Neoplasms

Symptoms and General Pathology

All Conditions

Rare Diseases

Neoplasm Metastasis

Glioma

Neoplastic Processes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Critical steps of brain mapping and tumor removal will be performed in awake patient

Brain mapping and tumor removal will be performed in asleep patient

Surgeon performs critical steps of tumor removal in awake patient and controls his/her motor functions by brain mapping and assessing of voluntary movements

Tumor resection in awake patient

Surgeon removes tumor in asleep patient and controls his/her motor functions by brain mapping

Tumor resection in asleep patient

Alexander Dmitriev, MD

Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.

Awake surgery is usually used for tumor resection located in language areas. But patient's awakening during removal of mass lesions from motor areas can give additional opportunities. Besides checking of muscle contractions and integrity of motor fibers a surgeon in awake patient can assess planning of movements, praxis, visual feedback and vestibular processing of motions. Preserving of voluntary movements can be an additional proof that cortical motor centers and corticospinal tract were not damaged. At the moment there are no published results of randomized trials showing advantage of awake surgery in removal of mass lesions from motor brain areas.

Objective of the study is to determine whether resection of gliomas and metastases of motor areas using awake surgery can achieve rarer motor deterioration after operation than using general anesthesia.

Participants of the study will be randomly operated using awake surgery or general anesthesia. In both groups intraoperative neuromonitoring will be used. Dynamics of motor functions will be assessed before and after surgery by blinded neurologists.

Dynamics of motor function before, within 10 days after surgery and in 3 months after surgery will be assessed by neurosurgeon blinded for the treatment arm

General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas

General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas: a Randomised, Controlled Trial

Motor function is assessed in Medical Research Council scale and is compared before and after surgery, deterioration of motor function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe disturbance means decline to 9 points or less

Early motor function is assessed in Medical Research Council scale and is compared before and after surgery

Late motor function is assessed in Medical Research Council scale and is compared before and in 3 months after surgery

Speech function is assessed in Hendrix scale (2017) and is compared before and after surgery, deterioration of speech function means decline of 1 grade or more; level of consciousness is assessed in Glasgow Coma scale, it's severe depressing means decline to 9 points or less

Early speech function is assessed in Hendrix scale (2017)

Assesses patients' possibilities to self-service in Karnofsky Performance Status scale

Extent of resection = (preoperative tumor volume - postoperative tumor volume) / preoperative tumor volume x 100

Absence of tumor tissue in postoperative magnetic resonance imaging

Duration of surgery from skin incision till last skin suture

Blood loss from skin incision till last skin suture

How long patient was treated in intensive care unit

How long patient was treated in the hospital from admission till discharge

Which cerebral complications arose after surgery

Which somatic disorders arose after surgery

Whether repeated hospital admissions were required due to postoperative complications

Late speech function is assessed in Hendrix scale (2017)

Assessment of patients' possibilities to self-service in Karnofsky Performance Status scale

Sklifosovsky Institute of Emergency Care

Principal Investigator

Nervous System Diseases

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

This is a device feasibility study, therefore participants will only be enrolled into the investigational arm and will receive the RNS System Implantation.

Following resection consistent with SoC, if there is evidence of residual tumor which cannot be resected due to invasion of hand-M1 but which is small enough to be covered by two four-electrode strips, these strips will be placed on the functional cortex of interest and secured to the dura. The location of the leads will be registered into the navigation software (either Medtronic Stealth or Brainlab). The dura will then be closed as watertight as possible, and the RNS System will be incorporated into the craniotomy on closure Prior to closure, four bone screws will be placed and registered to the intraoperative navigation system as internal fiducials to be retrieved for future procedures.

RNS System Implantation

Sarah Cornell

Max Krucoff, MD

This study uses a cranial implant to deliver cortical stimulation that, when paired with physiotherapy, will remap the brain so that critical brain functions can be protected during brain tumor surgery. This pilot study will provide initial evidence for the safety and feasibility of such a protocol which will lead to future pivotal trials that could radically change eloquent area brain surgery. For patients with otherwise incompletely resectable brain tumors, this could mean a longer life expectancy and a better quality of life.

