Dorsal Root Electrical Stimulation for Spasticity in Children with Cerebral Palsy
This study is looking at whether a special type of electrical stimulation, called dorsal root electrical stimulation, can help reduce spasticity (muscle stiffness) in children with cerebral palsy (CP). Researchers will use two devices, the DS8R and the Cadwell Guardian System, to deliver controlled electrical pulses to the dorsal roots during a surgery called selective dorsal rhizotomy (SDR). This surgery is already a standard treatment for some children with CP. The study will measure how much the electrical stimulation changes the muscle response during the surgery. Children aged 3 to 14 with a diagnosis of CP who are already scheduled for SDR surgery are eligible to participate. The study is currently unclear on its recruitment status and plans to enroll 15 participants.
- Study design
- This interventional study plans to enroll 15 participants. It is not specified if it is randomized, blinded, or what phase it is in.
- What's involved
- Participants will undergo dorsal root electrical stimulation during their scheduled selective dorsal rhizotomy (SDR) surgery. The primary measurement will occur during this single surgical session.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured during the surgery session, so long-term follow-up is not specified beyond this.
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Dorsal Root Electrical Stimulation in Children With Cerebral Palsy
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Martin G Piazza, MD · PRINCIPAL_INVESTIGATOR · University of Pittsburgh
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Peak-to-peak amplitude of the dorsal root reflexIn 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