ClinicalTrials.gg
Enrolling by invitationNCT07930481Updated Nov 12, 2026

Non-invasive Spinal Stimulation for Gait in Genetic Spasticity

An interventional study of Transcutaneous spinal cord stimulation and Sham transcutaneous spinal cord stimulation in Hereditary Spastic Paraplegias, Spinocerebellar Ataxia and Spastic Ataxia, sponsored by University of Washington. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Spastic Paraplegia, Hereditary with a site in United States — 7 open to participants now, 10 under way, none of them phase 3. Spastic Paraplegia, Hereditary · United States.

Started
2026
with 2 others
No phase
3 of 18
2 open now
Registered
18th of 18
by date

Among the 18 studies in Spastic Paraplegia, Hereditary with a site in United States, this one is one of 3 that started in 2026, is one of 3 with no phase, and was the 18th registered.

Spastic Paraplegia, Hereditary

50 studies on the registry are indexed under Spastic Paraplegia, Hereditary; 19 are open to participants now.

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Open to participants now

7 of the 18 studies in Spastic Paraplegia, Hereditary with a site in United States are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 17 Spastic Paraplegia, Hereditary studies recruiting now, 10 (59%) set no upper age limit and 7 (41%) stop at 75 or younger; 13 take children under 18; 3 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

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02

Study summary

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.

Read the detailed description

Potential participants will be screened for study inclusion. Enrollees will undergo baseline testing, including clinical assessments, neurophysiological tests, and questionnaires. Participants will then undergo a four-week block of intensive locomotor training with a physical therapist with either active or sham spinal cord stimulation. During each block, participants will complete three sessions of training with active or sham stimulation per week for four weeks. The assessment battery will be completed at the beginning, midpoint, and end of the block. Participants will then undergo a 4-week "washout" block without stimulation or intensive therapy (although they are welcome to continue outside physical therapy and exercise), followed by another 4-week block with intensive training and either sham or active stimulation. Like the first block, the investigators will complete the battery of assessment measures at the beginning, midpoint, and end of the block. The investigators will also complete follow-up assessments four weeks after the completion of this second block.

The main questions this study hopes to answer are:

  1. Is repetitive tSCS combined with intensive locomotor training feasible and safe to improve gait and mobility in people with hereditary spastic paraplegia?
  2. Does tSCS with intensive locomotor training improve spasticity, strength, and ambulation in patients with HSPs compared to locomotor training alone?
  3. Does the effect of tSCS with locomotor training persist at least four weeks after the conclusion of the training sessions?
  4. What are the most robust and appropriate primary and secondary outcome measures for a larger, multi-center study of tSCS?
03

Conditions studied

  • Hereditary Spastic Paraplegias
  • Spinocerebellar Ataxia
  • Spastic Ataxia

Keywords

  • non-invasive neuromodulation
  • spasticity
  • spinal cord stimulation
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants cannot have severe lower extremity spasticity (Modified Ashworth Scale score of 4).
  2. Participants must not have received botulinum toxin injections in the lower extremities within the previous four months.
  3. Participants may not have joint contractures that limit passive range-of-motion by more than 15 degrees in the lower extremity joints.
  4. Participants may not have an active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump.
  5. Participants must not be actively taking dantrolene for spasticity.
  6. Participants may not have a coexistent neurological condition that may interfere with the results of the study, such as multiple sclerosis, traumatic brain injury, epilepsy, ALS, spinal cord injury, central nervous system vasculitis, intracranial tumor, intracranial aneurysm, or peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy).
  7. Participants may not have active major psychiatric illness that might interfere with treatment, such as severe depression, alcohol and/or drug abuse, or dementia.
  8. Participants may not have any serious medical comorbidities (e.g., cardiac arrhythmia, uncontrolled hypertension, respiratory disease, cancer, renal failure, chronic infectious disease, rheumatic disease) that would prevent participation in study activities.
  9. Participants may not have a history of skin conditions or severe allergy (i.e., allergic reaction that could not be treated with antihistaminic medication) that may affect electrode placement
  10. Participants cannot be pregnant, breastfeeding, or intent to become pregnant during study.

Exclusion criteria

Exclusion Criteria:

  1. Severe lower extremity spasticity (Modified Ashworth Scale score of 4 in the lower extremities).
  2. Botulinum toxin injections in the lower extremities within the previous four months.
  3. Presence of joint contractures of more than 15 degrees in the lower extremity joints.
  4. Presence of an active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump.
  5. Taking dantrolene for spasticity.
  6. Coexistent neurological condition, such as multiple sclerosis, traumatic brain injury, epilepsy, ALS, spinal cord injury, central nervous system vasculitis, intracranial tumor, intracranial aneurysm, or peripheral neuropathy (diabetic polyneuropathy, entrapment neuropathy), etc.
  7. History of major active psychiatric illness that might interfere with treatment, such as severe depression, alcohol and/or drug abuse, or dementia.
  8. History of serious comorbidities (e.g., cardiac arrhythmia, uncontrolled hypertension, respiratory disease, cancer, renal failure, chronic infectious disease, rheumatic disease (RA, SLE), etc.) that would prevent participation in study activities.
  9. History of morphogenic bladder outflow obstruction, such as benign prostatic hyperplasia, urethral stricture, and/or bladder neck contracture.
  10. History of skin conditions or a history of severe allergy (i.e., allergic reaction that could not be treated with antihistamines) that may affect electrode placement.
  11. Pregnancy, breastfeeding, or intent to become pregnant during study.
  12. Participation in another drug, device, or biologic study. concurrently or within 2 months before enrollment.
  13. Lack of ability to fully comprehend, cooperate, comply, and/or safely perform study procedures in the investigator's opinion/judgment.
  14. Unable to read and/or comprehend the consent form.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
4 participants (estimated)

Study arms

  • Sham comparator
    Sham Stimulation

    Participants will undergo intensive locomotor training combined with sham stimulation

    Device: Sham transcutaneous spinal cord stimulation

  • Active comparator
    Active Stimulation

    Participants will undergo active stimulation combined with intensive locomotor training.

    Device: Transcutaneous spinal cord stimulation

Interventions

  • DeviceTranscutaneous spinal cord stimulation

    Participants will undergo intensive locomotor training combined with transcutaneous spinal cord stimulation at T11-L1 level.

  • DeviceSham transcutaneous spinal cord stimulation

    Participants will undergo intensive locomotor training combined with sham transcutaneous spinal cord stimulation at T11-L1 level.

06

What researchers measure

Primary outcomes

  1. Spastic Paraplegia Rating Scale (SPRS)

    This is a 13-point clinical scale that assesses the severity of symptoms attributable to hereditary spastic paraplegia. Scores range from 0 (no impairment) to 52 (severe impairment).

    Time frame: This assessment will be performed at baseline, and again at weeks 2, 4, 8, 10, 12, and 16.

Secondary outcomes

  1. Lower extremity dynamometry

    This is a qantitative assessment of force generated by the muscles of the lower extremity, measured in Newtons.

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  2. 25-foot timed walk test

    This is a quantitative assessment of mobility and leg function that measures the time it takes an individual to safely and quickly walk a distance of 25 feet.

    Time frame: This assessment will be performed at baseline, and again at weeks 2, 4, 8, 10, 12, and 16.

  3. 2-minute walk test

    This is a clinical functional assessment that measures the maximum distance a person can walk on a flat, hard surface in two minutes. Assesses self-paced walking ability, functional endurance, and aerobic capacity.

    Time frame: This assessment will be performed at baseline, and again at weeks 2, 4, 8, 10, 12, and 16.

  4. Hmax/Mmax ratio

    This is an electrophysiological quantification of spasticity.

    Time frame: This assessment will be performed at baseline, and again at weeks 2, 4, 8, 10, 12, and 16.

  5. Mini-Balance Evaluation Systems Test (Mini-BEST)

    This is a clinical assessment of balance performed by a physical therapist. Scores range from 0 (severe balance impairment) to 28 (no balance impairment).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  6. Patient Global Impression of Change (PGIC)

    This is a short, patient-reported outcome measure used in clinical trials and medical practice to evaluate how much a patient's condition has changed since the start of treatment. Scores range from 1 (very much improved) to 7 (very much worsened).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  7. Clinician Global Assessment of Change (CGIC).

    This is a clinician-reported outcome measure used in clinical trials and medical practice to evaluate how much a patient's condition has changed since the start of treatment. Scores range from 1 (very much improved) to 7 (very much worsened).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  8. Neuropathic Bladder Symptom Score (NBSS)

    This is a validated, patient-reported outcome measure, designed to evaluate urinary symptoms, complications, and quality of life in individuals with neurogenic lower urinary tract dysfunction. Scores range from 0 (no symptoms) to 74 (severe symptoms).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  9. Neuropathic Bowel Dysfunction Scale (NBDS)

    This is a 10-item clinical questionnaire used to evaluate bowel symptoms, track treatment effectiveness, and measure quality of life in patients with neurogenic bowel conditions. Scores range from 0 (no symptoms) to 47 (severe symptoms).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  10. Neuropathic Pain Symptom Inventory (NPSI)

    This is a self-administered, 12-item clinical questionnaire designed to evaluate and quantify the specific symptoms of peripheral and central neuropathic pain. Scores range from 0 (no pain) to 100 (worst pain imaginable).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  11. Patient Reported Outcome Measurement Information Systems (PROMIS) Item Bank v1.0 - Pain Interference - Short Form 8a

    This is an 8-point patient-reported questionnaire that measures how much pain hinders a person's physical, mental, emotional, social, and recreational activities over the past 7 days. Scores range from 8 (not at all) to 40 (very much).

