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NCT Number: NCT05324579

Studying the Neuronal Basis of Human Social Cognition

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Behavioral testing during neuronal recordings

Behavioral

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

Primary outcomes

  1. Number of neurons displaying changes in activity related to task events

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yoav Kfir, PhD

CONTACT

[email protected]

Ziv Williams, MD

CONTACT

[email protected]

6173126534

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brown University

Registry information

Official study title

An Integrated Single-neuronal, Population-, Local Network- and Stimulation-based Prefrontal Investigation of Human Social Cognition

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 12, 2022
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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