Who is sponsoring NCT05095454?

NCT05095454 is sponsored by Kristin Zhao, PhD.

What drugs are being tested in NCT05095454?

Interventions in NCT05095454: Percutaneous epidural electrical spinal stimulation, Transcutaneous electrical spinal stimulation.

What condition does NCT05095454 study?

NCT05095454 studies Paraplegia, Tetraplegia, Paralysis, Quadraplegia.

Is NCT05095454 still recruiting?

NCT05095454 is currently completed. Last updated 9 July 2024.

Are results published for NCT05095454?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-07-09 · How we verify

NCT05095454

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI

Completed NA Results posted Last updated 9 July 2024

What this trial tests

NA trial testing Percutaneous epidural electrical spinal stimulation in Paraplegia in 6 participants. Completed in 30 March 2023.

Timeline

4 March 2022

Primary endpoint
30 March 2023

30 March 2023

Quick facts

Lead sponsor	Kristin Zhao, PhD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	6
Start date	4 March 2022
Primary completion	30 March 2023
Estimated completion	30 March 2023
Sites	1 location across United States

Drugs / interventions tested

Percutaneous epidural electrical spinal stimulation
Transcutaneous electrical spinal stimulation

Conditions studied

Paraplegia — all drugs for Paraplegia →
Tetraplegia — all drugs for Tetraplegia →
Paralysis — all drugs for Paralysis →
Quadraplegia — all drugs for Quadraplegia →

Sponsor

Kristin Zhao, PhD

Who can join

22 and older, any sex, with Paraplegia or Tetraplegia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Electromyography Primary · Through study completion; an average of 5 months.

Change in voltage measurements in major muscle groups below the level of injury. Specifically, change in soleus root mean square voltage during standing with and without stimulation.

Group	Value	95% CI
Percutaneous Epidural Stimulation	0.00017507	± 0.04279603
Transcutaneous Epidural Stimulation	0.00006740	± 0.05917040

Foot Pressure Primary · Beginning of intervention to end of intervention, an average of 17 days.

Change in measurements of foot pressure in kilograms through shoe-insole pressure sensors.

Beginning of intervention

Group	Value	95% CI
Percutaneous Epidural Stimulation	6	± 9
Transcutaneous Epidural Stimulation	0	± 0

End of intervention

Group	Value	95% CI
Percutaneous Epidural Stimulation	40	± 34
Transcutaneous Epidural Stimulation	0	± 0

Somatosensory Evoked Potentials Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurements of change in voltage in the conduction of electricity through the peripheral nerves, cervical and lumbosacral spinal cord, deep brain structures, and sensory cortex, using surface electrodes.

Left sided measurements

Group	Value	95% CI
Percutaneous Epidural Stimulation	0.67	± 0.6
Transcutaneous Epidural Stimulation	0.8	± 0.99

Right sided measurements

Group	Value	95% CI
Percutaneous Epidural Stimulation	0.33	± 0.12
Transcutaneous Epidural Stimulation	0.35	± 0.07

Transcranial Magnetic Stimulation Motor Evoked Potentials Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurement of the threshold percentage change in voltage between pre-intervention and post-intervention in the first trapezius or deltoid muscle activated.

Group	Value	95% CI
Percutaneous Epidural Stimulation	3.33	± 5.77
Transcutaneous Epidural Stimulation	5	± 7.07

Injury Severity: International Standards for Neurological Classification of Spinal Cord Injury Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Change sensory and motor function impairment using the American Spinal Injury Association Impairment Scale. Individuals are classified from A" (complete SCI) to "E" (normal function). 28 dermatomes and 10 key muscles are assessed bilaterally. Summed results produce overall sensory and motor scores and combine with evaluation of anal sensory and motor function in determination of AIS classification. Sensory scores are rated 0 (sensation absent) to 2 (normal), bilaterally for each of 28 dermatomes. Muscle function is rated 0 (total paralysis) to 5 (active movement, full range of motion against s

Change between Complete (C) and Incomplete (I) designations

Group	Value	95% CI
Percutaneous Epidural Stimulation	0
Transcutaneous Epidural Stimulation	0

Change in ASIA Impairment Scale (AIS) rating

Group	Value	95% CI
Percutaneous Epidural Stimulation	0
Transcutaneous Epidural Stimulation	0

Change in sensation of Deep Anal Pressure (DAP)

Group	Value	95% CI
Percutaneous Epidural Stimulation	0
Transcutaneous Epidural Stimulation	0

Change in Voluntary Anal Contraction (VAC)

Group	Value	95% CI
Percutaneous Epidural Stimulation	0
Transcutaneous Epidural Stimulation	0

Patient-reported Bowel Function Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurement of change in bowel function using the Neurogenic Bowel Dysfunction Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bowel symptoms. The total score ranges between 0 and 44 points. A higher total score indicates more severe bowel symptoms.

