Studying the Neuronal Basis of Human Social Cognition

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324579
Collaborator
Brown University (Other)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral testing during neuronal recordings
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Human subjects undergoing clinically planned neurosurgical proceduresHuman subjects undergoing clinically planned neurosurgical procedures
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
An Integrated Single-neuronal, Population-, Local Network- and Stimulation-based Prefrontal Investigation of Human Social Cognition
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Apr 1, 2026
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Neurosurgical subjects

Subjects undergoing intracranial neurosurgical procedures

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

Outcome Measures

Primary Outcome Measures

  1. Number of neurons displaying changes in activity related to task events [15 minutes]

    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.

Secondary Outcome Measures

  1. Percentage of task events that can be correctly predicted from neuronal activity [15 minutes]

    Neuronal signals will be recorded during performance of a language-based social task over a 15 minute period. Support vector machines will be used to determine whether changes neuronal activity can accurately predict the participants task performance. Neuronal activity will be measured as the number of spikes recorded during each question-answer 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 percentage of events that are predicted correctly.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114
2 Rhode Island Hospital Providence Rhode Island United States 02903

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Brown University

Investigators

  • Principal Investigator: Ziv Williams, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ziv Williams, MD, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05324579
Other Study ID Numbers:
  • 2009P000218
First Posted:
Apr 12, 2022
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 25, 2022