Electrical Stimulation for Post-Mastectomy Sensation Improvement

Recruiting at 1 trial location

Overseen By Ming Chan

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ming Chan

Disqualifiers: Smokers, Peripheral neuropathy, Prior breast surgery

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

30 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment for improving sensation after a mastectomy?

Research shows that transcutaneous electrical nerve stimulation (TENS), a type of electrical stimulation, is effective in reducing pain after mastectomy surgery and can improve patient outcomes. Additionally, TENS has been shown to improve tactile sensitivity in other conditions, suggesting it may help with sensation improvement. ^{1 2 3 4 5}

Is electrical stimulation generally safe for humans?

Electrical stimulation techniques like NMES and TENS have been used safely for various conditions, but they can cause discomfort and may interfere with certain medical devices like implantable cardioverter defibrillators (ICDs). Safety should be individually assessed, especially for those with specific medical devices. ^{6 7 8 9 10}

How does electrical stimulation treatment differ from other treatments for post-mastectomy sensation improvement?

Electrical stimulation, such as TENS, is unique because it is a non-drug method that uses electrical currents to reduce pain and improve outcomes after mastectomy. It can also enhance blood flow and reduce skin flap necrosis, which are not typically addressed by standard pain medications. ^{2 11 12 13 14}

Research Team

Ming Chan

Principal Investigator

Professor University of Alberta

Eligibility Criteria

This trial is for women aged 18-60 planning to have preventive mastectomy with immediate breast reconstruction due to a high risk of breast cancer. They must not have had previous breast surgeries, be current smokers, or suffer from preexisting nerve damage in the periphery of their body.

Inclusion Criteria

I am a woman aged 18-60 planning a preventive double mastectomy with immediate implant reconstruction.

Exclusion Criteria

I have had breast surgery before.

I have nerve damage in my hands or feet.

Smokers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Patients undergo prophylactic mastectomy with immediate implant-based reconstruction. One breast receives 1 hour of intraoperative electrical stimulation.

1 day

1 visit (in-person)

Postoperative Follow-up

Patients are evaluated with sensory testing at 1 week, 6 months, 12 months, 18 months, and 24 months post-surgery to assess sensory return.

24 months

5 visits (in-person)

Long-term Follow-up

Comparison of sensory outcomes between stimulated and non-stimulated breasts after 2 years.

2 years

Treatment Details

Interventions

• Electrical Stimulation

Trial Overview The study tests if electrical stimulation (ES) can improve sensation in breasts after reconstructive surgery. Half the participants will receive ES on one breast during surgery and sensation will be compared between both breasts at several intervals up to two years post-surgery.

Participant Groups

Group I: Electrical Stimulation Breast Experimental Treatment 1 Intervention

Breast that will receive 1 hour of intraoperative electrical stimulation

Group II: No Electrical Stimulation Breast Placebo Group 1 Intervention

The contralateral breast of the patient will receive no electrical stimulation

Electrical Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Stimulation for:

• Pain relief
• Muscle strengthening
• Rehabilitation after injury or surgery
• Neurological disorders
• Wound healing

Approved in European Union as Electrical Stimulation for:

• Pain management
• Muscle rehabilitation
• Neurological conditions
• Wound care

Approved in Canada as Electrical Stimulation for:

• Chronic pain
• Muscle atrophy
• Neurological rehabilitation
• Wound healing

Who Is Running the Clinical Trial?

Ming Chan

Lead Sponsor

Trials

2

Recruited

70+

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

A study involving 713 chronic pain patients showed that fixed-site high-frequency transcutaneous electrical nerve stimulation (FS-TENS) significantly reduced pain intensity and interference with daily activities and mood after 60 days of use.

The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain interference, highlighting the importance of consistent application for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. Kong, X., Gozani, SN.[2022]

In a study involving patients with multiple sclerosis, transcutaneous electrical nerve stimulation (TENS) applied for 3 weeks significantly improved hand sensitivity, achieving levels comparable to healthy individuals.

The increased tactile sensitivity was not only localized to the treated median nerve area but also extended to the ulnar nerve area, indicating a broader impact of TENS on sensory function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term TENS treatment improves tactile sensitivity in MS patients. Cuypers, K., Levin, O., Thijs, H., et al.[2010]

In a study involving 10 adults, neuromuscular electrical stimulation (NMES) with a 200-microsecond pulse duration allowed participants to tolerate significantly greater muscle torques compared to a 50-microsecond pulse duration, indicating enhanced efficacy for muscle strengthening.

