Spinal Cord Stimulation for Cerebral Palsy

Overseen By Martin G Piazza, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Martin Piazza

Disqualifiers: Implanted devices, Severe scoliosis, Epilepsy, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Up to 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children. The main questions it aims to answer are:

* What are the mechanisms of spinal circuit hyperexcitability in CP?

* Can transcutaneous spinal cord stimulation reduce spinal circuit hyperexcitability?

Participants with cerebral palsy will be asked to complete:

* Movement and strength exercises

* Mild, non-invasive stimulation on the back and legs that feels like a light tap.

* Gentle, non-invasive tests that help us see how the brain and the spinal cord communicate with the muscles

Who Is on the Research Team?

Martin G Piazza, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 5-17 years old, have no neurological issues, can walk and communicate on my own.

I am 5-17 years old with cerebral palsy, can walk, and have a stable condition.

Exclusion Criteria

Presence of implanted medical devices (e.g., baclofen pumps, deep brain stimulators) that may interfere with TSCS

Severe scoliosis or spinal deformities that could affect the delivery of tSCS

I have uncontrolled epilepsy or often experience seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Electrophysiological and clinical assessments conducted to evaluate spinal excitability and spasticity

1 session

1 visit (in-person)

Treatment

Transcutaneous spinal cord stimulation (tSCS) administered to assess impact on spinal excitability and spasticity

Up to 16 weeks

Up to 3 visits (in-person)

Follow-up

Participants are monitored for changes in spinal excitability and spasticity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Spinal Cord Stimulation (tSCS)

How Is the Trial Designed?

Group I: Cerebral Palsy Group Experimental Treatment 1 Intervention

Transcutaneous spinal cord stimulation (tSCS) will be administered using the Digitimer DS8R Biphasic Constant Current Stimulator, an external isolated stimulator system used in human research. The DS8R delivers controlled electrical pulses with adjustable stimulation parameters. tSCS will be delivered at frequencies between 30-50 Hz with 1 ms pulse width and a biphasic waveform. Self-adhesive surface electrodes will be positioned longitudinally over the thoracolumbar region at T11-L1 (cathodes) and over the iliac crests (anodes). In children with cerebral palsy, electrophysiological and clinical assessments will be conducted before, during, and after stimulation to evaluate changes in spinal excitability, spasticity, and motor function. Stimulation is administered during supervised study visits.

Group II: Control Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

Martin Piazza

Lead Sponsor