Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

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

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Matthew J Carty, MD
617-983-4555
mcarty@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Matthew J Carty, MD
617-983-4555
mcarty@bwh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.