Recruiting

Dorsal Root Stimulation

Sponsor:

Martin Piazza

Code:

NCT07715006

Conditions

Cerebral Palsy (CP)

Cerebral Palsy

Spasticity

Spasticity Due to Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 3 - 14

Healthy Volunteers: Not accepted

Interventions

Constant Current Stimulator

Cadwell Guardian System

Study Details

Brief summary:

The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).

Conditions

Cerebral Palsy (CP)

Cerebral Palsy

Spasticity

Spasticity Due to Cerebral Palsy

Study ID

NCT07715006

Start date

Jul 16, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 14

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children ages 3 to 14
  • Diagnosis of Cerebral Palsy
  • Require an SDR as determined by the multidisciplinary movement disorders team
  • Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.

Exclusion Criteria:

  • No exclusion criteria

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cerebral Palsy Group

The investigators will use the DS8R to directly deliver electrical stimulation with hook electrodes to the dorsal roots while testing the spasticity of individual dorsal roots.

Interventions

Constant Current Stimulator

The DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters.

Cadwell Guardian System

The Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.

Primary outcome measure

  • Peak-to-peak amplitude of the dorsal root reflex [ Time Frame: In session during the surgery (1 session) ]

Central Contacts and Locations

Central contacts

Bailey McDonald, BS

412-692-9966mcdonaldbm3@upmc.edu

Martin G Piazza, MD

piazzamg@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Bailey G McDonald, BS

412-692-9966mcdonaldbm3@upmc.edu

Martin G Piazza, MD

piazzamg@upmc.edu

Principal Investigator:

Martin G Piazza, MD

More Information

Sponsor

Martin Piazza

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • Dorsal root electrical stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Martin Piazza on 2026-08-11.