Home › Muscle Spasticity › NCT07817745

Outcomes of Neurosurgical Tone Management

Who can join

Ages 6 to 25 · All sexes

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:

\-

About the study

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.

Sponsor: Boston Children's Hospital · Participants: 100 · Started: Jun 26, 2024

Contact the study team

• Adam Porter, Research Manager, MPH · Phone: 617-919-6013

Official record on ClinicalTrials.gov — NCT07817745

Locations in the U.S.

Conditions

• Muscle Spasticity
• Cerebral Palsy

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.