Recruiting

Modified Amputation

Sponsor:

Brigham and Women's Hospital

Code:

NCT07831278

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

amputation or revision procedure with additional RPNI construction

Study Details

Brief summary:

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.

Conditions

Amputation

Study ID

NCT07831278

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Surgical Intervention - RPNI Construction

Subjects undergoing the proposed operative intervention with associated follow up testing

Interventions

amputation or revision procedure with additional RPNI construction

amputation or revision procedure in which additional RPNIs (regenerative peripheral nerve interfaces) are created beyond what would be included in a standard care procedure

Primary outcome measure

  • Co-Contraction Interference Measure [ Time Frame: from operative intervention to 12 months postop ]

Central Contacts and Locations

Central contacts

Matthew J Carty, MD

617-983-4555mcarty@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Matthew J Carty, MD

617-983-4555mcarty@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • amputation
  • amputation revision
  • residual limb pain
  • phantom pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.