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NCT Number: NCT07715006

Dorsal Root Electrical Stimulation in Children With Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity Spasticity Due to Cerebral Palsy

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location status: Recruiting

Location contact

Bailey G McDonald, BS

CONTACT

[email protected]

412-692-9966

Genis Prat-Ortega, PhD

SUB_INVESTIGATOR

Jeffrey Balzer, PhD

SUB_INVESTIGATOR

Martin G Piazza, MD

CONTACT

[email protected]

Martin G Piazza, MD

PRINCIPAL_INVESTIGATOR

Taylor Abel, MD

SUB_INVESTIGATOR

About this study

The investigators will recruit participants with CP requiring selective dorsal rhizotomy (SDR) surgery. During SDR, spastic dorsal roots are routinely identified by electrically stimulating each root at low frequency (1 Hz) and measuring the resulting muscle response via electromyography - a procedure called "clinical test stimulation." Dorsal roots that produce an abnormally large and widespread compound muscle action potential (CMAP) are classified as spastic. In this study, the investigators will superimpose higher-frequency dorsal root stimulation (40-5000 Hz) on top of this standard clinical test stimulation and assess whether it suppresses the abnormal large CMAP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Cadwell Guardian System

Device

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

Primary outcomes

  1. Peak-to-peak amplitude of the dorsal root reflex

    Time frame: In session during the surgery (1 session)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Bailey McDonald, BS

CONTACT

[email protected]

412-692-9966

Martin G Piazza, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Martin Piazza

Other

Registry information

Official study title

Dorsal Root Electrical Stimulation to Suppress Spastic Muscle Activation in Children With Cerebral Palsy

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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