ClinicalTrials.gg
TerminatedNCT04543786Updated Jul 24, 2023Results posted

Neuromodulation in Lower Limb Amputees

An interventional study of Transcutaneous spinal cord stimulation in Amputation, Phantom Limb Pain and Hoffman's Reflex, sponsored by University of Pittsburgh. Terminated at 2 sites in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by University of Pittsburgh · Not applicable, Interventional, and Basic science

Why this study was terminated
Funding ended
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
21 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

The overall goal of this work is to investigate the changes in the spinal cord resulting from limb amputation. Limb amputation results in an extreme form of peripheral nerve injury. Damage to peripheral nerves, such as with neuropathy, crush injuries, nerve transection, or limb amputation often results in chronic pain, which may be associated with altered excitability of spinal sensorimotor pathways. These spinal pathways become hyperexcitable due to a lack of sensory input, which causes tonic disinhibition of descending circuits and spontaneous activity in the dorsal root ganglia (DRG). Spinal excitability can be measured using the H-reflex, in which electrical stimulation of muscle spindle Ia afferents activates spinal motoneurons via the myotatic reflex, as well as the posterior root-muscle (PRM) reflex, which is elicited by transcutaneous stimulation over the dorsal roots and is considered to be half of the H-reflex, excluding the peripheral primary afferents, but with multiple root activation. Spinal excitability has not been measured in amputees but may offer a potential biomarker for PLP. Neuromodulation may restore normal spinal excitability and reduce PLP, thus offering the potential to improve the quality of life in individuals with a lower limb amputation. The results of this study will provide the foundation for future development of a neuroprosthesis to restore spinal excitability and reduce PLP in individuals with a lower limb amputation. Subjects will undergo 5 testing and stimulation sessions in 1 week. An additional 3 days of recording sessions may be necessary if a phantom limb pain episode does not occur during normal testing days.

Specific Aim 1: Quantify spinal excitability. A lack of sensory input results in spinal hyperexcitability through several pathways including tonic disinhibition of descending circuits and spontaneous activity in the DRG. Spinal cord excitability is directly related to reflex modulation; impaired or enhanced reflex modulation indicates abnormal spinal cord excitability. Spinal cord excitability will be determined in people with a lower limb amputation using the H-reflex and posterior root-muscle (PRM) reflex. The H-reflex is elicited with electrical stimulation of peripheral nerves, exciting muscle spindle Ia afferents projecting to spinal motoneurons via the myotatic reflex. Stimulation of the peripheral nerves also elicits a direct motor (M) wave. The PRM reflex is elicited by electrical stimulation of the posterior roots on the back. It is considered to be half of the H-reflex, excluding the peripheral motor efferents, but activates multiple dorsal roots. Reflex amplitude and latency, threshold, recruitment curves, and rate-dependent depression will be measured and compared to intact controls. The investigators hypothesize that H and PRM reflex hyperexcitability will be present in the residual limb of amputees with PLP. These results will provide insight into the role of limb amputation on spinal cord health and excitability.

Specific Aim 2: Characterize the effects of transcutaneous spinal cord stimulation on spinal cord excitability and phantom limb pain.

Neuromodulation of sensorimotor pathways using transcutaneous electrical nerve stimulation (TENS), dorsal root ganglia stimulation (DRGS), and epidural spinal cord stimulation (eSCS) to reduce phantom limb pain have been explored with mixed results. The most promising methods for pain reduction were DRGS or laterally-placed eSCS, indicating that the DRG and dorsal roots are optimal targets for reducing PLP. However, these methods require surgical implantation of electrodes. Transcutaneous spinal cord stimulation (tSCS) is a non-invasive method for stimulating the dorsal roots in a similar way as eSCS. Through activation of the primary afferents, tSCS may inhibit pain pathways and reduce the hyperexcitability that leads to chronic pain. tSCS in people with spinal cord injury has been shown to restore spinal inhibition and reduce H-reflex hyperexcitability. The investigators hypothesize that tSCS can reduce PLP through modulation of sensorimotor pathways. By comparing the H- and PRM reflex excitability recorded from the residual limb before and after each session of tSCS, a potential mechanism of PLP could be elucidated. H- and PRM reflex modulation, and any differences in the extent of modulation for each, can further inform on the mechanisms of tSCS and how it modulates sensorimotor pathways. The investigators will also quantify the subjects' experience of PLP before and after the 5 days of tSCS and correlate their pain experiences with spinal excitability measures. The investigators will use a visual analog scale and the McGill Pain Questionnaire to assess changes in pain perception. The investigators will also use an algometer to determine changes in local pain threshold.

