Nervous System Diseases

Heart and Blood Diseases

All Conditions

Stroke

Epilepsy

Brain Diseases

Central Nervous System Diseases

High-density EEG will be used for brain localization in epilepsy patients

High-density EEG will be used for brain localization in healthy controls

High-density EEG will be used for brain localization in tumor patients

High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction

High-density EEG will be used for brain localization in patients who have recently experienced a stroke

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density electroencephalogram (HD-EEG)

The purpose of the study is to use a new method of high-density electroencephalogram (HD-EEG) recording to map brain areas important for movement, sensation, language, emotion, and cognition.

This study will measure brain waves using high-density EEG. Participants will be asked wear a cap with electrodes attached to it. During the recording, participants may be asked to rest, sleep, or complete a task. The tasks involve viewing pictures, answering questions, speaking, or moving an arm or leg. Recordings generally last between 60-120 minutes.\*

High-density EEG in Neurological Disorders

Localize brain functions using high-density EEG recordings

Localize brain areas involved in language using high-density EEG recordings

Localize brain areas involved in movement using high-density EEG recordings

Localize brain areas involved in sensation using high-density EEG recordings

Localize brain areas involved in emotion using high-density EEG recordings

Localize brain areas involved in memory using high-density EEG recordings

Localize brain areas associated with lesions using high-density EEG recordings

Dartmouth-Hitchcock Medical Center

Clinical Neurophysiologist, Neuro Diagnostics

Symptoms and General Pathology

Behaviors and Mental Disorders

Rare Diseases

Pain, Postoperative

Chronic Pain

Pain

Phantom Limb

Sensation Disorders

Hypesthesia

Postoperative Complications

Neurologic Manifestations

Perceptual Disorders

Neurobehavioral Manifestations

Chronic Graft Versus Host Disease

Nipple sparing mastectomy (NSM) and implant reconstruction

Nipple sparing mastectomy (NSM) and autologous reconstruction

Gender mastectomy with free nipple grafting

Control patients matched by surgical procedure, age, BMI and mastectomy weight.

Quantitative sensory testing (QST) will be performed. QST was developed to standardize the noninvasive assessment of the somatosensory nervous system and quantify functioning of all aspects of sensation (light touch, pressure, warm, cold, pain, vibration): 1. Thermal detection (Medoc TSA system): Cold detection threshold B) Warm detection threshold C) Heat pain threshold 2. Mechanical detection threshold (MRC Opti Hair von Frey Filaments) 3. Two-point discrimination (MRC Opti Hair von Frey Filaments) 4. Mechanical pain threshold (MRC Pinprick Stimulator) 5. Pressure pain threshold (Medoc Pressure algometer) 6. Tinel sign on physical exam 7. Vibration (tuning fork)

Sensory testing

Lisa Gfrerer, MD, PhD

Lisa Gfrerer, MD. PhD

During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and connecting them to the nipple and areola. The investigators aim to compare postoperative sensation and patient reported outcomes in patients undergoing reinnervation versus those not undergoing reinnervation to determine if there is a difference. The investigators will investigate this in patients undergoing gender-affirming mastectomy, implant-based breast reconstruction and autologous breast reconstruction. The investigators will use various tools that measure sensation quantitatively.

SIGNIFICANCE

During removal of breast tissue that is required for mastectomy procedures, the nerves that supply the breast skin and the nipple areola complex (NAC) are sacrificed. This results in fair to poor sensation in 50-90% of patients, decreased patient satisfaction and increased risk of injury. Further, when nerves are transected, axons sprout from the proximal free nerve end and form neuromas that cause chronic pain (CP) and phantom pain (PP) in \~60% and 30-80% of patients, respectively. With the implementation of advanced peripheral nerve surgery techniques, it has become possible to preserve, transfer and graft nerves to the insensate areas of the reconstructed breast/chest to provide sensation in cancer and transgender patients. Multiple studies have shown increased patient satisfaction and sensation after reinnervation as compared to no reinnervation. However, there are several limitations to currently published clinical outcome studies: 1)Lack of comprehensive objective outcome measures to test all aspects of the somatosensory nervous system. No study to date has utilized the protocol for Quantitative Sensory Testing (QST) that was developed by the German Research Network on Neuropathic Pain (DFNS) and provides a validated and standardized approach to test all nociceptive and non- nociceptive sensory functions including small unmyelinated C fibers, myelinated A-alpha, A-beta, and A-delta fibers. This comprehensive, standardized and validated approach has been adopted internationally to evaluate sensory conditions and allows for objective outcome assessment and comparison. 2)Gap in knowledge regarding reinnervation outcomes after implant- based reconstruction. Most sensory studies were performed in patients undergoing autologous reconstruction with only few studies discussing reinnervation in the context of implant- based breast reconstruction. However, the most common type of reconstruction after breast cancer remains implant based reconstruction accounting for 80% of breast reconstruction cases. Therefore, it is important to investigate this population further to determine whether reinnervation is successful and should be offered to this patient population. 3)Limited understanding of sensory outcome after transgender mastectomy. Sensory outcome is important to \>90% of patients undergoing transgender mastectomy with free nipple grafting (FNG), which is the most common procedure performed in transgender patients. Our team has described chest reinnervation in this patient population with good sensory outcomes. However, a prospective clinical trial with comprehensive outcome measurements including QST and patient reported outcome measures (PROMs) with control group is required to further examine the role of reinnervation in transgender chest surgery. 4)Insufficient prospective data on PP and CP. There are very few prospective studies reporting the incidence of PP and CP after cancer and transgender mastectomy and the results are inconsistent. Further, the percentage of chronic breast/chest pain patients with true neuropathic pain (NP) is unclear. In addition, although we know from other patient populations (amputees) that nerve reconstruction significantly decreases the incidence of CP and PP, there is no data on whether breast reinnervation influences the percentage of patients who will develop these conditions. 5)Prospective comparison of reinnervation outcomes between autologous reconstruction, implant reconstruction and gender mastectomy has not been performed. Breast reinnervation has rapidly evolved and is becoming a widely employed addition to breast and chest reconstruction. However, it remains unclear how these patient populations compare, and which patients obtain good sensory outcome warranting the longer operative times and higher cost of reinnervation.

