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Spinal Stimulation for Hereditary Spastic Paraplegia

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Washington
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 is a double-blind, crossover, sham-controlled pilot study to evaluate the feasibility, safety, and preliminary efficacy of repeated transcutaneous spinal cord stimulation (tSCS) over the lower thoracic and upper lumbar spinal segments in adults with hereditary spastic paraplegias (HSPs) and other genetic causes of spasticity. The investigators will recruit four people with hereditary lower extremity spasticity who are able to ambulate with or without assistive devices to participate in the trial. The investigators will assess a range of outcome measures to evaluate tSCS in this patient population and to inform the design of a larger study.

Who Is on the Research Team?

JB

John B Sanderson, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults with hereditary spastic paraplegia or similar genetic conditions causing leg stiffness and difficulty walking. Participants must be able to walk, even if they need a cane or walker.

Inclusion Criteria

Participants may not have an active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
Participants may not have active major psychiatric illness that might interfere with treatment, such as severe depression, alcohol and/or drug abuse, or dementia
Participants cannot be pregnant, breastfeeding, or intent to become pregnant during study
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Exclusion Criteria

I have had botox injections in my legs in the last four months.
History of major active psychiatric illness that might interfere with treatment, such as severe depression, alcohol and/or drug abuse, or dementia
History of serious comorbidities (e.g., cardiac arrhythmia, uncontrolled hypertension, respiratory disease, cancer, renal failure, chronic infectious disease, rheumatic disease (RA, SLE)) that would prevent participation in study activities
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What Are the Treatments Tested in This Trial?

Interventions

  • Transcutaneous Spinal Cord Stimulation

Trial Overview

The study tests non-invasive electrical stimulation of the spinal cord (tSCS) compared to a sham (inactive) version. Each participant receives both treatments in random order, and neither participants nor researchers know which is given at any time.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Active StimulationActive Control1 Intervention
Group II: Sham StimulationPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Rare Diseases Clinical Research Network (RDCRN)

Collaborator

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