<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03240900</url>
  </required_header>
  <id_info>
    <org_study_id>Estim Breast</org_study_id>
    <nct_id>NCT03240900</nct_id>
  </id_info>
  <brief_title>Electrical Stimulation for Improving Postoperative Breast Sensation</brief_title>
  <official_title>Electrical Stimulation for Improving Postoperative Breast Sensation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Described as the &quot;Angelina Jolie Effect&quot;, rates of prophylactic mastectomy with immediate&#xD;
      implant-based reconstruction are increasing dramatically as more women with genetic&#xD;
      predisposition towards breast cancer are seeking surgical prevention. Advances in surgical&#xD;
      techniques allow for the creation of an aesthetically pleasing postoperative breast mound;&#xD;
      however, a common complaint is the lack of sensation to the skin and nipple of the&#xD;
      reconstructed breast due to injury and stretch of the sensory nerves. Numbness of the breast,&#xD;
      nipple, and areola is an unnatural feeling for the patient, as well as a potential risk for&#xD;
      injury or burns as the woman is unable to feel pain.&#xD;
&#xD;
      Our laboratory has previously shown that electrical stimulation (ES) is an effective way of&#xD;
      improving nerve regeneration after injury to the nerves of the upper and lower extremities.&#xD;
      Proven to improve motor outcomes following carpal and cubital tunnel release and sensation&#xD;
      following injury to the digital nerves, this technique is a likely mechanism of restoring&#xD;
      sensation of the breast as well.&#xD;
&#xD;
      In this study, we will follow thirty women undergoing prophylactic skin-sparing mastectomy&#xD;
      with immediate implant-based reconstruction. At the time of surgery, patients will be&#xD;
      randomly assigned ES to either the right or left breast. That breast will be reconstructed&#xD;
      first and stimulated for one hour while the other breast is reconstructed. At the completion&#xD;
      of the case, all wires will be removed. We will test sensation (tactile, temperature, 2-point&#xD;
      discrimination, sharp/dull discrimination, and protective sensation) prior to surgery then&#xD;
      again at 6, 12, 18, and 24 months following surgery to evaluate the effects of ES on sensory&#xD;
      return. Patients will be provided with a survey to assess return of erogenous sensation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To determine whether intraoperative electrical stimulation enhances sensory&#xD;
      recovery following mastectomy with immediate implant reconstruction&#xD;
&#xD;
      Background: There is an increasing trend towards prophylactic mastectomy with immediate&#xD;
      implant-based reconstruction for women with genetics predisposing to breast cancer (BRCA-1&#xD;
      and -2). Novel techniques such as fat grafting and nipple creation/tattooing have&#xD;
      contributing towards creating an aesthetically pleasing breast mound; however, the majority&#xD;
      of women experience non-recoverable significant sensory loss secondary to damage and stretch&#xD;
      of the intercostal nerves that provide sensation to the skin, areola, and nipple. Most women&#xD;
      will recover minimal sensation around the perimeter of the breast, indicating a potential for&#xD;
      sensory return; however, particularly the nipple usually remains numb. An insensate breast&#xD;
      feels unnatural to the woman and predisposes her to injury and burns of the reconstruction,&#xD;
      which can require additional surgery or cause significant scarring.&#xD;
&#xD;
      Our laboratory has previously shown that electrical stimulation (ES) is safe and&#xD;
      significantly improves postoperative outcomes in peripheral nerve injury in animal and human&#xD;
      models. ES has been shown to improve return of median and ulnar nerve function following&#xD;
      carpal and cubital tunnel release respectively, with improved motor outcomes. Sensory return&#xD;
      following digital nerve laceration repair similarly is improved with immediate postoperative&#xD;
      ES for one hour.&#xD;
&#xD;
      Methods: Thirty patients that will be undergoing bilateral prophylactic skin-sparing&#xD;
      mastectomy with immediate implant-based breast reconstruction will be identified from the&#xD;
      practice of two plastic surgeons. Preoperatively, women will be undergo sensory testing to&#xD;
      the 4 quadrants of both breasts and the nipples, including testing for tactile sensation,&#xD;
      cool detection, 2-point discrimination, heat-pain detection threshold, and sharp-blunt&#xD;
      discrimination. A custom-made survey to evaluate erogenous sensation will be completed by the&#xD;
      patient, as well as the validated BREAST-Q.&#xD;
&#xD;
      The day of surgery the patient will be randomized to right or left breast for stimulation.&#xD;
      Following the mastectomy, the breast to be stimulated will be reconstructed with an implant&#xD;
      first in the typical fashion. A percutaneous needle will be passed into the intercostal space&#xD;
      alongside the 4th intercostal nerve, and a second needle will be inserted into the serratus&#xD;
      anterior muscle . These needles will be attached to the anode and cathode respectively of our&#xD;
      electrical stimulator, and the patient will receive 1 hour of intraoperative stimulation&#xD;
      titrated to palpable contraction of the intercostal muscle. During this hour, the second&#xD;
      breast will undergo reconstruction with no electrical stimulation. At the completion of the&#xD;
      hour, the skin will be closed in the normal fashion. The laterality will be blinded to the&#xD;
      patient as well as to the investigator who will perform all sensory testing.&#xD;
&#xD;
      Postoperatively, the patient will be evaluated at 1 week, 6 months, 12 months, 18 months and&#xD;
