A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy (NCT06382272) | Clinical Trial Compass
RecruitingNot Applicable
A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy
United States8 participantsStarted 2025-05-14
Plain-language summary
This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
* 18 years of age or older
* Scheduled for bilateral mastectomy with two-stage (tissue expander) reconstruction at UCM
* Bilateral mastectomy for unilateral in situ or T1to T2, clinically, N0 (no lymph node involvement) breast cancer or breast cancer risk reduction due to known elevated breast cancer risk. (Note - 19-34% of women choosing mastectomy for small unilateral breast cancer elect bilateral mastectomy.)40 We will enroll from this cohort.
* Agrees to have breast tissue expander removed within 12-20 weeks of implantation.
* Has access to a cell phone and willing to provide the research interviewer with the cell phone number
* Agrees to receive text messages from the study
* Able to speak and understand English or Spanish
* Able to participate in the informed consent process
Exclusion criteria:
* Requires adjuvant chemotherapy
* Single stage mastectomy and reconstruction procedure
* Clinical evidence of bilateral breast cancer
* Clinical evidence of lymph node involvement
* Prior history of mastectomy or other major breast surgery
* Prior history of radiation to the chest area (e.g., mantle radiation for Hodgkin's disease)
* Prior history of injury (e.g., trauma, surgery, burn) that the participant perceives to have had an effect on the sensation of the breast
* Pregnant or intending to become pregnant during the study period
* Pacemaker, defibrillator or other implanted electrical stimulation device that may be affected by the implanted electrode…
What they're measuring
1
Psychophysical tasks to assess stimulation-elicited sensation
Timeframe: 7 months after mastectomy+implantation and removal of device