NCT04543786

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 24, 2023

Completed
Last Updated

July 24, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

July 6, 2020

Results QC Date

May 1, 2023

Last Update Submit

June 29, 2023

Conditions

AmputationPhantom Limb PainHoffman's Reflex

Keywords

ElectromyographyElectrical StimulationTranscutaneous Spinal Cord StimulationPosterior Root-Muscle Reflex

Outcome Measures

Primary Outcomes (8)

  • Mean H-reflex Threshold

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

    Day 2

  • Mean H-reflex Threshold

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

    Day 3

  • Mean H-reflex Threshold

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

    Day 4

  • Mean H-reflex Threshold

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

    Day 5

  • Mean PRM Reflex Threshold

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

    Day 2

  • Mean PRM Reflex Threshold

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

    Day 3

  • Mean PRM Reflex Threshold

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

    Day 4

  • Mean PRM Reflex Threshold

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

    Day 5

Secondary Outcomes (6)

  • Phantom Limb Pain Score

    Day 5

  • Pain Pressure Threshold

    Day 5

  • Pain Score

    Day 2

  • Pain Score

    Day 3

  • Pain Score

    Day 4

  • +1 more secondary outcomes

Study Arms (1)

Transcutaneous spinal cord stimulation

EXPERIMENTAL

Transcutaneous spinal cord stimulation on lower back for 30-60 minutes for 5 consecutive days.

Device: Transcutaneous spinal cord stimulation

Interventions

Transcutaneous spinal cord stimulationDEVICE

Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.

Transcutaneous spinal cord stimulation

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be between the ages of 21 and 70 years old.
  • Participants must have a trans-tibial amputation and phantom limb pain in at least one leg

You may not qualify if:

  • Participants must not have any serious disease, disorder, or infection (ex. blood or bone disorder or infection) that could affect their ability to participate in this study.
  • Female participants of child-bearing potential must not be pregnant or breast feeding, or plan to become pregnant during the course of the study.
  • Participants must not have any implanted stimulators or pulse generators
  • Participants must not have any implanted metallic devices in their torso and/or legs
  • Participants must not have heart disease, including known arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Carnegie Mellon University

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • Dalrymple AN, Fisher LE, Weber DJ. A preliminary study exploring the effects of transcutaneous spinal cord stimulation on spinal excitability and phantom limb pain in people with a transtibial amputation. J Neural Eng. 2024 Aug 22;21(4):10.1088/1741-2552/ad6a8d. doi: 10.1088/1741-2552/ad6a8d.

    PMID: 39094627DERIVED

MeSH Terms

Conditions

Phantom LimbReflex, Abnormal

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPain

Results Point of Contact

Title
Lee Fisher
Organization
University of Pittsburgh
lef44@pitt.edu
412-383-1329

Study Officials

  • Lee Fisher, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor

Study Record Dates

First Submitted

July 6, 2020

First Posted

September 10, 2020

Study Start

March 7, 2022

Primary Completion

June 29, 2022

Study Completion

June 29, 2022

Last Updated

July 24, 2023

Results First Posted

July 24, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

We may share de-identified data with researchers at other centers for the purpose of data analysis and collaboration. We currently do not have a data sharing plan; however, if we decide to share data in the future, we will contact the Office of Sponsored Projects to determine whether an agreement is needed. Study sponsors will have access to research data and documents in order to monitor the integrity of the study.

Time Frame
After publication of results. We currently do not have a data sharing plan; however, if we decide to share data in the future, we will contact the Office of Sponsored Projects to determine whether an agreement is needed.
Access Criteria
We currently do not have a data sharing plan; however, if we decide to share data in the future, we will contact the Office of Sponsored Projects to determine whether an agreement is needed.

Locations

US(2)