An observational study in Spastic/Dystonic Quadriplegia and Cerebral Palsy (CP), sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 6 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Boston Children's Hospital · Observational
Patients with spastic/dystonic quadriplegia (GMFCS IV/V) are often severely disabled by their tone, and require surgical tone management to improve quality of life, allow for better function, improve comfort, and range of motion. This has historically been limited to Intrathecal Baclofen (ITB) pumps, which are effective for up to 85% of patients but carry significant morbidity / complications and are not appropriate for many patients. More recently, combined dorsal/ventral rhizotomy (CR) has emerged as an alternative means for tone control, a one-time surgery with no required hardware implantation. However, more information is needed regarding long-term outcomes of this procedure in addition to comparative outcomes of ITB. This information will lead to improved patient selection, counseling, and care. This is a prospectively enrolled, single-center study, involving survey administration and clinical observation of outcomes pre- and post-surgery.
621 studies on the registry are indexed under Muscle Spasticity; 127 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 137 observational studies indexed under Muscle Spasticity.
Browse Muscle Spasticity studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will be recruited from the Cerebral Palsy and multidisciplinary tone management clinic.
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Exclusion Criteria:
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Improved Spasticity Score
We will study changes in Spasticity using the Modified Ashworth Scale in participants over the course of this study.
Time frame: From enrollment to 5 years
Improved Dystonia Score
We will use the Barry Albright Dystonia Scale to measure changes in dystonia in participants over the course of this study.
Time frame: From enrollment to 5 years.
Overall Quality of Life Improvements
We will use the CP-Child survey to measure quality of life changes in participants over the course of this study. Specifically looking at trends in caregiver satisfaction with hygiene, and comfort.
Time frame: From enrollment to 5 years
Reduced Surgical Complications
We will review outcomes for our participants to quantify surgical complications such as infection, malfunction, re-operation, spinal fluid leak, prolonged urinary retention, muscle wasting, and decubitus ulcer formation.
Time frame: From enrollment to 5 years.
Plan to share: Undecided — The study is currently undecided about IPD sharing due to IRB and participant confidentiality considerations, entity-level legal requirements, and the ongoing status of the study.
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