A Study to Evaluate a Handheld Dynamometer During Awake Craniotomy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 20-004730
About this study
The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of glioma located within or adjacent to the motor cortex.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients ≥ 18 years old.
- WHO grade II, III, IV glioma.
- Single lesion.
- Lesions located within or in close proximity to primary, premotor, supplementary motor areas or corticospinal tracts (Verified by preoperative fMRI and/or DTI).
Exclusion Criteria:
- Patients < 18 years old.
- Tumors other than gliomas & Glioma WHO grade I.
- Patients with cognitive, intellectual or psychiatric impairment that could affect the capacity of following instructions evaluated during preoperative neuropsychological testing.
- Patients who are pregnant.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 12/19/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Kaisorn Chaichana, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available