Recruiting

Transcutaneous Stimulation

Sponsor:

Martin Piazza

Code:

NCT07516067

Conditions

Cerebral Palsy

Spasticity

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Accepted

Interventions

Transcutaneous Spinal Cord Stimulation (tSCS)

Study Details

Brief summary:

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

Conditions

Cerebral Palsy

Spasticity

Study ID

NCT07516067

Start date

Mar 30, 2026

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

A. Patient-Participant Group (Children with Cerebral Palsy)

  • Children aged 5 to 17 years with a confirmed diagnosis of cerebral palsy.
  • Gross Motor Function Classification System (GMFCS) Levels I to IV, able to walk with or without assistance (walker or cane). This classification will have been completed by Dr. Martin Piazza and his Movement Disorders clinic team.
  • Stable medical condition without recent surgeries or interventions that could affect motor function.
  • Must be able to communicate basic needs and follow simple instructions.
  • Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.

B. Control Group (Children without Neurological Diagnoses)

  • Children aged 5 to 17 years with no history of neurological diagnoses.
  • Must be fully ambulatory without assistance.
  • Must be able to communicate basic needs and follow simple instructions.
  • Provision of informed consent by a parent or legal guardian, with assent from the child as appropriate.

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.
  • Uncontrolled epilepsy or a history of frequent seizures.
  • Severe cognitive impairments limiting the ability to comply with study procedures.
  • Skin conditions or open wounds at the site of stimulation.
  • Participation in other interventional studies that may confound results.
  • Any serious disease or disorder (e.g. cancer, severe cardiac or respiratory disease, etc.) that could affect ability to participate in this study.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control Group

experimental: Cerebral Palsy Group

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.

Interventions

Transcutaneous Spinal Cord Stimulation (tSCS)

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.

Primary outcome measure

  • Change in H-reflex with Transcutaneous Spinal Cord Stimulation [ Time Frame: Measured during 1 of up to 3 research sessions over up to 16 weeks ]
  • Modified Ashworth Scale [ Time Frame: Measured during 1 of up to 3 research sessions over up to 16 weeks ]

Central Contacts and Locations

Central contacts

Bailey McDonald, BS

412-692-9966mcdonaldbm3@upmc.edu

Martin G Piazza, MD

piazzamg@upmc.edu

Locations

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Bailey McDonald, BS

412-692-9966mcdonaldbm3@upmc.edu

Martin G Piazza, MD

piazzamg@upmc.edu

Principal Investigator:

Martin G Piazza, MD

More Information

Sponsor

Martin Piazza

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • Cerebral Palsy
  • Spasticity
  • Spinal Cord Stimulation
  • tSCS
  • TMS
  • Transcutaneous Spinal Cord Stimulation
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Martin Piazza on 2026-04-07.