Who is sponsoring NCT04543786?

NCT04543786 is sponsored by University of Pittsburgh.

What drugs are being tested in NCT04543786?

Interventions in NCT04543786: Transcutaneous spinal cord stimulation.

What condition does NCT04543786 study?

NCT04543786 studies Amputation, Phantom Limb Pain, Hoffman's Reflex.

Is NCT04543786 still recruiting?

NCT04543786 is currently terminated. Last updated 24 July 2023.

Are results published for NCT04543786?

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

Last reviewed 2023-07-24 · How we verify

NCT04543786

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

Neuromodulation in Lower Limb Amputees

Terminated NA Results posted Last updated 24 July 2023

What this trial tests

NA trial testing Transcutaneous spinal cord stimulation in Amputation in 3 participants. Terminated before completion.

Timeline

7 March 2022

Primary endpoint
29 June 2022

29 June 2022

Quick facts

Lead sponsor	University of Pittsburgh
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	3
Start date	7 March 2022
Primary completion	29 June 2022
Estimated completion	29 June 2022
Sites	2 locations across United States

Drugs / interventions tested

Transcutaneous spinal cord stimulation

Conditions studied

Amputation — all drugs for Amputation →
Phantom Limb Pain — all drugs for Phantom Limb Pain →
Hoffman's Reflex — all drugs for Hoffman's Reflex →

Sponsor

University of Pittsburgh

Who can join

Adults 21 to 70, any sex, with Amputation or Phantom Limb Pain. 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.

Mean H-reflex Threshold Primary · Day 2

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	NA	± NA

Mean H-reflex Threshold Primary · Day 3

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	NA	± NA

Mean H-reflex Threshold Primary · Day 4

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	NA	± NA

Mean H-reflex Threshold Primary · Day 5

Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	NA	± NA

Mean PRM Reflex Threshold Primary · Day 2

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	56.7	± 4.9

Mean PRM Reflex Threshold Primary · Day 3

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	55.8	± 5.9

Mean PRM Reflex Threshold Primary · Day 4

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	56.2	± 7.6

Mean PRM Reflex Threshold Primary · Day 5

Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	38.6	± 12.2

Phantom Limb Pain Score Secondary · Day 5

McGill Pain Questionnaire: minimum = 0, maximum = 78, the higher the pain score the greater the pain

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	18.3	± 6.8

Pain Pressure Threshold Secondary · Day 5

Pain Pressure Threshold Test using an algometer: minimum force that induces pain, minimum = 0 N, maximum = 444.8 N, a lower threshold indicates hypersensitivity

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	50.67	± 26.07

Pain Score Secondary · Day 2

Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	4.7	± 1.5

Pain Score Secondary · Day 3

Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain

Group	Value	95% CI
Transcutaneous Spinal Cord Stimulation	3.7	± 3.2

Sponsor's own description

The goal of this study is to investigate the role of transcutaneous spinal cord stimulation on spinal cord excitability in lower limb amputees. In this study, the investigators will quantify the spinal cord excitability determined by 1) reflexes and electromyography, and 2) phantom limb pain using self-reported pain assessments. The investigators will assess these measures of spinal excitability in lower limb amputees before and after transcutaneous spinal cord stimulation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

A preliminary study exploring the effects of transcutaneous spinal cord stimulation on spinal excitability and phantom limb pain in people with a transtibial amputation.
Dalrymple AN, Fisher LE, Weber DJ. · · 2024 · cited 8× · PMID 39094627 · DOI 10.1088/1741-2552/ad6a8d

Verify or expand the search:

Other trials of Transcutaneous spinal cord stimulation

Trials testing the same drug.

NCT07298460 — Stimulation-based Therapy to Improve Balance in DCM · Phase 1, PHASE2 · not yet recruiting
NCT07322458 — The Effect of Spinal Cord Stimulation on Orthostatic Hypotension in Parkinsonism and Its Related Mechanisms · NA · not yet recruiting
NCT06801431 — Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury · NA · not yet recruiting
NCT06596369 — Transcutaneous Spinal Cord Stimulation for Upper Extremity Function · Phase 2, PHASE3 · recruiting
NCT06101199 — Combined Therapeutic Air Mixture and Electrical Stimulation to Improve Breathing and Hand Function in Spinal Cord Injury · NA · terminated

Other recruiting trials for Amputation

Currently open trials in the same condition.

NCT07401966 — Amputations in Childhood and Neuropathic Pain · recruiting
NCT07265154 — Gait Training and Artificial Intelligence · NA · recruiting
NCT07263945 — Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes · Phase 1 · recruiting
NCT07347561 — A Comparison of Myoelectric and Bionic Hands · recruiting
NCT07364266 — Analgesic Amputation for Algodystrophy: Feedback From a Case Series · active not recruiting

Other University of Pittsburgh trials

Trials by the same sponsor.

NCT05601206 — Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE · NA · not yet recruiting
NCT06652815 — Cognition, Metacognition, and Stigma in Patients With Suicidal Ideation · not yet recruiting
NCT06474286 — Prucalopride for Cognitive Functioning in Schizophrenia · NA · not yet recruiting
NCT06488469 — Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus · NA · not yet recruiting
NCT06652802 — Effectiveness of Nurse-Conducted Brief Intervention (NCBI) Supplemented With Mobile for Preventing Alcohol Use Disorders · NA · not yet recruiting

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 NCT04543786 (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 University of Pittsburgh
Last refreshed: 24 July 2023

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/NCT04543786.

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

NCT04543786

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Transcutaneous spinal cord stimulation

Other recruiting trials for Amputation

Other University of Pittsburgh trials

Verify against primary sources