    Time frame: This assessment will be performed at baseline, and again at weeks 4, 8, 12, and 16.

  12. Modified Ashworth Scale (MAS)

    This is a clinical assessment used to quantify muscle tone and resistance to passive movement in neurological conditions. Raters will assess spasticity with hip flexion, hip extension, hip adduction, hip internal rotation, hip external rotation, knee flexion, knee extension, and plantarflexion. For each joint tested, scores range form 0 (no spasticity) to 4 (severe spasticity).

    Time frame: This assessment will be performed at baseline, and again at weeks 2, 4, 8, 10, 12, and 16.

07

Study locations

1 site
  • John Wallace Hall, Amplify Movement and Performance Laboratory
    Seattle, Washington 98105, United States
08

References and documents

Publications

  • Tefertiller C, Trumbower RD, Morse L, Pradarelli J, Gelenitis K, D'Amico JM, Moritz C, Field-Fote EC. Home-Based Noninvasive Spinal Cord Stimulation Safely Enhances Hand and Arm Function in People With Spinal Cord Injury. Neurol Clin Pract. 2025 Dec;15(6):e200537. doi: 10.1212/CPJ.0000000000200537. Epub 2025 Sep 24. PubMed 41019097 ↗
  • Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20. PubMed 38769431 ↗
  • Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339. PubMed 29877852 ↗
  • Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2. PubMed 33400652 ↗
  • Hofstoetter US, Freundl B, Danner SM, Krenn MJ, Mayr W, Binder H, Minassian K. Transcutaneous Spinal Cord Stimulation Induces Temporary Attenuation of Spasticity in Individuals with Spinal Cord Injury. J Neurotrauma. 2020 Feb 1;37(3):481-493. doi: 10.1089/neu.2019.6588. Epub 2019 Aug 9. PubMed 31333064 ↗
  • Gelenitis K, Santamaria A, Pradarelli J, Rieger M, Inanici F, Tefertiller C, Field-Fote E, Guest J, Suggitt J, Turner A, D'Amico JM, Moritz C. Non-invasive Transcutaneous Spinal Cord Stimulation Programming Recommendations for the Treatment of Upper Extremity Impairment in Tetraplegia. Neuromodulation. 2025 Jan;28(1):162-173. doi: 10.1016/j.neurom.2024.05.005. Epub 2024 Jul 3. PubMed 38958629 ↗
  • Gad PN, Kreydin E, Zhong H, Latack K, Edgerton VR. Non-invasive Neuromodulation of Spinal Cord Restores Lower Urinary Tract Function After Paralysis. Front Neurosci. 2018 Jun 29;12:432. doi: 10.3389/fnins.2018.00432. eCollection 2018. PubMed 30008661 ↗
  • D'Amico J, Gelenitis K, Inanici F, Field-Fote EC, Tefertiller C, Moritz C. Improved Sensation With Transcutaneous Spinal Cord Stimulation Following Chronic Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2026;34:10-19. doi: 10.1109/TNSRE.2025.3628192. PubMed 41191460 ↗
  • Ardolino G, Bocci T, Nigro M, Vergari M, Di Fonzo A, Bonato S, Cogiamanian F, Cortese F, Cova I, Barbieri S, Priori A. Spinal direct current stimulation (tsDCS) in hereditary spastic paraplegias (HSP): A sham-controlled crossover study. J Spinal Cord Med. 2021 Jan;44(1):46-53. doi: 10.1080/10790268.2018.1543926. Epub 2018 Dec 3. PubMed 30508408 ↗

Individual participant data

Plan to share: No — We do not currently have plans to share individual patient data with other researchers. Data may be available upon request as appropriate.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Jun 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 29, 2026
First posted
Nov 12, 2026
StartEst.
Nov 2026
Primary completionEst.
Jun 2027
CompletionEst.
Nov 2027
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07930481
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS), Rare Diseases Clinical Research Network (RDCRN)
Responsible party
John Sanderson (Fellow: School of Medicine, Neurology, University of Washington) — Principal investigator
First posted
Nov 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Nov 12, 2026

Study contacts

John B Sanderson, MD
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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