MammaplastyNCT03240900
Electrical Stimulation for Improving Postoperative Breast Sensation
A study testing Electrical Stimulation in people with Mammaplasty, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Mammaplasty
- What is being tested?
- Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2027to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Woman aged 18-60 undergoing bilateral, prophylactic nipple/skin-sparing mastectomy with immediate implant reconstruction
Who cannot join
- Smokers
- Preexisting peripheral neuropathy
- Prior breast surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
University of Alberta Hospital
Edmonton, Alberta, T5R2E1
Misericordia Hospital
Edmonton, Alberta, T5R4H5
Ming Chan, (780)-492-1614, ming.chan@ualberta.ca
Ming Chan
About this study
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.
Read the 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.
- Conditions
- Mammaplasty
- Being tested
- Electrical Stimulation, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationDevice
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.
PlaceboProcedure or surgery
This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Electrical Stimulation Breast | Experimental | Breast that will receive 1 hour of intraoperative electrical stimulation Receives: Device: Electrical Stimulation |
| No Electrical Stimulation Breast | Placebo comparator | The contralateral breast of the patient will receive no electrical stimulation Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (1)
Patient Satisfaction
BREAST-Q Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start1 Sep 2027 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming Chan, Principal investigator, Professor University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240900
- Sponsor's protocol ID
- Estim Breast
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be only used by the research team for this study. It will not be shared to other researchers.
Publications
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.
PubMed 23953096Passavanti 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.
PubMed 17094410Chan 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.
PubMed 26864594Gordon T, Brushart TM, Chan KM. Augmenting nerve regeneration with electrical stimulation. Neurol Res. 2008 Dec;30(10):1012-22. doi: 10.1179/174313208X362488.
PubMed 19079975Gordon 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.
PubMed 19800329Chan 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.
PubMed 25220611Dossett 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.
PubMed 27087574Wong 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.
PubMed 25727139
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation for Improving Postoperative Breast Sensation
- ClinicalTrials.gov ID
- NCT03240900
- Acronym / sponsor ID
- Estim Breast
- Conditions
- Mammaplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Sep 2027 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Electrical Stimulation Breast | Experimental | Device: Electrical StimulationBreast that will receive 1 hour of intraoperative electrical stimulation |
| No Electrical Stimulation Breast | Placebo comparator | Procedure: PlaceboThe contralateral breast of the patient will receive no electrical stimulation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Woman aged 18-60 undergoing bilateral, prophylactic nipple/skin-sparing mastectomy with immediate implant reconstruction
Key exclusion criteria (3 listed)
- Smokers
- Preexisting peripheral neuropathy
- Prior breast surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical StimulationElectrical 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. | Device | Electrical Stimulation Breast |
| PlaceboThis breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention. | Procedure or surgery | No Electrical Stimulation Breast |
Primary outcome
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
1 secondary outcome
Patient Satisfaction
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 23953096Gahm 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.
- Background: PubMed 17094410Passavanti 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.
- Background: PubMed 26864594Chan 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.
- Background: PubMed 19079975Gordon T, Brushart TM, Chan KM. Augmenting nerve regeneration with electrical stimulation. Neurol Res. 2008 Dec;30(10):1012-22. doi: 10.1179/174313208X362488.
- Background: PubMed 19800329Gordon 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.
- Background: PubMed 25220611Chan 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.
- Background: PubMed 27087574Dossett 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.
- Results publication: PubMed 25727139Wong 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.
- Individual participant dataSharing planned: No. IPD will be only used by the research team for this study. It will not be shared to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming Chan principal investigator
Professor University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation in people with Mammaplasty, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Chan ((780)-492-1614, ming.chan@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240900, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.