Electrocorticography in Mapping Functional Brain Areas During Surgery in Patients With Brain Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This pilot clinical trial studies how well electrocorticography works in mapping functional brain areas during surgery in patients with brain tumors. Using a larger than the standard mapping grid currently used during brain tumor surgery or a high-definition grid for electrocorticogram brain mapping may help doctors to better identify which areas of the brain are active during specific limb movement and speech during surgery in patients with brain tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing a tumor resection at the University of Texas M. D. Anderson Cancer Center for a newly diagnosed as well as recurrent primary or metastatic brain tumor located in or adjacent to motor and/or speech brain areas
Patients >= 18 years of age
Signed informed consent
Disqualifiers
Patients with significant neurological motor deficits of the upper extremities, and/or speech deficits, which would preclude them from performing the while awake intra-operative tasks at the discretion of the principal investigator (PI)
Patients who have impaired vision and/or hearing and whose performance could affect the study will be excluded at the discretion of the PI
Trial design
Design model
Single group
Treatments tested in this trial
Direct Electrocortical Stimulation
Procedure/SurgeryUndergo direct electrocortical stimulation
Electrocorticography
Other interventionUndergo electrocorticography
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Diagnostic (electrocorticography)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Electrocorticogram (ECoG)
Will be assessed by cortical electrical activity based on individual hand muscle function. ECoG will be compared to direct electrical stimulation (DES), navigated transcranial magnetic stimulation (nTMS), and functional magnetic resonance imaging (fMRI). The data obtained using ECoG will be correlated with the fMRI and TMS data acquired preoperatively and intraoperative DES. The categorical variables would be preoperative Karnofsky performance status and functional status, tumor location, fMRI, TMS, ECoG, and DES data points. Other variables involved in the analysis would be extent of resection and neurological and language/speech outcome. The Chi-square or Fisher's exact tests will be used to explore associations between categorical variables. Additional analysis may be performed.
Time frame
Up to 6 months (± 4 weeks)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
University of Houston
Collaborator
Source ClinicalTrials.gov