Amputation; Lower Extremity, Pain, Persistent Postsurgical
Conditions
Brief summary
This is a single-center, prospective, within-subject study. This study seeks to enroll a total of 32 prospective subjects who will undergo surgical implantation of the FDA-approved Altius® system. Subjects will be followed longitudinally and will complete a series of patient-reported outcome measure questionnaires, a study intake questionnaire which assesses demographics, amputation and prosthesis history, and medical/medication history.
Interventions
DEVICESurgical Implantation
The Altius system will be surgically implanted into the patient on one occasion. The Altius system is then used on an 'as needed' basis by patient.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years old) * Lower extremity amputees with prior TMR, RPNI at least 9 months prior to enrollment, or similar nerve-targeted surgery who have persistent neuropathic pain * Persistent chronic/intractable neuropathic pain that is moderate to severe (VAS ≥4) * 50% or greater pain reduction after receiving SOC ultrasound-guided lidocaine injection * Able and willing to provide consent
Exclusion criteria
* Non-LE amputees * LE amputees without moderate to significant pain * LE amputees who have not undergone TMR, RPNI, or similar nerve targeted surgeries, amputees who have undergone these surgeries less than 9 months prior to enrollment, or amputees who have undergone these surgeries and do not have persistent pain * Patients with contraindications to implant surgery * Presence of any active implantable device (e.g, pacemaker, implantable cardioverter-defibrillator, other neurostimulator or drug pump) * Anticipated need for MRI or diathermy after implantation * Uncontrolled diabetes, defined as HbA1c \> 8.0 at screening due to increased risk of surgical complications and delayed wound healing * Pregnant, breastfeeding, intending pregnancy during the study period, or unwilling to use effective contraception * Suspected or known allergy to any component of the Altius system or to lidocaine used for the diagnostic lidocaine block. * Severe scarring, skin grafting, or other anatomic constraints over the planned implant site that would prevent safe placement of the cuff electrode(s), lead(s), or IPG * Spasticity of the residual limb preventing comfortable full range of motion, which may interfere with stability or comfort of the implanted leads. * Other significant pain syndromes that, in the investigator's judgment, would likely confound assessment of phantom limb or residual limb neuropathic pain outcomes. * Active substance abuse; severe psychiatric illness that may interfere with study participation (e.g., recent psychiatric hospitalization or other condition that impairs ability to comply with study procedures); or inability to comply with follow up visits or operation of the Altius Direct Electrical Nerve Stimulation System. * Uncontrolled infection at the amputation site or bleeding disorders * Unable to operate the Altius® Direct Electrical Nerve Stimulation System * Unsuitable for the Altius implant surgery * Unable to participate in follow-ups according to study schedule (1 month, 3 months, and 6 months post-op)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hours Per Day of Prosthesis Use | Baseline, Month 1, Month 3, Month 6 | Participants provide their average hours per day of prosthesis use over the past 7 days. |
| Change in Days Per Week of Prosthesis Use | Baseline, Month 1, Month 3, Month 6 | Participants provide their average number of days of prosthesis use over the past 7 days. |
| Change in Prosthesis Function Level | Baseline, Month 1, Month 3, Month 6 | Participants rate their current level of function with their prosthesis on a scale from 1 (extremely low) to 10 (extremely high). |
| Change in Prosthesis Satisfaction Level | Baseline, Month 1, Month 3, Month 6 | Participants rate their current level of satisfaction with their prosthesis on a scale from 1 (extremely dissatisfied) to 10 (extremely satisfied). |
| Change in Locomotor Capabilities Index (LCI-5) Score | Baseline, Month 1, Month 3, Month 6 | 14-item assessment of locomotor capabilities; each item is rated on a 5-point scale from 0 to 4; the total score is the sum of responses and ranges from 0-56; higher scores indicate greater locomotor capabilities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire-9 (PHQ-9) Score | Baseline, Month 1, Month 3, Month 6 | 9-item assessment of depressive symptoms; each item is rated on a scale from 0-3; the total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depressive symptoms. |
| Change in Visual Analogue Score (VAS) - Residual Pain | Baseline, Month 1, Month 3, Month 6 | Residual pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Change in Visual Analogue Score (VAS) - Phantom Pain | Baseline, Month 1, Month 3, Month 6 | Phantom pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Change in PROMIS Pain Intensity Short Form 8a Score | Baseline, Month 1, Month 3, Month 6 | The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 8a is an 8-item assessment of pain interference in daily life. Each item is rated on a scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses; the raw score is converted to a standardized score ranging from 0-100 with a mean of 50; higher scores indicate more pain interference. |
| Number of Participants Taking Opioids/Narcotics for Pain | Baseline, Month 1, Month 3, Month 6 | — |
| Number of Participants Taking Medication for Nerve Pain | Baseline, Month 1, Month 3, Month 6 | — |
| Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain | Baseline, Month 1, Month 3, Month 6 | — |
Countries
United States
Contacts
CONTACTJacques Hacquebord, MD
CONTACTAnne Genzelev
PRINCIPAL_INVESTIGATORJacques Hacquebord, MD
NYU Langone Health
Outcome results
None listed