The broad objective of this proposal is to prospectively compare objective data on sensory outcomes using QST and PROMs in patients undergoing reinnervation after A) nipple sparing mastectomy (NSM) and implant reconstruction B) NSM and autologous reconstruction C) gender mastectomy with FNG and D) control patients matched by surgical procedure, age, BMI and mastectomy weight. This preliminary data will be used to apply for government funding (NIH K23) to conduct a randomized controlled multi- center clinical trial to evaluate reinnervation versus no reinnervation after mastectomy in cancer and transgender care. The objectives of this larger scale study are to A) obtain objective QST sensory measurements and PROM outcomes across institutions, B) determine the chances of reinnervation success based on variables such as patient factors (age, comorbidities, adjuvant treatment), mastectomy factors (incision type, mastectomy weight), breast reconstruction techniques (retropectoral, prepectoral, direct- to implant, expander reconstruction, implant size, implant type, types of autologous reconstruction), chest reconstruction techniques and nerve transfer techniques (number of nerves, length of allograft, size of allograft etc.) C) perform a cost- benefit analysis and D) develop evidence-based guidelines for breast/ chest reinnervation after mastectomy.

SPECIFIC AIMS

All aims will analyze and compare the following patient groups: a) NSM and implant reconstruction with reinnervation b) NSM with autologous reconstruction with reinnervation c) gender mastectomy with FNG with reinnervation d) controls matched by surgical procedure (implant, autologous, transgender), BMI, age, gender and mastectomy weight.

Aim 1A: Analysis of all aspects of sensation with QST. Aim 1B: Evaluation of timing of return of sensation. Aim 2: Assessment of CP and PP. Aim 3: Analysis of patient satisfaction.

HYPOTHESIS

Breast reinnervation does not improve sensation/patient satisfaction as compared to mastectomy with no reinnervation. Further, there is no difference in prevalence of CP and PP.

Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients

Prospective Cohort Study Comparing Sensory Outcome, Development of Chronic Pain and Phantom Pain, as Well as Patient Satisfaction in Cancer and Transgender Patients Undergoing Mastectomy and Reconstruction With and Without Reinnervation.

All BREAST-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.

All Gender-Q scores range from 0-100. The scores are computed from the responses to the separate questions by adding them together and converting the score to a scale from 0 to 100 (similar to conversion into a percentage). A higher score means high satisfaction or better health-related quality of life.

Thermal detection measured by Medoc TSA system

Measured by MRC Opti Hair von Frey Filaments

Massachusetts General Hospital

Weill Medical College of Cornell University

Neoplasms

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

Semmes-Weinstein testing: Each breast will be subdivided into 5 regions. This will include the upper 1/3rd, the middle 1/3rd medial and lateral to the nipple areola complex, the lower 1/3rd and the nipple areola-complex. These regions are consistent with the dermatomes described for the breast innervation.

A cutaneous nerve/skin biopsy is a simple procedure commonly performed on an outpatient setting. The total procedure is expected to take 20 minutes and may be done at the time of surgery as well as 2 and 6 months post operatively either during a revision or at a follow up visit.

Sensory testing and Biopsy

Scott Hollenbeck, MD

The purpose of this study is to establish techniques for evaluating breast cutaneous sensation at baseline and following either lumpectomy or mastectomy for breast cancer.

Measuring nerve recovery and breast sensibility has been reported in a limited fashion in the past. A number of studies have assessed patients before and after breast reduction surgery using Semmes-Weinstein monofilaments and found this to be an effective technique. A limited number of studies have been done in patients undergoing mastectomy for breast cancer using these techniques. The main limitation of these existing studies is the lack of prospective measurements before surgery and through time, thus restricting the findings to isolated long-term outcomes. Additionally, no studies have compared patients undergoing mastectomy versus lumpectomy to determine the impact that surgical approach has on breast sensibility.

Study to Assess Breast Sensation Before and After Breast Cancer Treatment

Pilot Study to Assess Breast Sensation Before and After Breast Cancer Treatment

change in sensory perception will be conducted using paired t-tests or Wilcoxon tests

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High-density EEG in Neurological Disorders	NCT04266041	Epilepsy Tumor Healthy	High-density el...	18 Years -	Dartmouth-Hitchcock Medical Center
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients	NCT06094257	Sensation Disor... Sensation, Phan... Pain, Postopera... Pain, Chronic Numbness Sensory Disorde... Sensory Defect Phantom Pain Phantom Sensati...	Sensory testing	18 Years -	Weill Medical College of Cornell University
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients	NCT06094257	Sensation Disor... Sensation, Phan... Pain, Postopera... Pain, Chronic Numbness Sensory Disorde... Sensory Defect Phantom Pain Phantom Sensati...	Sensory testing	18 Years -	Weill Medical College of Cornell University
Study to Assess Breast Sensation Before and After Breast Cancer Treatment	NCT02817607	Breast Reconstr... Ductal Carcinom...	Sensory testing...	25 Years - 65 Years	Duke University

Spots Global Cancer Trial Database for sensation

Every month we try and update this database with for sensation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sensation

Every month we try and update this database with for sensation cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sensation cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.