Clinical trial NCT05324579: Studying the Neuronal Basis of Human Social Cognition
Official title: An Integrated Single-neuronal, Population-, Local Network- and Stimulation-based Prefrontal Investigation of Human Social Cognition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurosciences
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
First posted: 2022-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Human subjects undergoing clinically planned neurosurgical procedures
Primary purpose: BASIC_SCIENCE

Brief summary: This proposal aims to study the role that the dorsal prefrontal cortex plays in human social cognition.

Detailed description: Despite ongoing progress in the understanding of social behavior, little is known about the single-neuronal mechanisms that underlie human social cognition. The investigators will obtain single-neuronal recordings from the prefrontal cortex in participants undergoing clinically planned deep brain stimulation (DBS) electrode placement.

The study population will consist of subjects undergoing planned DBS placement. Prospective participants will be selected for surgery irrespective of their participation in the study. After consenting to the study, the participants will be allowed to withdraw from participation at any time. No control subjects will be used. Instead, each subject will act as their own control based on task performance.

For the study, neuronal recordings will be integrated within planned neurosurgical care and will be obtained from the prefrontal cortex as participants perform a brief behavioral task. During recordings and prior DBS placement, the participants are normally asked to make movements or answer questions based on verbal cues to aid in targeting the correct areas. The participants will be additionally asked to perform a brief linguistic-based task in which scenarios containing social agents are presented to the participants and in which they have to verbally describe/answer questions about them. Following cortical recordings and stimulation, the standard clinical procedure and DBS electrode placement proceeds as planned. The neuronal and behavioral data will then be analyzed off-line.

Eligibility criteria: Inclusion Criteria:

1. 18 years old or older
2. patients able to give informed consent

Exclusion Criteria:

1. Children under 18
2. Significant co-morbidities
3. Claustrophobia or general anxiety that may impact intraoperative testing
4. Use of CNS-active medications including stimulants and antipsychotics which may alter
5. Pregnancy
6. Operative events that will require expedition of the surgery.
7. Poor tolerance of testing by the patient
8. Increased abnormal cortical excitability
9. Necessity to administer drugs that will interfere with mapping

Primary outcomes:
measure: Number of neurons displaying changes in activity related to task events
timeFrame: 15 minutes
Secondary outcomes:
measure: Percentage of task events that can be correctly predicted from neuronal activity
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Massachusetts General Hospital
name: Ziv Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: