15 Participants NeededMy employer runs this trial

Spinal Cord Stimulation for Spastic Paraplegia

RS
Overseen ByRahul Sachdeva, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rahul Sachdeva
Must be taking: Spasticity medications
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 tests whether transcutaneous spinal cord stimulation (tSCS), a noninvasive treatment, can benefit individuals with hereditary spastic paraplegia, a condition causing muscle stiffness and walking difficulties. Participants will undergo this treatment twice a week for eight weeks using sticky pads placed on their lower back, avoiding any surgery. Researchers aim to determine if the treatment improves walking and reduces muscle stiffness, monitoring these changes for an additional eight weeks after the sessions conclude. Individuals with hereditary spastic paraplegia, stable on their medications for at least four weeks, and capable of walking or performing mobility tasks with or without assistive devices might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore a promising treatment option that could enhance mobility and quality of life.

Will I have to stop taking my current medications?

The trial requires that your medications for spasticity and other neurological symptoms be stable for at least 4 weeks before joining. You should not expect to start or change these treatments during the study.

What prior data suggests that this spinal cord stimulation is safe for hereditary spastic paraplegia?

Research has shown that transcutaneous spinal cord stimulation (tSCS) is generally safe and well-tolerated. In studies involving individuals with spinal cord injuries, participants found the treatment manageable and safe. These studies reported no serious side effects.

Participants did not encounter major problems or complications during or after the treatment. Some individuals might experience mild discomfort at the electrode sites, but this is typically not a significant concern.

Overall, evidence suggests that tSCS is a safe option for those considering clinical trials for conditions like hereditary spastic paraplegia.12345

Why are researchers excited about this trial?

Transcutaneous spinal cord stimulation (tSCS) is unique because it offers a non-invasive way to manage spastic paraplegia, unlike current treatments that often involve oral medications or invasive procedures. This method stimulates the spinal cord externally, potentially reducing muscle stiffness and improving mobility without the need for surgery. Researchers are excited about tSCS because it targets the spinal cord directly, which could lead to faster and more precise relief of symptoms compared to traditional systemic drug therapies.

What evidence suggests that transcutaneous spinal cord stimulation might be an effective treatment for hereditary spastic paraplegia?

Research has shown that transcutaneous spinal cord stimulation (tSCS) might help individuals with hereditary spastic paraplegia (HSP) walk better and feel less stiff. In this trial, participants with HSP will undergo 16 tSCS sessions over 8 weeks. Studies have found that tSCS can enhance leg movement and increase walking speed. Participants in earlier studies reported reduced muscle stiffness, with some experiencing up to a 100% improvement. tSCS has also helped with spasticity, a common symptom of HSP. Although the exact mechanism remains unclear, these findings suggest that tSCS could be promising for those with HSP symptoms.16789

Who Is on the Research Team?

RS

Rahul Sachdeva, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for adults with hereditary spastic paraplegia who can walk at least 10 meters (with or without aids) or perform seated mobility tasks. Participants must have stable medications, be able to follow instructions in English, and not have other major neurological conditions, implanted devices, pregnancy, severe heart/lung disease, open skin issues at electrode sites, or recent medication changes.

Inclusion Criteria

I have been diagnosed with hereditary spastic paraplegia.
My medications for spasticity and neurologic symptoms have not changed for 4 weeks.
I am able to attend study visits and assessments, even if I need assistive devices.
See 3 more

Exclusion Criteria

I cannot complete movement tests, even with my usual mobility aid.
I have PLS or another neurological condition that affects my ability to walk.
Implanted electronic devices (e.g., pacemaker, deep brain stimulator, intrathecal pumps)
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous spinal cord stimulation (tSCS) twice a week for 8 weeks

8 weeks
16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment without stimulation

8 weeks
4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • transcutaneous spinal cord stimulation

Trial Overview

The study tests noninvasive spinal cord stimulation (tSCS), delivered through electrodes on the lower back twice a week for 8 weeks. The goal is to see if tSCS improves walking and reduces muscle stiffness in people with HSP. After treatment ends, participants are monitored for another 8 weeks to check if benefits last.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with Hereditary Spastic ParaplegiaExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rahul Sachdeva

Lead Sponsor

Spastic Paraplegia Foundation

Collaborator

Citations

Spinal direct current stimulation (tsDCS) in hereditary spastic ...

The results are in line with previous data on spinal cord injuries and chronic stroke, thereby confirming the efficacy of tsDCS for the treatment of spasticity.

Effectiveness of transcutaneous spinal cord stimulation for ...

The main findings indicate that tSCS may improve lower limb motor function and walking speed, with the highest quality evidence from Comino-Suárez et al. [38] ...

Transcutaneous Spinal Cord Stimulation for Spasticity in...

All participants showed a reduction in MAS sum scores ranging from 100% reduction (participant 4) to 14.3% reduction (participant 1). Three of 6 ...

Controversies and Clinical Applications of Non-Invasive ...

Despite unclear mechanisms of action, clinical benefits of TsMS have been reported, including improvements in scales of spasticity, hyperreflexia, and bladder ...

NCT07375745 | Spinal Stimulation With Gait Training to ...

Recent findings suggest that adding transcutaneous spinal cord stimulation (tSCS) to ABT in chronic SCI (> 12 months) can enhance lower-limb motor recovery.

Patient-reported effects of transcutaneous spinal cord ... - PMC

The review concluded that tSCS appears to be safe and well-tolerated in individuals with spinal cord injury (SCI), but the evidence regarding ...

Safety and Effectiveness of Multisite Transcutaneous ...

This clinical trial (Pathfinder 2.0, NCT04132596) assessed the safety and effectiveness of tSCS combined with ABT (tSCS-ABT) when delivered in a community-based ...

Spinal Cord Stimulation Therapy for Hereditary Spastic ...

It's a single-center, prospective, open label clinical study with a 12 months follow-up period, to investigate the therapeutic effect and safety of spinal ...

Effectiveness of transcutaneous spinal cord stimulation for ...

Primary outcomes were lower limb motor function and walking ability, while secondary outcomes included spasticity, functional independence, ...