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)
Sponsor study identifier
interventional
32
1 country
1
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 30, 2026
Actual (reported)May 6, 2026
Actual (reported)July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Hours Per Day of Prosthesis Use
Participants provide their average hours per day of prosthesis use over the past 7 days.
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.
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).
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).
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.
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Residual Pain
Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Phantom Pain
Baseline, Month 1, Month 3, Month 6
Change in PROMIS Pain Intensity Short Form 8a Score
Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Opioids/Narcotics for Pain
Baseline, Month 1, Month 3, Month 6
Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Langone Health
New York, New York, 10016, United States
Jacques Hacquebord, MD
NYU Langone Health
First Submitted
April 30, 2026
First Posted
May 6, 2026
Study Start
July 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 1, 2028
EstimatedBaseline, Month 1, Month 3, Month 6
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 6, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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