Botulinum Toxins

Children and their families were invited to participate in this study while attending their regular clinic appointment at the Spasticity Management Clinic at McMaster Children’s Hospital. Both parents were invited to participate in the interview. Assessment in clinic was conducted as usual, but there was a more thorough discussion on setting goals related to BoNT-A treatment. The interviews took place after the assessment by the therapist, but before a decision was made with the physician. After a decision was made and BoNT-A treatment was recommended, it was administrated either in clinic or under sedation at a different time.
For the purpose of this study, the interview was conducted with parents during the clinical appointment. Initially parents were asked an open-ended question of: “What kinds of goals do you have for your child with cerebral palsy after receiving botulinum toxin treatment?” Following the discussion, parents were provided with a draft of the inventory of goals developed by SIG (see Additional file 1, PDF document: Inventory of Goals in the Context of Botulinum Toxin A Treatment). Parents were asked to identify and select the goals listed in the inventory that they find are most important or meaningful to achieve following the BoNT-A treatment. After completing the inventory of goals, parents were asked to provide additional goals that they had considered and were missing from the inventory. The family, child, and multidisciplinary team also had a discussion about the process of setting goals when the child was being assessed for BoNT-A treatment. The goals discussed and selected by the family and the spasticity team members were recorded by the student research assistant who was observing the discussion.
Treatments goals were categorized according to the domains of body function/structure, activity, and participation in the International Classification of Functioning, Disability, and Health (ICF) [7 (link)]. The categorization of the goals into the ICF domains was based on a discussion between the research assistant and healthcare professionals in the Spasticity Clinic at McMaster Children’s Hospital.

Ten healthy, right-handed females (mean age = 36.4; range = 33–40 years old) with no history of using botulinum toxin participated in the study. We restricted enrollment to only females because emotional responsivity varies for males and females^{23 (link)–25 (link)} and we wanted to reduce variability given our small sample size. Prior to enrollment, participants were screened and excluded for the presence of neurological or psychiatric conditions and the presence of any risk factors for MRI. Participants were recruited from the University of California at Irvine (UCI) and the surrounding community via e-mail blasts, flyers, social media, and word-of-mouth. They provided written consent in compliance with the UCI Institutional Review Board and received $100 compensation for 2 MRI scans and free cosmetic onabotA injections. This study was approved by the UCI Institutional Review Board and was conducted in accordance with the Declaration of Helsinki.

Pediatric patients with predominantly spastic CP were recruited as a convenience sample. Inclusion criteria were CCP from all GMFCS levels and between 2 and 18 years of age. They were either botulinum toxin naïve or had a latency period of 6 months from the last injection and had at least moderate pain when evaluated by the revised face, legs activity, cry, consolability scale (r-FLACC ≥ 4) during passive range of motion (pROM). The pain response determined the candidate muscles for injection with BoNT. Subjects were excluded if they had fixed contracture or severe athetoid/dystonic afflictions, or if modifications in their ongoing treatment that would affect the pain status had either taken place 3 months before the BoNT injection or during the evaluation period (antispastic or pain medication given orally or by injection or if subjects had interfering surgical procedures performed).