Electrical Stimulation for Improving Postoperative Breast Sensation

March 8, 2024 updated by: University of Alberta

Described as the "Angelina Jolie Effect", rates of prophylactic mastectomy with immediate implant-based reconstruction are increasing dramatically as more women with genetic predisposition towards breast cancer are seeking surgical prevention. Advances in surgical techniques allow for the creation of an aesthetically pleasing postoperative breast mound; however, a common complaint is the lack of sensation to the skin and nipple of the reconstructed breast due to injury and stretch of the sensory nerves. Numbness of the breast, nipple, and areola is an unnatural feeling for the patient, as well as a potential risk for injury or burns as the woman is unable to feel pain.

Our laboratory has previously shown that electrical stimulation (ES) is an effective way of improving nerve regeneration after injury to the nerves of the upper and lower extremities. Proven to improve motor outcomes following carpal and cubital tunnel release and sensation following injury to the digital nerves, this technique is a likely mechanism of restoring sensation of the breast as well.

In this study, we will follow thirty women undergoing prophylactic skin-sparing mastectomy with immediate implant-based reconstruction. At the time of surgery, patients will be randomly assigned ES to either the right or left breast. That breast will be reconstructed first and stimulated for one hour while the other breast is reconstructed. At the completion of the case, all wires will be removed. We will test sensation (tactile, temperature, 2-point discrimination, sharp/dull discrimination, and protective sensation) prior to surgery then again at 6, 12, 18, and 24 months following surgery to evaluate the effects of ES on sensory return. Patients will be provided with a survey to assess return of erogenous sensation.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Objective: To determine whether intraoperative electrical stimulation enhances sensory recovery following mastectomy with immediate implant reconstruction

Background: There is an increasing trend towards prophylactic mastectomy with immediate implant-based reconstruction for women with genetics predisposing to breast cancer (BRCA-1 and -2). Novel techniques such as fat grafting and nipple creation/tattooing have contributing towards creating an aesthetically pleasing breast mound; however, the majority of women experience non-recoverable significant sensory loss secondary to damage and stretch of the intercostal nerves that provide sensation to the skin, areola, and nipple. Most women will recover minimal sensation around the perimeter of the breast, indicating a potential for sensory return; however, particularly the nipple usually remains numb. An insensate breast feels unnatural to the woman and predisposes her to injury and burns of the reconstruction, which can require additional surgery or cause significant scarring.

Our laboratory has previously shown that electrical stimulation (ES) is safe and significantly improves postoperative outcomes in peripheral nerve injury in animal and human models. ES has been shown to improve return of median and ulnar nerve function following carpal and cubital tunnel release respectively, with improved motor outcomes. Sensory return following digital nerve laceration repair similarly is improved with immediate postoperative ES for one hour.

Methods: Thirty patients that will be undergoing bilateral prophylactic skin-sparing mastectomy with immediate implant-based breast reconstruction will be identified from the practice of two plastic surgeons. Preoperatively, women will be undergo sensory testing to the 4 quadrants of both breasts and the nipples, including testing for tactile sensation, cool detection, 2-point discrimination, heat-pain detection threshold, and sharp-blunt discrimination. A custom-made survey to evaluate erogenous sensation will be completed by the patient, as well as the validated BREAST-Q.

The day of surgery the patient will be randomized to right or left breast for stimulation. Following the mastectomy, the breast to be stimulated will be reconstructed with an implant first in the typical fashion. A percutaneous needle will be passed into the intercostal space alongside the 4th intercostal nerve, and a second needle will be inserted into the serratus anterior muscle . These needles will be attached to the anode and cathode respectively of our electrical stimulator, and the patient will receive 1 hour of intraoperative stimulation titrated to palpable contraction of the intercostal muscle. During this hour, the second breast will undergo reconstruction with no electrical stimulation. At the completion of the hour, the skin will be closed in the normal fashion. The laterality will be blinded to the patient as well as to the investigator who will perform all sensory testing.

Postoperatively, the patient will be evaluated at 1 week, 6 months, 12 months, 18 months and 24 months with the same sensory testing as described previously. Patients will serve as their own internal control, and the sensation of the right vs. left breast will be compared. At the completion of all 2-year evaluations, the study will be unblinded and the stimulated vs. non-stimulated breast outcomes will be compared.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R2E1
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T5R4H5
        • Misericordia Hospital
        • Contact:
        • Principal Investigator:
          • Ming Chan
        • Sub-Investigator:
          • Jenna-Lynn Senger
        • Sub-Investigator:
          • Blair Mehling
        • Sub-Investigator:
          • Paul Schembri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Woman aged 18-60 undergoing bilateral, prophylactic nipple/skin-sparing mastectomy with immediate implant reconstruction

Exclusion Criteria:

  • Smokers
  • Preexisting peripheral neuropathy
  • Prior breast surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical Stimulation Breast
Breast that will receive 1 hour of intraoperative electrical stimulation
Device: Electrical Stimulation
Electrical stimulation - a needle attached to an cathode polarity will be placed within the intercostal space near the 4th intercostal nerve. A second needle attached to the anode polarity will be inserted into the serratus anterior muscle. Both electrodes will then be attached to a Grass SD9 stimulator and the voltage and frequency of the stimulation will be titrated to the point where contraction of the intercostal muscles is palpable. It will be maintained at this level for one hour at which point the wires will be removed. This technique is part of the standard of care for peripheral nerve surgeries of the extremities and is proven to be safe in humans.
Placebo Comparator: No Electrical Stimulation Breast
The contralateral breast of the patient will receive no electrical stimulation
Procedure: Placebo
This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensation
Time Frame: 12 months
sensory testing to the 4 quadrants of both breasts and the nipples, including testing for tactile sensation, cool detection, 2-point discrimination, heat-pain detection threshold, and sharp-blunt discrimination
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 12 months
BREAST-Q Questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Investigators

  • Principal Investigator: Ming Chan, Professor University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

August 4, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Estim Breast

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be only used by the research team for this study. It will not be shared to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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