02

Conditions studied

  • Amputation
  • Phantom Limb Pain
  • Hoffman's Reflex

Keywords

  • Electromyography
  • Electrical Stimulation
  • Transcutaneous Spinal Cord Stimulation
  • Posterior Root-Muscle Reflex
03

In context

Phantom Limb

163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.

This study's enrollment of 3 is below the median of 30 across 125 interventional studies indexed under Phantom Limb.

Browse Phantom Limb studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 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

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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 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
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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Transcutaneous spinal cord stimulation

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

    Device: Transcutaneous spinal cord stimulation

Interventions

  • DeviceTranscutaneous spinal cord stimulation

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

06

What researchers measure

Primary outcomes

  1. Mean H-reflex Threshold

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

    Time frame: Day 2

  2. Mean H-reflex Threshold

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

    Time frame: Day 3

  3. Mean H-reflex Threshold

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

    Time frame: Day 4

  4. Mean H-reflex Threshold

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

    Time frame: Day 5

  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.

    Time frame: Day 2

  6. 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.

    Time frame: Day 3

  7. 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.

    Time frame: Day 4

  8. 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.

    Time frame: Day 5

Secondary outcomes

  1. Phantom Limb Pain Score

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

    Time frame: Day 5

  2. Pain Pressure Threshold

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

    Time frame: Day 5

  3. Pain Score

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

    Time frame: Day 2

  4. Pain Score

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

    Time frame: Day 3

  5. Pain Score

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

    Time frame: Day 4

  6. Pain Score

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

    Time frame: Day 5

07

Results

Posted Jul 24, 2023

Participant flow

Participant flow — Overall Study
MilestoneTranscutaneous Spinal Cord Stimulation
Started3
Completed3
Not completed0

Outcome measures

PrimaryMean H-reflex Threshold

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

Time frame:
Day 2
Reported as:
Mean · mA
Mean H-reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean H-reflex ThresholdNA ± NA
PrimaryMean H-reflex Threshold

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

Time frame:
Day 3
Reported as:
Mean · mA
Mean H-reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean H-reflex ThresholdNA ± NA
PrimaryMean H-reflex Threshold

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

Time frame:
Day 4
Reported as:
Mean · mA
Mean H-reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean H-reflex ThresholdNA ± NA
PrimaryMean H-reflex Threshold

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

Time frame:
Day 5
Reported as:
Mean · mA
Mean H-reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean H-reflex ThresholdNA ± NA
PrimaryMean PRM Reflex Threshold

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

Time frame:
Day 2
Reported as:
Mean · mA
Mean PRM Reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean PRM Reflex Threshold56.7 ± 4.9
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = 0.0048 (Bonferroni post-hoc tests; p \< 0.05 was considered significant) · Mean difference (final values): 2.8One-way
PrimaryMean PRM Reflex Threshold

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

Time frame:
Day 3
Reported as:
Mean · mA
Mean PRM Reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean PRM Reflex Threshold55.8 ± 5.9
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = < 0.001 (Bonferroni post-hoc tests; p \< 0.05 was considered significant) · Mean difference (final values): 3.72
PrimaryMean PRM Reflex Threshold

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

Time frame:
Day 4
Reported as:
Mean · mA
Mean PRM Reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean PRM Reflex Threshold56.2 ± 7.6
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = <0.001 (Bonferroni post-hoc tests; p \< 0.05 was considered significant) · Mean difference (final values): 3.24
PrimaryMean PRM Reflex Threshold

