Neoplasms

All Conditions

Nervous System Diseases

Rare Diseases

Glioma

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Andrea Szelenyi, MD PhD

Michael Sabel, MD PhD

Jan Vesper, MD PhD

Stefan Schu, MD

Lutz Weise, MD

During neurosurgical resection of brain tumors within brain areas for motor control, it is important to monitor motor function. For this muscle motor evoked potentials are used. Those are elicited by transcranial and direct cortical stimulation. Motor responses are recorded from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used, but additionally motor activity is recorded from the spinal cord. This is called spinal motor evoked potentials. It is known that the relation between spinal and muscle motor evoked potentials helps to extent the resection of spinal cord tumors. This study implements the spinal motor evoked potential into brain tumor surgery and analyses the relationship between spinal and muscle motor evoked potentials. With this, detection of injury to the brain area for motor control might be discovered earlier and thus tumor resection can be performed safely.

Spinal Motor Evoked Potentials in Brain Surgery

Spinal Motor Evoked Potentials During Neurosurgical Procedures Within the Central Region

numeric assessment, amplitude and latency of D-wave

clinical motor status according to the MRC scheme

Johann Wolfgang Goethe University Hospital

Heinrich-Heine University, Duesseldorf

Professor

Symptoms and General Pathology

Gland and Hormone Related Diseases

Recurrence

Thyroid Neoplasms

Thyroid Diseases

Paralysis

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery.

Patients randomized to this arm will undergo total thyroidectomy as per standard procedures with visual identification of the RLNs

The standardized technique of IONM-RLNs (bilaterally) will be used, including indirect vagal response evaluation at the beginning and also at the end of surgery according to the recommendations formulated by the International Intraoperative Neural Monitoring Study Group (INMSG) (Randolph GW, Dralle H. 2011).

IONM tube

Gouri Pantvaidya, MS,DNB,MRCS

Scientific objectives:

Primary objective:

• To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery

Secondary objectives:

* To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers
* To assess voice parameters in patients with RLN palsy

Methodology:

All patients undergoing total thyroidectomy with or without central compartment neck dissection, for thyroid cancers, will be eligible for participation. After confirmation of eligibility and obtaining informed consent, all patients will undergo preoperative screening procedures. Fibreoptic laryngoscopy (FOL) examination will be done to document function of the vocal cords. Preoperative voiceevaluation, GRBAS voice scale assessment and Voice Related Quality of Life (VR-QOL) assessment will be performed for all patients. Patients will then be randomized in a 1:1 ratio to receive IONM or not during surgery. Patients will be stratified as per predefined stratification factors. After surgery, endpoint assessment of vocal cord mobility will be done with a FOL study, by an assessor blinded to the randomization arm. Voice evaluation, GRBAS scale assessment and VR QOL assessment will also be done. An event will be defined as any vocal fold paresis/palsy. Patients without the event will be followed up for 6 months while patients with the event will be followed up for 2 years to assess recovery of vocal cord function and changes in speech parameters. All patients with vocal cord paresis/palsy will be given speech and swallowing rehabilitation

Background and rationale of the study:

The incidence of the thyroid carcinoma has dramatically increased in the last few decades.1Total thyroidectomy with or without central compartment dissection is the treatment of choice for thyroid carcinoma. Vocal cord palsy (VCP) due to injury to the recurrent laryngeal nerve (RLN) is one of the most dreaded complications of this surgery. The symptoms associated with this complication include hoarseness of voice, voice fatigue and aspiration. Vocal cord palsy can be either temporary or permanent. The reported incidence of temporary VCP varies from 0-12%.2-4 However, the incidence of permanent VCP has been reported to be much lower varying from 0 to 3.5%.4,5Many patients may not present with symptoms of hoarseness and a post-operative laryngoscopic examination is required in all patients who have undergone surgery for thyroid cancer.6 However, the morbidity associated with VCP significantly affects the quality of life of the patient and at times require intervention to prevent aspiration or to improve voice quality.7 In a recent publication from our institute the invesigator found a temporary VCP rate of 11.8%.8

