NCT07817745 Outcomes of Neurosurgical Tone Management
| NCT ID | NCT07817745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Spastic/Dystonic Quadriplegia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-06-26 |
| Primary Completion | 2030-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-06-26 with a primary completion date of 2030-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: \-
Contact & Investigator
Weston Northam, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT07817745 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 25 Years, studying Spastic/Dystonic Quadriplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07817745 currently recruiting?
Yes, NCT07817745 is actively recruiting participants. Contact the research team at adam.porter@childrens.harvard.edu for enrollment information.
Where is the NCT07817745 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07817745 clinical trial?
NCT07817745 is sponsored by Boston Children's Hospital. The principal investigator is Weston Northam, MD at Boston Children's Hospital. The trial plans to enroll 100 participants.