      24 months with the same sensory testing as described previously. Patients will serve as their&#xD;
      own internal control, and the sensation of the right vs. left breast will be compared. At the&#xD;
      completion of all 2-year evaluations, the study will be unblinded and the stimulated vs.&#xD;
      non-stimulated breast outcomes will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2023</start_date>
  <completion_date type="Anticipated">November 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Sensation</measure>
    <time_frame>12 months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>BREAST-Q Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Mammaplasty</condition>
  <arm_group>
    <arm_group_label>Electrical Stimulation Breast</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Breast that will receive 1 hour of intraoperative electrical stimulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Electrical Stimulation Breast</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The contralateral breast of the patient will receive no electrical stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Electrical Stimulation</intervention_name>
    <description>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.</description>
    <arm_group_label>Electrical Stimulation Breast</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.</description>
    <arm_group_label>No Electrical Stimulation Breast</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman aged 18-60 undergoing bilateral, prophylactic nipple/skin-sparing mastectomy&#xD;
             with immediate implant reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Preexisting peripheral neuropathy&#xD;
&#xD;
          -  Prior breast surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women undergoing prophylactic bilateral skin/nipple-sparing mastectomy with immediate implant-based breast reconstruction</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Chan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor University of Alberta</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ming Chan</last_name>
    <phone>(780)-492-1614</phone>
    <email>ming.chan@ualberta.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jenna-Lynn Senger</last_name>
    <phone>780-906-7221</phone>
    <email>jennalynn@ualberta.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Alberta Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5R2E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Misericordia Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5R4H5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <contact>
      <last_name>Ming Chan</last_name>
      <phone>(780)-492-1614</phone>
      <email>ming.chan@ualberta.ca</email>
    </contact>
    <investigator>
      <last_name>Ming Chan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jenna-Lynn Senger</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Blair Mehling</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Paul Schembri</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23953096</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17094410</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26864594</PMID>
  </reference>
  <reference>
    <citation>Gordon T, Brushart TM, Chan KM. Augmenting nerve regeneration with electrical stimulation. Neurol Res. 2008 Dec;30(10):1012-22. doi: 10.1179/174313208X362488.</citation>
    <PMID>19079975</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19800329</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>25220611</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>27087574</PMID>
  </reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>25727139</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will be only used by the research team for this study. It will not be shared to other researchers.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240900
org study id: Estim Breast
nct id: NCT03240900
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Single Group Assignment
intervention 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.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: 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.
measure: Sensation
time frame: 12 months
description: 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
measure: Patient Satisfaction
time frame: 12 months
description: BREAST-Q Questionnaire
arm group label: Electrical Stimulation Breast
arm group type: Experimental
description: Breast that will receive 1 hour of intraoperative electrical stimulation
arm group label: No Electrical Stimulation Breast
arm group type: Placebo Comparator
description: The contralateral breast of the patient will receive no electrical stimulation
intervention type: Device
intervention name: Electrical Stimulation
description: 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.
arm group label: Electrical Stimulation Breast
intervention type: Procedure
intervention name: Placebo
description: This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.
arm group label: No Electrical Stimulation Breast
criteria: 
gender: Female
gender based: Yes
gender description: Women undergoing prophylactic bilateral skin/nipple-sparing mastectomy with immediate implant-based breast reconstruction
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ming Chan
role: Principal Investigator
affiliation: Professor University of Alberta
last name: Ming Chan
phone: (780)-492-1614
email: ming.chan@ualberta.ca
last name: Jenna-Lynn Senger
phone: 780-906-7221
email: jennalynn@ualberta.ca
facility: 
facility: 
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Canada
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
citation: 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
responsible party type: Sponsor
sharing ipd: No
ipd description: IPD will be only used by the research team for this study. It will not be shared to other researchers.