Group	Value	95% CI
Percutaneous Epidural Stimulation	-4	-6 – -2
Transcutaneous Epidural Stimulation	-3.5	-12 – 5

Patient-reported Bladder Function Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurement of change in bladder function using the Neurogenic Bladder Symptom Score. Answers to qualitative questions are rated from 0 to 5, with a higher number indicating more problematic symptoms, and totaled for a score which categorizes severity of neurogenic bladder symptoms. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms).

Group	Value	95% CI
Percutaneous Epidural Stimulation	-11.3	-12 – -8
Transcutaneous Epidural Stimulation	-4.5	-6 – -3

Male Patient-reported Sexual Function (1) Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurement of change in erectile dysfunction using the Sexual Health Inventory for Men (SHIM). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total score can range from 1 to 25, with a lower number indicating more severe erectile dysfunction.

Group	Value	95% CI
Percutaneous Epidural Stimulation	-6.3	-14 – 2
Transcutaneous Epidural Stimulation	0	-1 – 1

Male Patient-reported Sexual Function (2) Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Measurement of change in erectile dysfunction using the International Index for Erectile Function (IIEF). Answers to qualitative questions are rated from 0 to 5, with a higher number indicating better erectile function, and totaled for a score which categorizes severity of erectile dysfunction. Total scores range from 5 to 25, with a lower score indicating more severe erectile dysfunction.

Group	Value	95% CI
Percutaneous Epidural Stimulation	-23.3	-35 – -11
Transcutaneous Epidural Stimulation	-1.5	-2 – -1

Spasticity Primary · Assessed at Baseline, 4 Weeks, 8 Weeks, and 20 Weeks; change from Baseline at week 20 reported.

Change in measurements of spasticity using the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET). Answers to qualitative questions are rated from -3 to +3, with a higher positive number indicating more helpful symptoms, and a lower negative number indicating more problematic symptoms. Questions may also be answered as not applicable (N/A), which do not generate a score. Scores are totaled for a score which categorizes the overall positive or negative impact of a subject's spasticity symptoms. Total score can range from -105 (negative impact) to +105 (positive impact), and the score is av

Group	Value	95% CI
Percutaneous Epidural Stimulation	0.057	-0.033 – 0.090
Transcutaneous Epidural Stimulation	0.088	-0.207 – 0.383

Neurostimulation User Experience Primary · End of intervention, an average of 4 weeks

Rating of the subject's perception of individual aspects of spinal stimulation using the User Experience Questionnaire (UEQ), a survey including 26 descriptive terms and their antonyms. A scoring scale ranging from 1 to 7 determines how closely the subject feels the term or its antonym applies to the intervention, with lower numbers indicating agreement with the term, and higher numbers indicating agreement with the antonym. The terms and antonyms describe a positive and negative perception of each item. Subscales grouping terms into like categories average scores into a 7 point range from -3

Attractiveness

Group	Value	95% CI
Percutaneous Epidural Stimulation	3	± 0
Transcutaneous Epidural Stimulation	2.5	± 0

Perspicuity

Group	Value	95% CI
Percutaneous Epidural Stimulation	1.5	± 0.707
Transcutaneous Epidural Stimulation	1.917	± 0.382

Efficiency

Group	Value	95% CI
Percutaneous Epidural Stimulation	2.583	± 0.382
Transcutaneous Epidural Stimulation	2	± 0.354

Dependability

Group	Value	95% CI
Percutaneous Epidural Stimulation	2.083	± 0.520
Transcutaneous Epidural Stimulation	1.75	± 0.354

Stimulation

Group	Value	95% CI
Percutaneous Epidural Stimulation	2.917	± 0.144
Transcutaneous Epidural Stimulation	2	± 0.354

Novelty

Group	Value	95% CI
Percutaneous Epidural Stimulation	2.583	± 0.382
Transcutaneous Epidural Stimulation	1.75	± 1.414

Overground Ambulation [as Appropriate to the Subject] Primary · Baseline, 4 Weeks, 8 Weeks, and 20 Weeks

Measurement of changes in overground mobility as measured by the Modified 6 Minute Walk Test. Trainers will assess the distance in meters which the subject can cover in 6 minutes, with a greater distance characterizing better overground mobility.

Pre-intervention to post-intervention

Group	Value	95% CI
Percutaneous Epidural Stimulation	9.2

Pre-intervention to 8 weeks post intervention

Group	Value	95% CI
Percutaneous Epidural Stimulation	16.5

Pre-intervention to 20 weeks post intervention

Group	Value	95% CI
Percutaneous Epidural Stimulation	16.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were assessed over the course of approximately 20 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Percutaneous Epidural Stimulation

Serious: 0/3 (0%)

Deaths: 0/3

Transcutaneous Epidural Stimulation

Serious: 1/3 (33%)

Deaths: 0/3

Serious adverse events (1 terms)

Reaction	System	Percutaneous Epidural Stim…	Transcutaneous Epidural St…
Nephrolithiasis	Renal and urinary disorders	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	Percutaneous Epidural Stim…	Transcutaneous Epidural St…
Urinary tract infection	Renal and urinary disorders	—	—
Orthostatic hypotension	Vascular disorders	—	—
Bowel incontinence	Gastrointestinal disorders	—	—
Petechiae	Skin and subcutaneous tissue disorders	—	—
Urinary incontinence	Renal and urinary disorders	—	—
Serosanguinous drainage	Skin and subcutaneous tissue disorders	—	—
Urethral irritation post urodynamics study	Renal and urinary disorders	—	—
Headache	Nervous system disorders	—	—
Low back pain	Musculoskeletal and connective tissue disorders	—	—
Presyncope	Nervous system disorders	—	—
COVID-19 infection	Respiratory, thoracic and mediastinal disorders	—	—
Skin irritation	Skin and subcutaneous tissue disorders	—	—
Autonomic dysreflexia	Nervous system disorders	—	—
Hemorrhoids	Vascular disorders	—	—

Most-reported serious reactions: Nephrolithiasis.

Data from ClinicalTrials.gov NCT05095454 adverse events section.

Sponsor's own description

A study comparing short-term delivery of epidural spinal stimulation versus transcutaneous spinal stimulation.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Functional outcomes and participants' perspectives during short-term application of spinal stimulation in individuals with spinal cord injury.
Veith DD, Gill ML, Beck LA, Whitmarsh CL, et al · · 2025 · cited 3× · PMID 39172032 · DOI 10.1080/10790268.2024.2383377
Therapy-specific motoneuron activation with epidural and dorsal root ganglion stimulation in spinal cord injury.
Asp AJ, Gill ML, Fernandez KA, Veith DD, et al · · 2026 · PMID 41963069 · DOI 10.1152/jn.00438.2025
ISNCSCI Exam Changes Following Spinal Cord Stimulation.
Solinsky RJ, Veith DD, Gill ML, Beck LA, et al · · 2025 · PMID 40862210 · DOI 10.46292/sci25-00017

Verify or expand the search:

Other recruiting trials for Paraplegia

Currently open trials in the same condition.

NCT06295146 — Virtual Peer Coaching in Manual Wheelchair Skills · NA · recruiting
NCT06294834 — Improving Clinician Capacity to Provide Interventions for Manual Wheelchair Users · NA · active not recruiting
NCT05483764 — Ultrasonographic Measurements of the Achilles Tendon and Talar Condylar Cartilage Thickness in Paraplegia Patients. · active not recruiting
NCT00623389 — Evaluation of an Advanced Lower Extremity Neuroprostheses · NA · recruiting
NCT01474148 — A Neuroprosthesis for Seated Posture and Balance · NA · recruiting

Other Kristin Zhao, PhD trials

Trials by the same sponsor.

NCT06019611 — Epidural Stimulation in Multiple Sclerosis · NA · completed
NCT04627441 — Transcutaneous and Epidural Stimulation in SCI · NA · withdrawn
NCT03768401 — Accessible Mobile Health and Wellness · NA · terminated
NCT03193996 — 4DCT Imaging for Improved Diagnosis and Treatment of Wrist Ligament Injuries · NA · completed
NCT03412656 — Assessing Force Feedback With the SoftHand Pro · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05095454 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Kristin Zhao, PhD
Last refreshed: 9 July 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05095454.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing