Cerebral Palsy, Cerebral Palsy (CP), Spasticity, Spasticity Due to Cerebral Palsy
Conditions
Keywords
Dorsal root electrical stimulation
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).
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.
Interventions
DEVICEConstant Current Stimulator
The DS8R is an external isolated stimulator system used in human research (DS8R), delivers controlled electrical pulses with adjustable stimulation parameters.
DEVICECadwell Guardian System
The Cadwell Guardian System is a clinical intraoperative system used to deliver stimulation in the dorsal root during SDR.
Sponsors
Martin Piazza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak-to-peak amplitude of the dorsal root reflex | 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 |
Countries
United States
Contacts
CONTACTBailey McDonald, BS
CONTACTMartin G Piazza, MD
PRINCIPAL_INVESTIGATORMartin G Piazza, MD
University of Pittsburgh
Outcome results
None listed