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

StatusNot Yet Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 years 11 months later Aug 2027 → Aug 2033
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Record History

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  1. Primary completion pushed from Aug 2027 to Aug 2033 Show 4 more changesShow less
    • Start date: Aug 1, 2026 to Aug 1, 2028
    • Study completion pushed from Sep 2027 to Sep 2033
    • Eligibility criteria expanded, about 23 words
    • Study description revised
  2. Start date: Aug 1, 2025 to Aug 1, 2026v7
  3. Primary completion date: Sep 2025 to Aug 2027
    • Start date: Aug 1, 2024 to Aug 1, 2025
    • Study completion date: Sep 2025 to Sep 2027
    v6
  4. Start date: Jun 1, 2023 to Aug 1, 2024
    • Primary endpoints: 5 to 7
    • Study description shortened, about 1,121 words
    v5
  5. Start date: Sep 1, 2022 to Jun 1, 2023v4
Show 2 earlier versionsHide 2 earlier versions
  1. Primary completion date: Jan 2025 to Sep 2025
    • Start date: Jan 2022 to Sep 1, 2022
    • Study completion date: Jul 2025 to Sep 2025
    v3
  2. Study description expanded, about 4 wordsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04745156
Lead Sponsor Medical College of Wisconsin
Conditions
(from sponsor)		 Glioma, Glioma Intracranial, Gliomas Benign, Brain Tumor, Brain Cancer, Motor Cortex; Lesion
Related terms Brain Neoplasms, Glioma
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov