In this arm, trial participants receive the intervention that is being tested, skullremodeling surgery. This is in combination with tumor treating fields and best practice medical treatment.

In this arm, the trial participant receives tumor treating fields and best practice medical treatment.
This serves as an active comparative control arm to the intervention.

Recurrent Glioblastoma

Strategically placed cranial burrholes in order to improve the TTField "dose" focally in the tumor.

Skullremodeling surgery

Tumor treating fields combined with best medical treatment.

Control

Aarhus University Hospital

Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)

Enhancing Tumor Treating Fields for Recurrent Glioblastoma With Targeted and Individualised Skullremodeling Surgery: A Multi-center Randomized Phase 2 Trial

Overall objective response rate assessed by modified RANO criteria

Standardised and verified questions related to quality of life to cancer and brain tumor patients. Quality of life is rated by the patients own thoughts about the current situation and future and also the presence or absence of the most common symptoms in cancer and brain tumors. Rated from a scale 1-4 (none to a lot) and 1-7 scale (very poor to very good).

Adverse events / Safety. All adverse events observed by personnel or reported by trial participant.

All data published will be available upon request. Study protocol will be published.

Anders Rosendal Korshøj

Principal Investigator, Associate Professor

NovoCure GmbH

Odense University Hospital

Patients will be randomized 1:1 to one of two study arms to receive either, 1) skullremodeling-surgery, TTFields and best practice medical oncological therapy (interventional arm), or 2) TTFields and best practice medical oncological therapy alone (control arm).

Skullremodeling surgery prevents the participant, careprovider and investigator to be blinded to the randomization.
The outcome assessors (statisticians) will be blinded when analysing the data.

Low-Intensity Focused Ultrasound Pulsation (LIFUP) sonications will be conducted using the LIFUP experimental device BX Pulsar 1002 produced by the Brainsonix Corporation. For the purposes of safety LIFUP sonications will be initiated at the FDA limit for diagnostic ultrasound. However, the minimally effective dose in humans applications, according to (Lee et al., 2015), when derated is approximately 1125mW/cm2.

Low Intensity Ultrasound Pulsarions

LIFUP will be administered to the temporal region on the side to undergo surgery, within the focus producing seizures. The ultrasound will be focused on the highest activity area within the temporal lobe. Functional MRI of the brain will be obtained throughout the LIFUP session.
After the participant is fitted with the transducer they will be placed in the MRI machine and undergo a series of scans. After placing the transducer over the anterior tip of the temporal lobe the participant will undergo fMRI BOLD scans with LIFUP excitation (from (Lee et al., 2015): Tone Burst Duration = 2ms and Pulse Repetition Frequency = 250Hz) at four levels of intensity (720mW/cm2, 1440mW/cm2, 2880mW/cm2 and 5760mW/cm2). Before increasing the intensity, the transducer will be moved approximately 5mm posterior. After the last excitation scan the LIFUP parameters will be changed to inhibitory parameters (from (Yoo et al., 2011): Tone Burst Duration = 0.5ms and Pulse Repetition Frequency = 100Hz).

BX Pulsar 1002

Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy

Change in BOLD signal during or after LIFUP sonication

Darin Dougherty

Director, Division of Neurotherapeutics, Department of Psychiatry

Massachusetts General Hospital

Participants will be recruited from the normal population of patients being treated for temporal lobe epilepsy Massachusetts General Hospital.
Patients identified as candidates for temporal lobe surgery by the clinical team will be notified via a letter that has been signed by a physician representative of the practice of their eligibility for the study. An administrator will follow-up on the letter with a phone call. The physician of potential participants will be notified of their eligibility for the study, and be provided with a copy of the consent form. A total of 3 participants will be enrolled in the project.

2 mA of cathodal tDCS placed over M1 for 20 mins

0 mA of sham tDCS placed over M1 for 20 mins

2 mA of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex

Active tDCS

0 mA of sham tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex

Sham tDCS

Total

Sex: Female, Male

Etiologies of epilepsy

Baseline seizure frequency per day

Baseline epileptic discharges per 30 minutes

Age at onset of seizures

Number of antiepileptic drugs used

Number of Seizure After Treatment by tDCS

Number of Epileptic Discharge After Treatment by tDCS

2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins
tDCS: brain stimulation by cathodal electrode at motor cortex

Overall Study

Paradee Auvichayapat

Lennox-Gastaut Syndrome

brain stimulation by cathodal electrode at motor cortex

tDCS

Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study

Transcranial Direct Current Stimulation for Treatment of Childhood Pharmacoresistant Lennox-Gastaut Syndrome, A Pilot Study

Head of Noninvasive Brain Stimulation Research Group of Thailand, Department of Physiology; Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand.

Khon Kaen University

Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed.

Stroke

Hemiparesis

Anatomical and Diffusion Tensor Imaging Analysis.

Magnetic Resonance Imaging

Assessment of brain (cortical) excitability

Transcranial Magnetic Stimulation

Spontaneous movement assessment of infant while lying in unperturbed state.

General Movement Assessment

University of Minnesota

Perinatal Stroke: Understanding Brain Reorganization

Perinatal Stroke: Understanding Brain Reorganization Through Infant Neuroimaging and Neuromodulation

TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimate time of TMS assessment is around 2 hours during Visit 2.

Magnetic resonance imaging (MRI)/diffusion tensor imaging (DTI) will be performed when infants are sleeping with a real scanning time of 38 minutes during visit 1.

The movement quality will be assessed by general movement assessment (GMA). GMA requires 5-10 minutes video taping when infants are placed in spine position for scoring.

Assessment of vital signs changes and pain/stress responses during both MRI and TMS assessment during visit 1 and visit 2.

arnold-chiari malformation/epileptische aanval

Improving Tumor Treating Fields Treatment for Brain Cancer Patients With Skullremodeling Surgery (Neurosurgery)

Focused Ultrasound Neuromodulation for Treatment of Temporal Lobe Epilepsy

Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study

Perinatal Stroke: Understanding Brain Reorganization

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