat population, with “Week 12” (Wk12) comprising the last available post-baseline assessment (end-of-study or early withdrawal). Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with aboBoNT-A and 42.4 to 40.4 with placebo (treatment difference: –4.8; 95% confidence interval [CI]: –8.5, –1.1; p = 0.011). At Wk12, mean (95% CI) change from baseline in NRS-Pain was –1.0 (–1.59, –0.45) for aboBoNT-A and –0.2 (–0.96, 0.65) for placebo. AboBoNT-A demonstrated numeric improvements in other PROs. More aboBoNT-A–treated patients than patients receiving placebo reported being at least “somewhat satisfied” with treatment (60.4% vs 42.2%, respectively), symptom relief (57.0% vs 40.0%), and time for treatment to work (55.8% vs 33.3%). No new adverse events were reported. Results indicate that in patients with CD, treatment with aboBoNT-A using a 2-mL injection provided sustained improvement in the TWSTRS total score and patient-perceived benefits up to 12 weeks. Trial registration: Clinicaltrials.gov Identified: NCT01753310.


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