Dorsal Root Electrical Stimulation in Children With Cerebral Palsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorMartin Piazza
About this trial
The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
No exclusion criteria
Trial design
Design model
Single group
Treatments tested in this trial
Constant Current Stimulator
DeviceThe DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters.
Cadwell Guardian System
DeviceThe Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Cerebral Palsy GroupExperimental treatment 2 interventions
Trial outcomes
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
Time frame
In session during the surgery (1 session)Sponsors and contacts
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Martin Piazza
Lead sponsor
University of Pittsburgh
Sponsor institution
Source ClinicalTrials.gov