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RecruitingNCT05565118Updated Aug 6, 2026

Prospective Surgical Study on the Pattern of Electrical Activity in High Grade Glioma as a Predictor of Progression

A Phase 1 interventional study of Standard Surgical Treatment and Intraoperative Electrocorticography in High Grade Glioma and Glioblastoma, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Case Comprehensive Cancer Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to test the safety and feasibility of recording brain activity within and around high-grade glioma tumors at the time of surgery. A small biopsy will be taken at the sites of the recordings.

Read the detailed description

High-grade gliomas are incurable primary brain tumors. Recent data support that glioma cells can integrate within neuronal circuits. Glioma cells and neurons communicate via electrical impulses and chemically, through neurotransmitters. This crosstalk has been shown to promote glioma cell migration and invasion in preclinical models. However, the nature of the electrical activity and underlying molecular mechanisms are poorly understood. The long-term goal of this study is to determine the impact of high electrical activity and pattern of activity on tumor invasion, and mechanistic basis of its regulation and functional consequences. This phase I safety and feasibility study is being proposed as a first step toward dissecting the connection between electrical activity and glioma behavior. The goal is to determine the safety and feasibility of recording electrical activity in the tumor-neuron interface using technologies that are already being used clinically for participants undergoing brain surgery.

02

Conditions studied

  • High Grade Glioma
  • Glioblastoma

Keywords

  • High Grade Glioma
  • Glioblastoma
  • Neural Recording
  • Electrical Activity
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's planned enrollment of 10 is below the median of 32 across 1,065 interventional studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.

Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants who have the appearance of high-grade glioma (HGG, WHO Grade 3 and 4, including GBM) on MR imaging are allowed to consent and will undergo the procedure if the frozen is consistent with HGG

OR

  • Participants with a history of histologically-confirmed diagnosis of high- grade glioma that are undergoing resection of a recurrent/progressive tumor that is likely recurrent/progressive high- grade glioma as identified on preoperative MR imaging
  • Age ≥ 18 years old
  • Volumetric MRI within 1 month prior to surgery
  • Karnofsky performance status of 60 or higher
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Participants must be considered appropriate neurosurgical candidates with the following screening/baseline laboratory values within 1 month prior to surgery:

    • Absolute neutrophil count ≥ 1500/µL
    • Platelets ≥ 100 000/µL
    • International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) ≤1.5 × Upper limit of normal (ULN) unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
    • Urine or Serum Pregnancy Test = Negative (Not applicable to participants with bilateral oophorectomy and/or hysterectomy or to those participants who are postmenopausal).

Exclusion criteria

Exclusion Criteria:

  • Severe co-morbidity that would confer excess risk of surgery as determined by the treating physician.
  • Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
  • Is pregnant
  • Coagulopathy or platelet dysfunction that increases the risk of intra and postoperative hemorrhage
  • Tumor location requiring DE placement/biopsy in eloquent or critical region of the brain (e.g. primary motor and sensory cortices, speech and vision centers, thalamus, basal ganglia, cerebellum, brain stem) as deemed by the neurosurgeon designing the surgical plan
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Standard Surgical Treatment + Intraoperative Electrocorticography

    Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology. During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.

    Procedure: Standard Surgical Treatment · Procedure: Intraoperative Electrocorticography

Interventions

  • ProcedureStandard Surgical Treatment

    During this surgery, participants will also undergo a tissue biopsy at recording sites for correlation to neural recording data.

  • ProcedureIntraoperative Electrocorticography

    Each participant will undergo intraoperative electrocorticography (ECOG) through subdural grid (SDG) and depth electrode (DE) via FDA-cleared, standardized, brain recording technology.

06

What researchers measure

Primary outcomes

  1. Correlation between electrical activity and anatomic region of progression based on follow-up contrast-enhanced MRI

    To describe the pattern of electrical activity (neuronal hyperexcitability) in brain surrounding the enhancing tumor during open surgery in patients with high grade gliomas and its correlation with progression

    Time frame: Up to 9 months post surgery

Other outcomes

  1. Correlation between electrical activity (neuronal hyperexcitability) in brain surrounding the enhancing tumor and cellular and molecular profile of the tumor and its microenvironment

    Electrical activity will be assessed as described above and correlated with transcriptomic changes. Bioinformatics analyses including gene ontology analyses and multi-dimensional network analyses will be performed.

    Time frame: At study completion, an aim for 1 year post treatment

07

Study locations

1 of 1 sites recruiting
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Aggregate data will be shared, while individual data will not need to be shared.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05565118
Lead sponsor
Case Comprehensive Cancer Center
Collaborators
Burkhardt Brain Tumor and Neuro-Oncology Center
Responsible party
Sponsor
First posted
Oct 4, 2022
Start date
Apr 9, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 6, 2026

Study contacts

Jennifer Yu, MD, PhD
Contact
taussigresearch@ccf.org
1-866-223-8100
Jennifer Yu, MD, PhD
principal investigator · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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