Intra operative nerve monitoring (IONM) is a technique of monitoring the RLN during surgery, to help identification and safe guarding of the nerve during total thyroidectomy as well as central compartment clearance (CCC). This is a well established technique with many centers in the world routinely using monitoring during surgery. There have been 4 RCTs and 2 meta analysis looking at the role of IONM in decreasing RLN palsy after thyroidectomy. The results from the same have been equivocal with 3 of 4 RCTs showing no added benefit in decreasing RLN palsy rates with the use of IONM.9-12 Of the 2 meta analysis, there was a decrease in RLN palsy rates in one of the meta analysis. 13 however the other Meta analysis by Higgins et al showed no improvement in RLN palsy rates with the use of IONM.14 In the meta analysis by Yang et al, published in 2016, there was a 44% (p=ns) decrease in temporary RLN palsy rates in the thyroid cancer cohort. However, the literature on use of IONM is still equivocal in literature. The other issue with available literature on use of IONM is that, most studies have looked at a heterogenous population of patients being operated for benign and malignant disease. Also most patients in the series evaluated have been patients who have undergone surgery for benign multinodular goiters. The extent of RLN dissection in these patients is limited as compared to patients undergoing surgery for thyroid cancers which involve total thyroidectomy and central compartment dissections. There have been no RCTs looking at the role of IONM in preventing RLN palsy in thyroid cancer surgeries. Also none of the RCTs performed have had a formal sample size calculation and robust analysis.

Section B: Aims and Objectives Aim: To assess the role of IONM in thyroid cancer surgery

Primary objective:

• To assess if the use of IONM can decrease the rates of temporary RLN palsy after thyroid cancer surgery

Secondary objectives:

* To assess if the use of IONM can decrease permanent RLN palsy rates in patients with thyroid cancers
* To assess voice parameters in patients with RLN palsy

Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.

Phase III, Assessor Blinded, Randomised Controlled Trial of Use of Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery(ACTION)

The vocal cord mobility of each patient will be documented as mobile, fixed or restricted. Restriction of VC movement will be considered as an event for analysis. Other parameters like phonatory gap, arytenoid position, aspiration evaluation will also be done and recorded.

GRBAS score (Grade of Roughness, Breathiness, Asthenia and Strain)

Tata Memorial Hospital

Professor and Consultant Surgeon Department of Head & Neck Surgery, Tata Memorial Centre Secretary, Data Safety Monitoring Unit

Infections

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Hypertrophy

Spondylitis

Constriction, Pathologic

Spondylarthritis

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spinal Stenosis

Spondylosis

Spinal Curvatures

Spinal Neoplasms

Osteoarthropathy, Primary Hypertrophic

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

Joint Diseases

Pathological Conditions, Anatomical

Hernia

Bone Neoplasms

Genetic Diseases, Inborn

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient.

Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

Autonomic nervous system monitoring

Anna Lintelmann, MPH

Amy Schrecengost, BS

Nilanjana Banerji, MS, PhD

Stanley Skinner, MD

A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.

This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.

Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.

Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency in response to IOMN (intraoperative neuromonitoring) stimulations and recordings, will be recorded.

Stanley Skinner

Neurophysiologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Spinal Motor Evoked Potentials in Brain Surgery	NCT02402075	Brain Tumor Glioma		18 Years -	Heinrich-Heine University, Duesseldorf
Trial on Intraoperative Neuromonitoring (IONM) in Thyroid Cancer Surgery.	NCT04842994	Malignant Neopl...	IONM tube	-	Tata Memorial Hospital
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study	NCT02873182	Intervertebral ... Intervertebral ... Spinal Curvatur... Spinal Stenosis Spondylitis Spondylosis Osteoarthropath... Spinal Neoplasm...	Autonomic nervo...	18 Years - 70 Years	Allina Health System

Spots Global Cancer Trial Database for intraoperative neuromonitoring