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
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.
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transcutaneous spinal cord stimulation on lower back for 30-60 minutes for 5 consecutive days.
Device: Transcutaneous spinal cord stimulation
Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
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
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
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
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
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
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
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
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
Phantom Limb Pain Score
McGill Pain Questionnaire: minimum = 0, maximum = 78, the higher the pain score the greater the pain
Time frame: Day 5
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
Pain Score
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
Time frame: Day 2
Pain Score
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
Time frame: Day 3
Pain Score
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
Time frame: Day 4
Pain Score
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
Time frame: Day 5
| Milestone | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean H-reflex Threshold | NA ± NA |
Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean H-reflex Threshold | NA ± NA |
Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean H-reflex Threshold | NA ± NA |
Reflex threshold: stimulation amplitude required to evoke reflex response. The presence of H-reflexes are expected in uninjured individuals.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean H-reflex Threshold | NA ± NA |
Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean PRM Reflex Threshold | 56.7 ± 4.9 |
Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean PRM Reflex Threshold | 55.8 ± 5.9 |
Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean PRM Reflex Threshold | 56.2 ± 7.6 |
Reflex threshold: stimulation amplitude required to evoke reflex response. Thresholds in uninjured people have been reported to be approximately 30 mA.
| mA | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean PRM Reflex Threshold | 38.6 ± 12.2 |
McGill Pain Questionnaire: minimum = 0, maximum = 78, the higher the pain score the greater the pain
| Score on a Scale | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Phantom Limb Pain Score | 18.3 ± 6.8 |
Pain Pressure Threshold Test using an algometer: minimum force that induces pain, minimum = 0 N, maximum = 444.8 N, a lower threshold indicates hypersensitivity
| Newton | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Pain Pressure Threshold | 50.67 ± 26.07 |
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
| Score on a Scale | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Pain Score | 4.7 ± 1.5 |
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
| Score on a Scale | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Pain Score | 3.7 ± 3.2 |
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
| Score on a Scale | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Pain Score | 4.8 ± 1.0 |
Visual analog scale: minimum = 0, maximum = 10, the higher the score the greater the pain
| Score on a Scale | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Pain Score | 4.5 ± 0.5 |
Collected over 5 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Transcutaneous Spinal Cord Stimulation | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Sex/Gender, Customized(Participants) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Gender — Man | 2 |
| Gender — Woman | 1 |
| Race (NIH/OMB)(Participants) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| United States | 3 |
| H-reflex threshold(mA) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean | NA ± NA |
| PRM threshold(mA) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean | 59.5 ± 6.1 |
| Phantom limb pain score(Score on a Scale) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean | 34 ± 7 |
| Pain pressure threshold(Newton) | Transcutaneous Spinal Cord Stimulation |
|---|---|
| Mean | 23.84 ± 13.08 |
4 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
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.
This study is terminated, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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