30 Participants NeededMy employer runs this trial

Spinal Cord Stimulation for Cerebral Palsy

BM
MG
Overseen ByMartin G Piazza, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how spinal cord stimulation might help children with cerebral palsy by reducing issues with their spinal circuits' reactions. The study involves gentle exercises and a non-invasive procedure called Transcutaneous Spinal Cord Stimulation (tSCS), which feels like a light tap, to determine if it improves muscle control and communication between the brain and spinal cord. It seeks children with cerebral palsy who can walk, with or without assistance, and follow simple instructions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for cerebral palsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an implanted medical device or uncontrolled epilepsy, you may not be eligible to participate.

What prior data suggests that transcutaneous spinal cord stimulation is safe for children with cerebral palsy?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe for people. In past studies, participants, including children with cerebral palsy, have tolerated tSCS well. For instance, one study reported no severe side effects during or after the sessions. Another study found that children managed the treatment well at various intensity levels, indicating it can be tailored to individual needs.

Moreover, a meta-analysis, which combines results from several studies, confirmed the safety of tSCS. Participants did not report any major negative effects, suggesting that the treatment is quite safe. These findings provide reassurance about trying tSCS, as it appears to be a safe option for managing symptoms in cerebral palsy.12345

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral palsy, which typically include physical therapy, medication, and sometimes surgery, Transcutaneous Spinal Cord Stimulation (tSCS) offers a non-invasive approach. Researchers are excited about tSCS because it directly stimulates the spinal cord using electrical pulses, potentially enhancing motor function and reducing spasticity without the need for invasive procedures. This technique uses external electrodes placed on the skin, making it a less intrusive option that could provide immediate benefits during supervised sessions. By targeting spinal excitability directly, tSCS offers a novel mechanism that could complement or even improve upon existing therapies.

What evidence suggests that transcutaneous spinal cord stimulation might be an effective treatment for cerebral palsy?

Research has shown that transcutaneous spinal cord stimulation (tSCS) may improve movement in children with cerebral palsy. In this trial, the Cerebral Palsy Group will receive tSCS to evaluate its effects on muscle control, stiffness, and spasms, which are common in cerebral palsy. Studies have found that tSCS can help with these issues, and some children and their parents have noticed better walking coordination and less fatigue after tSCS treatments. When combined with other therapies, tSCS has led to improvements in strength and walking ability. These findings suggest that tSCS could be a helpful treatment for children with cerebral palsy by possibly enhancing their mobility and daily activities.12346

Who Is on the Research Team?

MG

Martin G Piazza, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children aged 5 to 17. One group includes kids with cerebral palsy who can walk (with or without help) and have stable health. The other group is healthy children with no neurological issues, able to walk unaided. Kids must be able to follow simple instructions and not have certain medical devices, severe spine problems, uncontrolled seizures, or serious illnesses.

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.
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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)

Trial Overview

The study tests a gentle, non-invasive spinal cord stimulation (tSCS) applied through the skin on the back and legs in children with cerebral palsy compared to healthy peers. It aims to see if tSCS can reduce muscle stiffness by affecting how nerves communicate between the brain and muscles.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cerebral Palsy GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Martin Piazza

Lead Sponsor

Citations

Transcutaneous Spinal Stimulation Combined with Locomotor ...

This case study highlights the potential of TSS to augment neuroplasticity-driven treatment approaches, leading to improvements in neuromotor function in ...

Spinal Cord Stimulation for Children With Cerebral Palsy

The goal of this clinical trial is to help understand spinal cord excitability in children with cerebral palsy compared to neurologically typical children.

Effectiveness of Transcutaneous Spinal Cord Stimulation for ...

The primary outcome will be lower limb motor function assessed by validated measures such as the Lower Extremity Motor Score. Secondary outcomes ...

Transcutaneous Spinal Cord Stimulation Improves ...

Conclusions: tSCS+SBLTT reduced spasticity in LE muscles more than SBLTT alone for children with CP. Both parent and child's perception of their ADLs and ...

Transcutaneous Spinal Stimulation and Short-burst Interval ...

Children and parents reported reduction in fatigue, and improved self-reported gait outcomes after tSCS + SBLTT. Improvements in spasticity and ...

Safety and Effectiveness of Multisite Transcutaneous ...

Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...