Training Independent Muscle Activation From a Common Source

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT07831278
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • amputation or revision procedure with additional RPNI construction — 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

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.

Key Dates

First listed
Sep 21, 2026
Start date
Sep 30, 2026
Status verified
Sep 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Surgical Intervention - RPNI Construction
    Subjects undergoing the proposed operative intervention with associated follow up testing

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Matthew J Carty, MD
[email protected]
617-983-4555
Harvard UniversityCambridgeMassachusetts02138
Shriya Srinivasan, PhD
[email protected]
617-495-3675
Jennifer Leestma, PhD
[email protected]
Shriya Srinivasan, PhD (PRINCIPAL_INVESTIGATOR)

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Brigham and Women's Hospital· Boston, MAHarvard University· Cambridge, MA

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