Studying the Neuronal Basis of Human Social Cognition

NCT05324579 | Recruiting

• 1 other identifier: 2009P000218
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Neurosciences

Outcome Measures

Primary Outcomes (1)

• Number of neurons displaying changes in activity related to task events

  Neuronal signals will be recorded during performance of a language-based social task over a 15 minute period. A multinomial logistic regression analyses will be used to evaluate for changes in neuronal activity that are associated with social versus non-social task events. Neuronal activity will be measured as the number of spikes recorded during each event, with each event lasting for approximately one second. Significance threshold will be set to p \< 0.01. The primary outcome measure will be the proportion of neurons that reach significance threshold and therefore display task-related modulation.

  15 minutes

Secondary Outcomes (1)

• Percentage of task events that can be correctly predicted from neuronal activity

  15 minutes

Study Arms (1)

Neurosurgical subjects

EXPERIMENTAL

Subjects undergoing intracranial neurosurgical procedures

Behavioral: Behavioral testing during neuronal recordings

Interventions

Behavioral testing during neuronal recordings BEHAVIORAL

Participants undergoing clinically planned neurosurgical procedures will undergo single-neuronal recordings as they perform brief behavioral tasks.

Neurosurgical subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or older
• patients able to give informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brown University: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

NOT YET RECRUITING

Study Officials

• Ziv Williams, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziv Williams, MD

CONTACT

6173126534; zwilliams@mgh.harvard.edu

Yoav Kfir, PhD

CONTACT

ykfir@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Human subjects undergoing clinically planned neurosurgical procedures

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: April 12, 2022
• Study Start: May 20, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: Processed neural data and relevant code will be made publicly available at the end of the study

Locations

US (2)