Outcomes of Neurosurgical Tone Management
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-25
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Any patients undergoing intrathecal baclofen pump insertion or combined dorsal ventral rhizotomy at Boston Children's Hospital.
Must be at least 6 years of age at time of enrollment
Disqualifiers
None
Trial population
Patients will be recruited from the Cerebral Palsy and multidisciplinary tone management clinic.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 years2
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.Secondary outcomes
1
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 years2
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.Sponsors and contacts
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Source ClinicalTrials.gov