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Purpose

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

Conditions

Eligibility

Eligible Ages
Between 3 Years and 14 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Constant Current Stimulator
    The DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters.
  • Device: Cadwell Guardian System
    The Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.

Recruiting Locations

UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania 15224
Contact:
Bailey G McDonald, BS
412-692-9966
mcdonaldbm3@upmc.edu

More Details

Status
Recruiting
Sponsor
Martin Piazza

Study Contact

Bailey McDonald, BS
412-692-9966
mcdonaldbm3@upmc.edu

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.