Electrical Stimulation for Improving Postoperative Breast Sensation

NCT03240900 | Not Yet Recruiting

• 1 other identifier: Estim Breast
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Mammaplasty

Outcome Measures

Primary Outcomes (1)

• Sensation

  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 Outcomes (1)

• Patient Satisfaction

  12 months

Study Arms (2)

Electrical Stimulation Breast

EXPERIMENTAL

Breast that will receive 1 hour of intraoperative electrical stimulation

Device: Electrical Stimulation

No Electrical Stimulation Breast

PLACEBO COMPARATOR

The contralateral breast of the patient will receive no electrical stimulation

Procedure: Placebo

Interventions

Electrical Stimulation DEVICE

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.

Electrical Stimulation Breast

Placebo PROCEDURE

This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.

No Electrical Stimulation Breast

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Women undergoing prophylactic bilateral skin/nipple-sparing mastectomy with immediate implant-based breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Smokers
• Preexisting peripheral neuropathy
• Prior breast surgery

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (2)

University of Alberta Hospital

Edmonton, Alberta, T5R2E1, Canada

Location

Misericordia Hospital

Edmonton, Alberta, T5R4H5, Canada

Location

Related Publications (8)

• Gahm J, Hansson P, Brandberg Y, Wickman M. Breast sensibility after bilateral risk-reducing mastectomy and immediate breast reconstruction: a prospective study. J Plast Reconstr Aesthet Surg. 2013 Nov;66(11):1521-7. doi: 10.1016/j.bjps.2013.06.054. Epub 2013 Aug 13.

  PMID: 23953096 BACKGROUND

• Passavanti MB, Pace MC, Barbarisi A, D'Andrea F, Grella E, Nicoletti GF, Aurilio C. Pain and sensory dysfunction after breast cancer surgery: neurometer CPT evaluation. Anticancer Res. 2006 Sep-Oct;26(5B):3839-44.

  PMID: 17094410 BACKGROUND

• Chan KM, Curran MW, Gordon T. The use of brief post-surgical low frequency electrical stimulation to enhance nerve regeneration in clinical practice. J Physiol. 2016 Jul 1;594(13):3553-9. doi: 10.1113/JP270892. Epub 2016 Mar 24.

  PMID: 26864594 BACKGROUND

• Gordon T, Brushart TM, Chan KM. Augmenting nerve regeneration with electrical stimulation. Neurol Res. 2008 Dec;30(10):1012-22. doi: 10.1179/174313208X362488.

  PMID: 19079975 BACKGROUND

• Gordon T, Amirjani N, Edwards DC, Chan KM. Brief post-surgical electrical stimulation accelerates axon regeneration and muscle reinnervation without affecting the functional measures in carpal tunnel syndrome patients. Exp Neurol. 2010 May;223(1):192-202. doi: 10.1016/j.expneurol.2009.09.020. Epub 2009 Oct 1.

  PMID: 19800329 BACKGROUND

• Chan KM, Gordon T, Zochodne DW, Power HA. Improving peripheral nerve regeneration: from molecular mechanisms to potential therapeutic targets. Exp Neurol. 2014 Nov;261:826-35. doi: 10.1016/j.expneurol.2014.09.006. Epub 2014 Sep 16.

  PMID: 25220611 BACKGROUND

• Dossett LA, Lowe J, Sun W, Lee MC, Smith PD, Jacobsen PB, Laronga C. Prospective evaluation of skin and nipple-areola sensation and patient satisfaction after nipple-sparing mastectomy. J Surg Oncol. 2016 Jul;114(1):11-6. doi: 10.1002/jso.24264. Epub 2016 Apr 18.

  PMID: 27087574 BACKGROUND

• Wong JN, Olson JL, Morhart MJ, Chan KM. Electrical stimulation enhances sensory recovery: a randomized controlled trial. Ann Neurol. 2015 Jun;77(6):996-1006. doi: 10.1002/ana.24397. Epub 2015 May 4.

  PMID: 25727139 RESULT

MeSH Terms

Interventions

Electric Stimulation

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Ming Chan

  Professor University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Chan

CONTACT

(780)-492-1614; ming.chan@ualberta.ca

Jenna-Lynn Senger

CONTACT

780-906-7221; jennalynn@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the surgeon will be aware of the laterality of the intervention. The patient will not be performed. All outcomes will be assessed by the investigators, who will be masked to the laterality until the completion of the study when the surgeon will unmask.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will receive the intervention to one breast and not the other, therefore acting as their own internal control. The laterality of the intervention will be randomized by a coin flip.

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: August 7, 2017
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)