The findings suggest that medium pulse durations may be more effective for maximizing muscle torque responses, despite the common belief that shorter pulses are preferable due to lower pain thresholds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. Scott, WB., Causey, JB., Marshall, TL.[2014]

Neuroprostheses (NPs) have evolved from early muscle stimulators to advanced devices that can effectively activate paralyzed muscles, with functional electrical stimulation (FES) showing significant benefits in enhancing muscle function, particularly in conditions like foot drop.

Recent advancements in technology have made these devices more convenient and reliable, leading to improved therapeutic outcomes, although challenges remain in enhancing upper limb function compared to lower limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. Prochazka, A.[2019]

In a pilot study involving 20 patients with cancer pain, transcutaneous electrical nerve stimulation (TENS) was found to be safe, with 85% of patients using intensity-modulated TENS (IMT) reporting at least slight pain improvement compared to 50% with placebo TENS (PBT).

However, the overall change in average pain intensity did not significantly differ between IMT and PBT, suggesting that while TENS may be desired by patients, it may not provide greater analgesic effects than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. Siemens, W., Boehlke, C., Bennett, MI., et al.[2021]

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.

The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Nussbaum, EL., Houghton, P., Anthony, J., et al.[2019]

Neuromuscular electrical stimulation (NMES) can effectively increase thigh muscle strength and endurance in heart failure patients, but its use must be carefully monitored due to potential electromagnetic interference (EMI) with implantable cardioverter-defibrillators (ICDs).

In a study of eight patients with ICDs, EMI was detected in three subjects during NMES, particularly when stimulating the neck and thighs, highlighting the need for individualized safety assessments for NMES in patients with ICDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electromagnetic interference by transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. Crevenna, R., Stix, G., Pleiner, J., et al.[2022]

In a study involving 24 young adults, sensory transcutaneous electrical nerve stimulation (TENS) did not significantly reduce discomfort during neuromuscular electrical stimulation or enhance the strength of muscle contractions.

Participants reported more discomfort from the muscle contractions themselves than from the electrical current, indicating that TENS may not be effective for alleviating discomfort in this context, and further research is needed to explore different stimulation parameters in patients with medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. Laufer, Y., Tausher, H., Esh, R., et al.[2016]

A novel externally applied neuromuscular electrical stimulation (NMES) device significantly reduced leakage in women with stress urinary incontinence (SUI), showing an impressive 97.71% decrease in leakage after eight weeks of treatment.

The study involved nine women who used the device at home for 30 minutes, four times a week, and demonstrated improvements in pelvic floor muscle contractions and overall muscle strength, indicating that NMES can be an effective noninvasive treatment for SUI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel externally applied neuromuscular stimulator for the treatment of stress urinary incontinence in women--€”a pilot study. Maher, RM., Caulfield, B.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Effectiveness of fixed-site high-frequency transcutaneous electrical nerve stimulation in chronic pain: a large-scale, observational study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of Transcutaneous Electrical Nerve Stimulation on Mastectomy Pain, Patient Satisfaction, and Patient Outcomes. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Long-term TENS treatment improves tactile sensitivity in MS patients. [2010]

4. United States pubmed.ncbi.nlm.nih.gov

A novel approach using electroacupuncture for erectile dysfunction after radical prostatectomy: A case report. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Peripheral Nerve Stimulation: The Evolution in Pain Medicine. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of maximum tolerated muscle torques produced by 2 pulse durations. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Motor Neuroprostheses. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Electromagnetic interference by transcutaneous neuromuscular electrical stimulation in patients with bipolar sensing implantable cardioverter defibrillators: a pilot safety study. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of transcutaneous electrical nerve stimulation on postmastectomy skin flap necrosis. [2009]

12. England pubmed.ncbi.nlm.nih.gov

Characterization of evoked tactile sensation in forearm amputees with transcutaneous electrical nerve stimulation. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Sensory transcutaneous electrical stimulation fails to decrease discomfort associated with neuromuscular electrical stimulation in healthy individuals. [2016]

14. United States pubmed.ncbi.nlm.nih.gov

A novel externally applied neuromuscular stimulator for the treatment of stress urinary incontinence in women--€”a pilot study. [2022]