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

Time frame:
Day 5
Reported as:
Mean · mA
Mean PRM Reflex Threshold
mATranscutaneous Spinal Cord Stimulation
Mean PRM Reflex Threshold38.6 ± 12.2
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = <0.001 (Bonferroni post-hoc tests; p \< 0.05 was considered significant) · Mean difference (final values): 20.84
SecondaryPhantom Limb Pain Score

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

Time frame:
Day 5
Reported as:
Mean · Score on a Scale
Phantom Limb Pain Score
Score on a ScaleTranscutaneous Spinal Cord Stimulation
Phantom Limb Pain Score18.3 ± 6.8
SecondaryPain Pressure Threshold

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

Time frame:
Day 5
Reported as:
Mean · Newton
Pain Pressure Threshold
NewtonTranscutaneous Spinal Cord Stimulation
Pain Pressure Threshold50.67 ± 26.07
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · t-test, 2 sided · p = <0.001 (p \< 0.05 was considered significant) · Mean difference (final values): 26.78paired
SecondaryPain Score

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

Time frame:
Day 2
Reported as:
Mean · Score on a Scale
Pain Score
Score on a ScaleTranscutaneous Spinal Cord Stimulation
Pain Score4.7 ± 1.5
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = 0.56 (p \< 0.05 was considered significant) · Mean difference (final values): 1.3Repeated measures
SecondaryPain Score

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

Time frame:
Day 3
Reported as:
Mean · Score on a Scale
Pain Score
Score on a ScaleTranscutaneous Spinal Cord Stimulation
Pain Score3.7 ± 3.2
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = 0.56 (p \< 0.05 was considered significant) · Mean difference (final values): 2.3Repeated measures
SecondaryPain Score

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

Time frame:
Day 4
Reported as:
Mean · Score on a Scale
Pain Score
Score on a ScaleTranscutaneous Spinal Cord Stimulation
Pain Score4.8 ± 1.0
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = 0.56 (p \< 0.05 was considered significant) · Mean difference (final values): 1.2Repeated measures
SecondaryPain Score

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

Time frame:
Day 5
Reported as:
Mean · Score on a Scale
Pain Score
Score on a ScaleTranscutaneous Spinal Cord Stimulation
Pain Score4.5 ± 0.5
Statistical analysis
  • Transcutaneous Spinal Cord Stimulation · ANOVA · p = 0.56 (p \< 0.05 was considered significant) · Mean difference (final values): 1.5Repeated measures

Adverse events

Collected over 5 days. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Transcutaneous Spinal Cord Stimulation0/3 (0%)0/3 (0%)0/3 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Transcutaneous Spinal Cord Stimulation
<=18 years0
Between 18 and 65 years3
>=65 years0
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Transcutaneous Spinal Cord Stimulation
Gender — Man2
Gender — Woman1
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Transcutaneous Spinal Cord Stimulation
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White3
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Transcutaneous Spinal Cord Stimulation
United States3
H-reflex threshold
H-reflex threshold(mA)Transcutaneous Spinal Cord Stimulation
MeanNA ± NA
PRM threshold
PRM threshold(mA)Transcutaneous Spinal Cord Stimulation
Mean59.5 ± 6.1
Phantom limb pain score
Phantom limb pain score(Score on a Scale)Transcutaneous Spinal Cord Stimulation
Mean34 ± 7
Pain pressure threshold
Pain pressure threshold(Newton)Transcutaneous Spinal Cord Stimulation
Mean23.84 ± 13.08

4 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • Carnegie Mellon University
    Pittsburgh, Pennsylvania 15213, United States
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15260, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04543786
Responsible party
Lee Fisher, PhD (PhD, Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Sep 10, 2020
Start date
Mar 7, 2022
Primary completion
Jun 29, 2022
Completion
Jun 29, 2022
Results posted
Jul 24, 2023
Last update
Jul 24, 2023

Study contacts

Lee Fisher, PhD
principal investigator · University of Pittsburgh

Oversight

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

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