Health TrialsbyHealthPanel

Training Independent Muscle Activation From a Common Source

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• 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

Trial design

Design model

Single group

Treatments tested in this trial

  • amputation or revision procedure with additional RPNI construction

    Procedure/Surgery

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Surgical Intervention - RPNI ConstructionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Co-Contraction Interference Measure

Degree of co-contraction interference or crosstalk between RPNIs, modeled by fitting an exponential decay fit to task error over time or repetitions

Time frame
from operative intervention to 12 months postop

Secondary outcomes

1

Task Performance Measure - Success Rate

Task success rate, measured by the mean squared error between intended and actual movement paths.

Time frame
from operative intervention to 12 months postop
2

Task Performance Measure - Speed

Task completion speed, measured by the mean squared error between intended and actual movement

Time frame
immediately post intervention to 12 months postop
3

Task Performance Measure - Participant Controllability

Participant controllability over task, measured by the mean squared error between intended and actual movement paths.

Time frame
immediately post intervention to 12 months postop

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Harvard University

Collaborator

Source ClinicalTrials.gov
Apply now