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New treatment option for Brain Tumor
Official title A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients With Brain Tumors
ClinicalTrials.gov ID: NCT05023434
What this study is testing
- What it's testing
- The neurosurgical standard of care for treating a patient with a tumor invading hand primary motor cortex (M1) includes performing a craniotomy with intraoperative direct electrical stimulation (DES) mapping and to resect as much tumor as possible without a resultant permanent neurological deficit. However, the subjective nature of current intraoperative hand motor assessments do not offer a comprehensive understanding of how hand strength and function may be impacted by resection.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- AWAKE CRANIOTOMY COHORT
- Age 18 - 75
- Ability to understand a written informed consent document, and the willingness to sign it
- Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
- Karnofsky performance status (KPS) ≥ 70
You likely can't join if
- Presence of other malignancy not in remission
- Evidence of bi-hemispheric or widespread tumor involvement
- Medically high-risk surgical candidate
- History of recent scalp or systemic infection
- Presence of other implants or foreign bodies in the head
- Inability to receive an MRI for any reason
See the full eligibility criteria
- AWAKE CRANIOTOMY COHORT
- Age 18 - 75
- Ability to understand a written informed consent document, and the willingness to sign it
- Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
- Karnofsky performance status (KPS) ≥ 70
- Normal or near normal motor strength (i.e., at least 3/5 in relevant areas)
- Normal or near normal speech (Can consistently name at least 4/5 cards)
- Free of other illness, in the judgment of the investigator, that may shorten life expectancy
- Willing and able to participate in all aspects of the study
- Presence of other malignancy not in remission
- Evidence of bi-hemispheric or widespread tumor involvement
- Medically high-risk surgical candidate
- History of recent scalp or systemic infection
- Presence of other implants or foreign bodies in the head
- Inability to receive an MRI for any reason
- Inability to receive cortical stimulation for any reason
- Presence of implanted cardiac device (such as a pacemaker or defibrillator)
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.