Outcomes of tone-management surgery in children with spastic/dystonic quadriplegia
Official title: Outcomes of Neurosurgical Tone Management
Run by Boston Children's Hospital · NCT07817745 · Data updated 2026-11-12
This study tests how well intrathecal baclofen pumps and dorsal/ventral rhizotomy help improve movement, comfort, and daily life for kids with severe CP and high muscle tone.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 25 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | June 26, 2024 |
| Main results expected | July 1, 2030 |
| Study ends | January 1, 2031 |
| Registry record updated | September 14, 2026 |
| Trial ID | NCT07817745 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 6 years or older with spastic or dystonic quadriplegia (GMFCS IV/V) undergoing intrathecal baclofen pump placement or combined dorsal/ventral rhizotomy at Boston Children's Hospital.
✕Probably not a fit
Patients who do not experience improvement in tone or function after surgery or those for whom neither procedure is suitable may see little or no benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study at Boston Children's Hospital evaluating outcomes before and after tone-management procedures in children and young people with spastic or dystonic quadriplegia (GMFCS IV/V). Participants undergo either intrathecal baclofen pump insertion or combined dorsal/ventral rhizotomy, with surveys and clinical observations tracking changes in function, comfort, and quality of life over time. The goal is to improve patient selection and counseling by comparing long-term outcomes of these approaches. Data will be collected from patients aged 6 years and older undergoing the procedures at the institution. Results may inform future care strategies for severe tone management in CP.
Why it matters
Potential benefit: If successful, the study could clarify which tone-management approach offers better long-term outcomes and quality of life for children with severe CP.
How similar studies have gone: Prior experience with intrathecal baclofen and rhizotomy suggests potential benefit, but long-term comparative data remain limited, making this study exploratory.
Who can join: the full rules
Show full inclusion / exclusion 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: \-
Where it's running
-
Boston Children's Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Weston Northam, MD — Boston Children's Hospital
- Study coordinator: Adam Porter, Research Manager, MPH
- Email: adam.porter@childrens.harvard.edu
- Phone: 617-919-6013
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Manual Therapy Before Neuromotor Rehab in Children with Cerebral Palsy
In this pilot study, researchers test whether 30 minutes of lower-limb manual therapy before functional neuromotor therapy helps improve gait and motor performance in children with spastic cerebral palsy.
-
Co-designed wrist-hand orthosis for children with neuromotor disorders
In children aged 6 to 14 with neuromotor conditions after brain injury, researchers are testing a wrist-hand brace designed with input from the kids to see if it fits better and is easier to use than their current orthosis.
-
Wearable eye tracking during bimanual tasks in children with cerebral palsy
This study tests whether wearable eye-tracking glasses can reliably record eye movements while children with CP and typically developing peers perform two-handed tasks.
-
Able Kids device: safer gait aid for kids with neurologic gait problems
This study tests whether the ABLE Kids wearable exoskeleton can be safely used during a 10-session gait training program for children with neurological gait disorders or muscle weakness.
-
Dorsal Root Electrical Stimulation to Help Spasticity in Children with Cerebral Palsy
This study tests whether adding dorsal root electrical stimulation during SDR surgery can lessen spasticity in children with cerebral palsy.
-
Effects of motor imagery and action observation on motor function in unilateral cerebral palsy
In children with unilateral cerebral palsy, this study tests whether adding motor imagery and action observation therapy to standard physical therapy can improve hand and arm function and quality of life.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.