Electrical Stimulation for Improving Postoperative Breast Sensation

ConditionMammaplasty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-60
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Smokers

Preexisting peripheral neuropathy

Prior breast surgery

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • Placebo

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Electrical Stimulation BreastExperimental treatment 1 intervention
Group B: No Electrical Stimulation BreastPlacebo comparator 1 intervention

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

Patient Satisfaction

BREAST-Q Questionnaire

Time frame
12 months

Other outcomes

Sponsors and contacts

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