What this study is
In this study, the investigators are evaluating a new surgical technique that may allow participants to control their muscles in a new way after their amputation or revision surgery. The investigators are looking for people who have limb amputation or require a revision operation to a previous amputation. Participants must be over 18 and younger than 65, willing to begin participation within two weeks of their surgery, and be willing to travel regularly to Boston.
In this study, participants will have a modified revision procedure on their amputated limb or a modified amputation procedure, followed by a series of follow up visits in clinic and to a gait lab at Harvard. Participants will also use a wearable device on their limb at home to complete daily training tasks and games.
What's being tested
- amputation or revision procedure with additional RPNI construction
Intervention · PROCEDURE
amputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure
Study details
- Sponsor
- Brigham and Women's Hospital
- Conditions
- Amputation
- Enrolling
- 10 people
- Starts
- 2026-09
- Est. completion
- 2028-08-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18-65
- Fluent in English
- Approved for and scheduled to undergo acute amputation or revision amputation surgery (e.g. above-knee amputation with sciatic nerve ablation) OR sciatic nerve ablation for clinical indications (e.g. persistent pain, symptomatic neuroma, soft tissue breakdown, muscle atrophy, socket-related discomfort).
- Willing and able to initiate participation within 14 days of surgery
- Willing to perform at home studies
- Possess adequate cognitive and communication abilities to describe their sensorimotor recovery during follow-up assessments
- Demonstrate appropriate motivation and reliability to comply with scheduled training and evaluation sessions throughout the postoperative period
- Able to travel to BWH/BWFH and Harvard University for all required visits without lodging support
You can't join if
- Passive or active metal implants incompatible with EMG
- Pacemakers, deep brain stimulators, or other electronic implantables
- Pregnancy or breastfeeding
- Current seizure disorder or other neurologically limiting conditions
- Cognitive or developmental disorders that limit task comprehension
- Vascular disorders impeding regeneration
- Known impairments in wound healing, including connective tissue disorders or under chronic systemic corticosteroid therapy
- Extensive peripheral neuropathies that may hinder neural regeneration and functional RPNI development
- Active smoker
- Are unable to provide informed consent
- Have a demonstrated history of poor protocol adherence
- Pregnant at the time of screening
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (2)
2 openBrigham and Women's Hospital
Boston, Massachusetts, United States
- Matthew J Carty, MD · Contact617-983-4555mcarty@bwh.harvard.edu
RecruitingHarvard University
Cambridge, Massachusetts, United States
- Shriya Srinivasan, PhD · Contact617-495-3675shriya_srinivasan@fas.harvard.edu
- Jennifer Leestma, PhD · Contactjleestma@seas.harvard.edu
- Shriya Srinivasan, PhD · Principal investigator
Not yet recruiting
Study team
Sponsor
Brigham and Women's Hospital
Study ID 2025P002165
Principal investigator
Matthew J Carty, MD
Brigham and Women's Hospital
Principal investigator
Shriya Srinivasan, PhD
Harvard University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.