Spinal Cord Stimulation for Spastic Paraplegia

Overseen By Rahul Sachdeva, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rahul Sachdeva

Must be taking: Spasticity medications

Must not be taking: Botulinum toxin

Disqualifiers: Pacemaker, Cardiopulmonary disease, Pregnancy, Epilepsy, others

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

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Hereditary spastic paraplegia (HSP) is a rare neurological condition that causes stiffness, weakness, and difficulty walking due to damage in the nerves that control movement. This study will test whether a noninvasive form of spinal cord stimulation, called transcutaneous spinal cord stimulation (tSCS), can improve walking and reduce muscle stiffness in adults with HSP.

In this study, participants will receive tSCS twice a week for 8 weeks. The stimulation is delivered through self-adhesive electrodes placed on the skin over the lower back and does not require surgery. Each session will last about one hour. After the treatment period, participants will be followed for an additional 8 weeks without stimulation to see whether any improvements are maintained. Researchers will measure walking speed, walking endurance, muscle stiffness, and overall disease severity. Additional tests will explore changes in bladder and bowel function and muscle strength.

Who Is on the Research Team?

Rahul Sachdeva, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

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)

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

How Is the Trial Designed?

Group I: Participants with Hereditary Spastic Paraplegia Experimental Treatment 1 Intervention

Participants will undergo 16 transcutaneous spinal cord stimulation (tSCS) sessions over 8 weeks

Who Is Running the Clinical Trial?

Rahul Sachdeva

Lead Sponsor

Spastic Paraplegia Foundation

Collaborator