Clinical trial NCT05023434: A Study to Measure the Effect of Brain Stimulation on Hand Strength and Function in Patients with Brain Tumors
Official title: The Effect of Intraoperative Cortical Stimulation on Hand Strength and Function During Awake Craniotomies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Tumor
Brain Cancer
Motor Cortex; Lesion
Keywords: Brain Stimulation
Cortex Stimulation
Hand Motor Cortex
Primary Motor Cortex
M1
Resection
Surgery
Healthy Volunteers
Hand Strength
Hand Function
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with a clinical indication for an awake craniotomy with motor mapping.

Brief summary: 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. Additionally, there is a paucity of data to inform how altering DES parameters may effect motor mapping. Here, the investigators seek to demonstrate a feasible, standardized protocol to quantitatively assess hand strength and function and systematically assess several stimulation parameters to improve intraoperative measurements and better understand how cortical stimulation interacts with underlying neural function.


Eligibility criteria: AWAKE CRANIOTOMY COHORT

Inclusion Criteria:

1. Age 18 - 75
2. Ability to understand a written informed consent document, and the willingness to sign it
3. Radiographic evidence of tumor on MRI (i.e. non-enhancing) invading primary motor cortex in the non-dominant hemisphere.
4. Karnofsky performance status (KPS) ≥ 70
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. Free of other illness, in the judgment of the investigator, that may shorten life expectancy
8. Willing and able to participate in all aspects of the study

Exclusion Criteria:

1. Presence of other malignancy not in remission
2. Evidence of bi-hemispheric or widespread tumor involvement
3. Medically high-risk surgical candidate
4. History of recent scalp or systemic infection
5. Presence of other implants or foreign bodies in the head
6. Inability to receive an MRI for any reason
7. Inability to receive cortical stimulation for any reason
8. Presence of implanted cardiac device (such as a pacemaker or defibrillator)

Primary outcomes:
measure: Change in Hand strength - Manual Motor Scale (0-5)
timeFrame: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
measure: Change in Hand strength - Dynamometer grip and pinch strength (Newtons)
timeFrame: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
measure: Chang in Hand function (Velocity)
timeFrame: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
measure: Chang in Hand function (Finger Individuation)
timeFrame: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
measure: Chang in Hand function (Smoothness)
timeFrame: Pre-op, intra-op, 1 week post-op and 3 months post-op; 2 visits 3 weeks apart for healthy volunteers
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References: