Outcomes of Neurosurgical Tone Management

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT07817745
Status
Recruiting
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Conditions

  • Cerebral Palsy (CP)
  • Spastic/Dystonic Quadriplegia

Eligibility Criteria

Sex
ALL
Age
6 Years - 25 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Sep 14, 2026
Start date
Jun 26, 2024
Status verified
Aug 2026
Primary completion
Jul 1, 2030
Completion
Jan 1, 2031

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Improved Spasticity Score [ Time Frame: From enrollment to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Adam Porter, MPH
[email protected]
617-919-6013
Weston Northam, MD (PRINCIPAL_INVESTIGATOR)
Kristin Buxton, PNP (SUB_INVESTIGATOR)
Juliani Mariani, MD (SUB_INVESTIGATOR)
Scellig Stone, MD, PhD (SUB_INVESTIGATOR)
Carley Vuillermin, MBBS, MPH, FRACS (SUB_INVESTIGATOR)

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