Studying the Neuronal Basis of Human Social Cognition
An Integrated Single-neuronal, Population-, Local Network- and Stimulation-based Prefrontal Investigation of Human Social Cognition
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Neurosurgical subjects
Subjects undergoing intracranial neurosurgical procedures
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Participants undergoing clinically planned neurosurgical procedures will undergo single-neuronal recordings as they perform brief behavioral tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
15 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ziv Williams, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2009P000218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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