Investigating Dynamic Interactions in Distributed Cognitive Control Networks

Depression Clinical Trial

Official title:

Investigating Dynamic Interactions in Distributed Cognitive Control Networks

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927974
• Other study ID #: IRB-300010350
• Secondary ID: UAB
• Status: Recruiting
• Start date: March 27, 2023
• Est. completion date: January 1, 2028

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: Jessica N Bentley, MD
• Phone: 2059347170
• Email: jbentley[@]uabmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the brain activity associated with cognitive tasks (thinking, reasoning, remembering) in order to understand how the brain works during certain tasks and to improve treatment for diseases like dementia and attention deficit disorders. Cognitive (thinking) impairment may include poor memory function, poor attention span, or psychiatric disorders (ex: ADD, depression). The investigators are interested in the brain activity related to these issues, and want to investigate changes in brain activity while we record activity from specific areas of the brain. These recordings are in addition to clinical (routine or standard of care) recordings being performed to monitor for seizures and do not impact the clinical care.

Description:

Routine intracranial monitoring (ICM) surgery involves placement of several (10-20) electrodes into the brain through a small opening to a target structure. Participants have been deemed a surgical candidate for this procedure, and detailed discussion of the procedure will occur as part of the surgical consent. The Investigators may place sensors (stickers) to monitor participant's arm/hand movements and brain activity. Sensors may be placed on participant's scalp and/or arms and legs. The Investigators may place a device on participant's wrist or finger to measure position (accelerometer). The Investigators may perform voice recordings, eye movement tracking, and motion capture recordings to obtain measures of how stimulation affects speech and other movements. These are performed without any attachment of devices.

Cognitive tasks: Multiple cognitive tasks may be used and will be decided upon based on the clinical symptoms, exam, or comorbidities. These may include Go/No-go, Simon/Stroop task, Stop-signal task, language tasks, Tower of London, gambling task, maze navigation, choice-reaction time, delay tasks, and attention tasks.

Cortico-cortical evoked potentials and Patterned Stimulation: Stimulus pulses at precise time intervals and or various patterns will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes. This does not require any activity from participant.

Tasks will be administered via computer monitor positioned in front of the you. This will be connected to a recording computer. Participant will respond via keyboard, mouse, or response button.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2028
• Est. primary completion date: March 27, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Eligible for surgery based on multi-disciplinary consensus review

• Have a diagnosis of medically-refractory epilepsy

• A minimum of 18 years of age

• Willingness to participate in the paradigms described in the protocol

Exclusion Criteria:

• Inability to provide full and informed consent

• Age younger than 18

• Are not physically able to participate in study-related activities

• Major medical or surgical complication

Related Conditions & MeSH terms

• ADD
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Depression

Intervention

Diagnostic Test:
• Passive testing
Passive testing includes baseline recordings or behavioral tasks without stimulation. Examples include language tasks, cognitive, and motor tasks. Passive testing typically takes 30-60 minutes and does not require presence of an epileptologist as the tasks are of minimal or no risk.
• Active testing
Active testing includes any study activity in which stimulation occurs. The most frequent paradigm consists of delivering small amounts of electrical stimulation through the implanted grid/strip/depth electrodes. This will be either continuous stimulation or patterned stimulation such as intermittent theta-burst . Stimulation will range between 1-8 mAmp. The duration of these pulses will last between 2-5 seconds. Subjects may be asked to rest quietly or to perform behavioral tasks during stimulation. Since there is a risk of evoking seizure activity with active testing, presence of an epileptologist is required. Active testing will only occur once the PI/staff has communicated with the epileptologist regarding safety, feasibility, and timing of active testing. Active testing will typically take 60-90 minutes and is only performed once patients are back on their anti-seizure medications.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Go/No-go	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Simon/Stroop task	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Stop-signal task	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Language task	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Tower of London	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op Day Post-op through study completion, an average of 7 days.
Primary	Gambling task	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Maze navigation	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Choice-reaction time	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Delay task	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Attention task	Cognitive tasks given will be decided upon based on the clinical symptoms, exam, or comorbidities. Tasks will be administered via computer monitor positioned in front of the subject. This will be connected to a recording computer. Participants will respond via keyboard, mouse, or response button.	Post-op through study completion, an average of 7 days.
Primary	Cortico-cortical evoked potentials	Stimulus pulses at precise time intervals will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes.	Post-op through study completion, an average of 7 days.
Primary	Patterned Stimulation	Stimulus pulses at various patterns will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes.	Post-op through study completion, an average of 7 days.