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Hand-held Dynamometer for Brain Tumor
N/A
Recruiting
Led By Kaisorn Chaichana, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Primary or Recurrent Brain tumors
Patients ≥ 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights
Study Summary
This trial will study if it's safe and reliable to use a handheld device to measure a person's motor function during awake brain surgery.
Who is the study for?
This trial is for adults over 18 with primary or recurrent brain tumors. Participants must have a single brain lesion near the motor cortex, confirmed by preoperative imaging. It's not suitable for those under 18, with serious health issues like heart failure or severe lung disease, or cognitive impairments affecting instruction following.Check my eligibility
What is being tested?
The study tests the use of a handheld dynamometer to measure muscle strength during awake craniotomy in patients having surgery to remove brain lesions close to areas controlling movement.See study design
What are the potential side effects?
Since this trial involves monitoring with a device rather than testing a drug, there are no direct side effects from medication. However, risks may include discomfort from using the dynamometer and potential interference with surgical procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have a primary or recurring brain tumor.
Select...
You are 18 years old or older.
Select...
You have only one lesion in your brain.
Select...
The lesion is located in or next to the part of the brain that controls movement.
Select...
The tumor is in an area of the brain that controls movement.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intraoperative maximum grip strength (KgF) baseline
Intraoperative maximum grip strength (KgF) variability
Maximum grip strength (KgF) variability from preoperative baseline
+1 moreSecondary outcome measures
Correlation Coefficient (ρ) between hand-held dynamometry and manual motor testing during AC
Postoperative Maximum Grip Strength (KgF)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an ACExperimental Treatment1 Intervention
5 patient minimum
Group II: Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)Experimental Treatment1 Intervention
5 patient minimum
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,460 Total Patients Enrolled
Kaisorn Chaichana, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a primary or recurring brain tumor.You have serious health issues like heart failure, severe lung disease, extreme obesity, or sleep apnea.You have a condition that may make it hard for you to understand and follow instructions.You are 18 years old or older.You have only one lesion in your brain.The lesion is located in or next to the part of the brain that controls movement.The tumor is in an area of the brain that controls movement.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1. Patients with brain lesions in non-motor areas undergoing an awake craniotomy (AC)
- Group 2: Cohort 2. Patients with brain lesions within or proximal to motor areas undergoing an AC
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the research team currently seeking participants for this trial?
"According to the clinicaltrials.gov website, this medical trial is actively enrolling participants and was first posted on July 1st 2020 with its last update occurring on December 21st 2021."
Answered by AI
How many participants will be taken into this clinical experiment?
"Affirmative. The clinical trial is actively enrolling participants, according to its record on clinicaltrials.gov which was first posted in July of 2020 and updated December 21st 2021. To date the study has recruited 10 individuals at one site."
Answered by AI
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