Amputation; Lower ExtremityNCT07571239
Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI
A study testing Surgical Implantation in people with Amputation; Lower Extremity and Pain, Persistent Postsurgical, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation; Lower Extremity, Pain, Persistent Postsurgical
- What is being tested?
- Surgical Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Single-Center, Prospective, Within-Subject Study of Altius® Direct Electrical Nerve Stimulation System in Lower Extremity Amputees With Persistent Pain After Targeted Muscle Reinnervation (TMR) and/or Regenerative Peripheral Nerve Interface (RPNI)
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.
- Being tested
- Surgical Implantation
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ImplantationDevice
Also called Altius® Direct Electrical Nerve Stimulation System
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.
| Study group | Role | What they receive |
|---|---|---|
| Adult Lower Extremity (LE) Amputees | Experimental | Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery. Receives: Device: Surgical Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hours Per Day of Prosthesis Use
Participants provide their average hours per day of prosthesis use over the past 7 days.
Measured: Baseline, Month 1, Month 3, Month 6
Change in Days Per Week of Prosthesis Use
Participants provide their average number of days of prosthesis use over the past 7 days.
Measured: Baseline, Month 1, Month 3, Month 6
Change in Prosthesis Function Level
Participants rate their current level of function with their prosthesis on a scale from 1 (extremely low) to 10 (extremely high).
Measured: Baseline, Month 1, Month 3, Month 6
Change in Prosthesis Satisfaction Level
Participants rate their current level of satisfaction with their prosthesis on a scale from 1 (extremely dissatisfied) to 10 (extremely satisfied).
Measured: Baseline, Month 1, Month 3, Month 6
Change in Locomotor Capabilities Index (LCI-5) Score
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.
Measured: Baseline, Month 1, Month 3, Month 6
Secondary outcomes (7)
Change in Patient Health Questionnaire-9 (PHQ-9) Score
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.
Measured: Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Residual Pain
Residual pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Phantom Pain
Phantom pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline, Month 1, Month 3, Month 6
Change in PROMIS Pain Intensity Short Form 8a Score
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.
Measured: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Opioids/Narcotics for Pain
Measured: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Medication for Nerve Pain
Measured: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain
Measured: Baseline, Month 1, Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Lower ExtremityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Hacquebord, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571239
- Sponsor's protocol ID
- 26-00331
- Status last verified
- Apr 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective, Within-Subject Study of Altius® Direct Electrical Nerve Stimulation System in Lower Extremity Amputees With Persistent Pain After Targeted Muscle Reinnervation (TMR) and/or Regenerative Peripheral Nerve Interface (RPNI)
- ClinicalTrials.gov ID
- NCT07571239
- Acronym / sponsor ID
- 26-00331
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Lower Extremity (LE) Amputees | Experimental | Device: Surgical ImplantationAdult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
- Unable to participate in follow-ups according to study schedule (1 month, 3 months, and 6 months post-op)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ImplantationAlso: Altius® Direct Electrical Nerve Stimulation SystemThe 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. | Device | Adult Lower Extremity (LE) Amputees |
Primary outcome
Change in Hours Per Day of Prosthesis Use
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Residual Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Phantom Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Change in PROMIS Pain Intensity Short Form 8a Score
Time frame: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Opioids/Narcotics for Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Medication for Nerve Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain
Time frame: Baseline, Month 1, Month 3, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacques Hacquebord, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Implantation in people with Amputation; Lower Extremity and Pain, Persistent Postsurgical, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacques Hacquebord, MD (646-413-9861, Jacques.Hacquebord@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hours Per Day of Prosthesis Use (time frame: Baseline, Month 1, Month 3, Month 6). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.