Dorsal Root Electrical Stimulation in Children With Cerebral Palsy

NCT07715006 | Recruiting FDA Device

• 1 other identifier: STUDY26040193
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

Dorsal root electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Peak-to-peak amplitude of the dorsal root reflex

  The investigators will assess whether dorsal root electrical stimulation at frequencies (40-5000Hz) can normalize the abnormally large muscle response to electrical stimulation of the same dorsal root at low frequencies that is a signature of spasticity in CP. The investigators will measure the peak-to-peak amplitude of the dorsal root reflex with intramuscular EMGs. Succes criteria: A 20% reduction in the peak-to-peak amplitude of the spinal reflex

  In session during the surgery (1 session)

Study Arms (1)

Cerebral Palsy Group

EXPERIMENTAL

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.

Device: Constant Current Stimulator; Device: Cadwell Guardian System

Interventions

Constant Current Stimulator DEVICE

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

Cerebral Palsy Group

Cadwell Guardian System DEVICE

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

Cerebral Palsy Group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• Martin Piazza: lead

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin G Piazza, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bailey McDonald, BS

CONTACT

412-692-9966; mcdonaldbm3@upmc.edu

Martin G Piazza, MD

CONTACT

piazzamg@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Pediatric Neurosurgery

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 20, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)