Study Protocol: Participants will undergo a standard-of-care craniotomy for resection of low-grade glioma. If part of the lesion cannot be removed due to involvement of functional cortex, RNS (Responsive Neurostimulation System \[RNS; NeuroPace, Inc.\]) electrodes will be implanted over the tumor-invaded area(s) in five participants. Stimulation will then be optimized for each individual to disrupt the function of the invaded cortical node (e.g., hand motor area -\> hand dysfunction) (Aim 1). Over the next two months, outpatient physiotherapy will work to overcome the stim-induced deficits through gradual increases in stimulation amplitude as other, non-stimulated brain regions begin to assume its function (Aim 2). Once complete, participants will return to the OR for device explantation, repeated intraoperative mapping, and extended resection (if safe) (Aim 3).

Aim 1: Optimize stimulation to maximize stim-induced deficits and minimize side effects Rationale: To induce plasticity, stimulation parameters must be individually tuned to maximize effect and minimize side effects. Approach: After device implantation and prior to hospital discharge, stimulus settings (frequency, pulse-width, and amplitude) will be optimized to the relevant clinical response while minimizing adverse effects (e.g., focal tonus, myoclonus, or seizures) while still in the safe, inpatient setting. Outcomes: Primary Endpoints: 1) stim-induced focal clinical deficit as measured on the relevant clinical scale (e.g., manual motor score \[0-5\], picture naming \[x/10\]), repetition \[x/3\]); 2) stim-induced side effects (e.g., seizures).

Aim 2: Evaluate extent of remapping and safety of outpatient stimulation-physiotherapy protocol. Rationale: The ability to deliver chronic, outpatient stimulation is vital for practical clinical translation, yet neither its safety nor efficacy has been demonstrated. Approach: After Aim 1, a physiotherapist will assign a personalized, outpatient therapy regimen aimed at overcoming stim-induced deficits. Participants will have daily virtual sessions and return to clinic 2x/week for amplitude increases to re-induce deficits that therapy has overcome. This will continue until stimulation no longer can induce a deficit, suggesting successful functional remapping and enabling a return to the OR for further resection. Outcomes: Primary Endpoints: 1) absence of stim-related ER visits, readmissions, or serious adverse events (safety), 2) changes in intraop stimulation maps from surgery 1 to surgery 2 (induced remapping).

Aim 3: Evaluate ability to extend surgical resections and associated neurological outcomes. Rationale: Any change in functional boundaries will only be useful if it results in a safe, extended resection. Approach: Each surgery will proceed with standard-of-care intraoperative functional mapping techniques and decision making. Neurological examinations will be performed preoperatively, daily while inpatient, then again at 2-weeks and 3-months postoperatively. Extent of resection will be evaluated as 3D residual tumor volume on postoperative MRI. Outcomes: Primary Endpoint: 1) Change in residual tumor volume after second versus first resection, 2) new neurological deficits 3-months after second resection compared to before second resection. Secondary Endpoint: 1) New, temporary neurological deficits after the second surgery

A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas

Inducing Functional Plasticity in Glioma-Involved Functional Cortex With Deficit-Inducing Cortical Stimulation and Targeted Behavioral Therapy to Increase Extent of Resection

Calculated as: Tumor volume after second surgery - tumor volume before second surgery. Determination of volumes will be made by an attending radiologist without knowledge of clinical outcome. Manual segmentation will be performed to measure tumor volumes based on fluid-attenuated inversion recovery (FLAIR) axial slices.

Calculated as manual muscle score (MMS) before stimulation - MMS after stimulation.

MMS is a zero-to-five scale assessed as the following:

5 - normal strength 4 - give away weakness 3 - movement against gravity 2 - movement in anti-gravity position

1 - muscle twitch 0 - no movement

3a. Calculated as picture naming score (x/10) before stimulation minus after stimulation.

3b. Calculated as sentence repitition score (x/3) before stimulation minus after stimulation.

