Electrical Stimulation for Post-Mastectomy Sensation Improvement

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help women regain sensation in reconstructed breasts after a mastectomy. The focus is on using electrical stimulation (a mild electrical current) to improve sensation, often lost after surgery. Eligible participants include women undergoing bilateral mastectomy with immediate implants, provided they do not smoke and have not had prior breast surgery. Researchers will test one breast with electrical stimulation while leaving the other unchanged to determine if this method can restore feeling. The goal is to improve quality of life by making reconstructed breasts feel more natural. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance post-mastectomy recovery.

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 prior data suggests that this electrical stimulation technique is safe for improving sensation after mastectomy?

Research shows that electrical stimulation (ES) is a safe and manageable treatment for improving nerve function. Previous studies demonstrated that ES aids in nerve healing after injury. This method has enhanced feeling in areas affected by surgery, such as carpal tunnel procedures.

Additionally, other studies found that a similar technique, transcutaneous electrical nerve stimulation, can greatly reduce pain after breast cancer surgery. These findings suggest that ES is generally well-tolerated with few side effects.

While this study doesn't provide specific safety details for its use of ES, the treatment's proven success and safety in nerve-related therapies are promising. Participants considering this trial should feel reassured by the existing research supporting the safety of ES in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using electrical stimulation to improve sensation after a mastectomy because it offers a novel approach to a challenging problem. Traditional options like physical therapy or surgical interventions often focus on managing symptoms rather than directly enhancing nerve regrowth. Electrical stimulation, however, targets the nerves directly, potentially promoting faster and more effective nerve regeneration. This method could lead to improved sensory recovery, giving patients a more complete post-surgical experience than current therapies typically provide.

What evidence suggests that electrical stimulation is effective for improving sensation after mastectomy?

Research has shown that electrical stimulation (ES) can aid in nerve healing and regrowth. This technique has successfully improved sensation in injured nerves, such as those in the hands. In this trial, one group will receive electrical stimulation to the breast to assess its effectiveness in reducing pain and potentially restoring sensation after mastectomy. For individuals who have undergone mastectomies, ES has reduced post-surgical pain. The concept is that ES promotes nerve regrowth, which could restore feeling in the breast after reconstruction. Although this application is still under study, early results appear promising. ^{1 2 3 6 7}

Who Is on the Research Team?

Ming Chan

Principal Investigator

Professor University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11729116/

The healing power of transcutaneous electrical nerve stimulation Transcutaneous electrical stimulation has significantly alleviated pain associated with breast cancer surgery.

2. withpower.com withpower.com/trial/phase-11-2017-60f1b

Electrical Stimulation for Post-Mastectomy Sensation ... The effectiveness of FS-TENS improved with increased usage, with 57.1% of high-utilization users experiencing clinically meaningful reductions in pain ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S108994722100352X

Effects of Transcutaneous Electrical Nerve Stimulation on ... Conclusions. Our study results suggest that TENS reduces MRM pain. Thus, TENS can be recommended as a useful analgesic method in MRM.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9513569/

Effectiveness of Neuromuscular Electrical Stimulation for ... The NMES device provided a potential clinical benefit of helping to enhance recovery after surgery. THA is ranked 11th among the most painful ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06964438

Postoperative Electrical Muscle Stimulation Two The main objective of this trial is to assess whether neuromuscular stimulation (NMES) can minimise muscle loss following abdominal surgery for cancer; and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10728246/

Postmastectomy Functional Impairments - PubMed Central - NIH This narrative review aims to offer a thorough summary of functional impairments commonly encountered by breast cancer survivors following ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1877065722000963

Effects of mechanical stimulation on mastectomy scars ... This study aimed to investigate the effects of mechanical stimulation on scar appearance, arm function, and quality of life of breast cancer survivors after ...