Electrical Stimulation for Improving Postoperative Breast Sensation

Starting soon · Not applicable · Has a placebo group

Conditions studied: Mammaplasty

In brief

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.

Key facts

Study ID
NCT03240900
Run by
University of Alberta
People needed
30
Starts
2027-09-01
Expected to finish
2028-11-30
Last updated by the study team
2026-02-06

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

You may not qualify if…

Where it is running

Full record on ClinicalTrials.gov

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