Reported as number of unintended stimulation effects, such as myoclonus, tonus, seizures, or unpleasant sensations

Reported as number of stimulation- or physiotherapy related ER visits, readmissions, or serious adverse events

This outcome will be reported as a descriptive variable, calculated as changes in the intraoperative stimulation map obtained during surgery 2 compared to surgery 1

Any new, permanent neurological deficits resulting from the second surgery

Medical College of Wisconsin

Assistant Professor of Neurological Surgery

Gland and Hormone Related Diseases

Meningioma

Adenoma

Pituitary Diseases

Neurilemmoma

Pituitary Neoplasms

Hypothalamic Diseases

Endocrine System Diseases

Neoplasms, Vascular Tissue

Meningeal Neoplasms

Neuroendocrine Tumors

Neuroma

Nerve Sheath Neoplasms

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Schwannoma

Neuroendocrine Tumor

The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 1998, and who have had MR re-examination after first MR exam because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed primary intracranial neoplasms of CNS WHO grade 2 or lower and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant. It is practically impossible to obtain informed consent from patients of this retrospective cohort, and consent was waived by the Institutional Review Board. Target population of this retrospective cohort is 1,500 tumors.

The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since February 2022, and who have had MR re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed primary intracranial neoplasms of CNS WHO grade 2 or lower and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant. The cohort will consists of patients who agree to participate with written consent. Target population of this prospective cohort is 1,500 tumors.

Chul-Kee Park, MD PhD

Ho Kang, MD

The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had magnetic resonance (MR) re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. In all MRs taken by patients, the date of imaging and the volume of the tumor are measured, and we aim to establish a natural growth history for non-malignant brain tumors.

Non-malignant central nervous system (CNS) tumor accounts for 70% of all primary CNS tumors, and over 300,000 patients were diagnosed with non-malignant CNS tumor per year in the United States. Not much is known about the natural history of non-malignant CNS tumors, as it is often treated immediately upon detection. However, some of them, especially small and asymptomatic non-malignant CNS tumors should not be treated immediately upon diagnosis but are observed and followed-up by repeated magnetic resonance imaging (MRI). This study aims to make a prospective cohort of non-malignant CNS tumors that do not require immediate treatment and to quantitatively analyze which factors are related to the growth of tumors.

The registry of this study was subjected to patients who were radiologically diagnosed with a non-malignant brain tumor at Seoul National University Hospital since 2001, and who have had MR re-examination after first MR exam or will be re-examined because it was determined that immediate treatment would not be needed at the first visit to the hospital. Non-malignant brain tumors are defined as radiologically diagnosed neoplasms of CNS WHO grade 2 or lower among primary intracranial tumors and include meningioma, schwannoma, pituitary adenoma, and glioma suspected to be non-malignant.

SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)

The Risk of Growth in Patients With Non-malignant Brain Tumor: SeOuL cOhort of Brain Tumor MONitoring (SOLOMON) Study

We have no plan to share our individual participant data because is is not permitted by the Institutional Review Board.

T2 signal intensity of tumor as a ratio to contralateral white matter

Percentage of tumors that change on average per year

Number of patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.

Pre-treatment follow-up period for patients who eventually received treatment, such as surgery, radiosurgery, radiotherapy, or hormonal therapy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	NCT05485038	Gliomas Benign Glioma, Maligna... Metastases to B...	Tumor resection... Tumor resection...	18 Years - 69 Years	Sklifosovsky Institute of Emergency Care
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	NCT05485038	Gliomas Benign Glioma, Maligna... Metastases to B...	Tumor resection... Tumor resection...	18 Years - 69 Years	Sklifosovsky Institute of Emergency Care
A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas	NCT04745156	Glioma Glioma Intracra... Gliomas Benign Brain Tumor Brain Cancer Motor Cortex; L...	RNS System Impl...	18 Years - 65 Years	Medical College of Wisconsin
General Anesthesia Versus Awake Surgery in Resection of Gliomas and Metastases of Motor Areas	NCT05485038	Gliomas Benign Glioma, Maligna... Metastases to B...	Tumor resection... Tumor resection...	18 Years - 69 Years	Sklifosovsky Institute of Emergency Care
SeOuL cOhort of Brain Tumor MONitoring Study (SOLOMON)	NCT05254197	Brain Tumor, Pr... Meningioma Schwannoma Pituitary Adeno... Gliomas Benign		18 Years -	Seoul National University Hospital

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