Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2022-05-20
2026-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Neurosurgical subjects
Subjects undergoing intracranial neurosurgical procedures
Behavioral testing during neuronal recordings
Participants undergoing clinically planned neurosurgical procedures will undergo single-neuronal recordings as they perform brief behavioral tasks.
Interventions
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Behavioral testing during neuronal recordings
Participants undergoing clinically planned neurosurgical procedures will undergo single-neuronal recordings as they perform brief behavioral tasks.
Eligibility Criteria
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Inclusion Criteria
2. patients able to give informed consent
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
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Brown University
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Ziv Williams, MD
Associate Professor
Principal Investigators
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Ziv Williams, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Ziv Williams, MD
Role: primary
Yoav Kfir, PhD
Role: backup
Wael Asaad, MD
Role: primary
Other Identifiers
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2009P000218
Identifier Type: -
Identifier Source: org_study_id