A Study to Evaluate a Handheld Dynamometer During Awake Craniotomy

Overview

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	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Kaisorn Chaichana, M.D.	Closed-enrolling by invitation What is this? (?) "Close" Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.	Contact information: Courtney Graddy M.H.A. Graddy.Courtney@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Kaisorn Chaichana, M.D.

Closed-enrolling by invitation

Contact information:

Courtney Graddy M.H.A.

Graddy.Courtney@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials