Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT04745156
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-65 years old
2. Ability to understand a written informed consent document, and the willingness to sign it
3. Radiographic evidence of likely low-grade glioma on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
4. Karnofsky performance status (KPS) ≥ 75
5. Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)
6. Normal or near normal speech (Can consistently name at least 4/5 cards)
7. No medical contraindication to surgery
8. Free of other illness that may shorten life expectancy
Exclusion Criteria:
1. Presence of other malignancy not in remission
2. Evidence of bi-hemispheric or widespread tumor involvement
3. Likely candidate to receive GTR on initial resection
4. Medically high-risk surgical candidate
5. History of recent scalp or systemic infection
6. Presence of other implants or foreign bodies in the head
7. Inability to receive an MRI for any reason
8. Inability to receive cortical stimulation for any reason
9. Coagulation disorders and/or use of anti-thrombotic therapies
10. Platelet count \< 50
11. Diathermy procedures
12. Electroconvulsive Therapy (ECT)
13. Transcranial Magnetic Stimulation (TMS)
14. Presence of implanted cardiac device (such as a pacemaker or defibrillator)
15. Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04745156
Study Brief:
Protocol Section:
NCT04745156