Recruiting

ITB & CR

Sponsor:

Boston Children's Hospital

Code:

NCT07817745

Conditions

Spastic/Dystonic Quadriplegia

Cerebral Palsy (CP)

Eligibility Criteria

Sex: All

Age: 6 - 25

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Spastic/Dystonic Quadriplegia

Cerebral Palsy (CP)

Study ID

NCT07817745

Start date

Jun 26, 2024

Status verified date

Aug, 2026

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 25

Healthy Volunteers: Not accepted

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:

\-

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Adam Porter, Research Manager, MPH

617-919-6013adam.porter@childrens.harvard.edu

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Principal Investigator:

Weston Northam, MD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Sep 14, 2026

Last verified

Aug, 2026

Keywords

  • CP
  • Cerebral Palsy
  • Tone Management
  • Dystonic
  • Spastic
  • Spasticity
  • Intrathecal Baclofen Pump
  • Combined Dorsal/Ventral Rhizotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-09-14.