In-depth Investigation of Brain Network Interactions

NCT04748146 | Withdrawn

• 1 other identifier: STU00213066
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Brain stimulation is a means to potentially remediate symptoms in a range of neurological and psychiatric diseases, however, precise targeting of stimulation is necessary to ensure efficacy. The proposed project will use recent advances in functional magnetic resonance imaging to delineate distributed brain networks within individuals, and use these network maps to guide selection of intracranial electrodes for stimulation during an episodic memory task. The resulting data will refine the current understanding of the neural systems involved in episodic memory, and provide a proof-of-principle for the use of individual-level network mapping to guide brain stimulation, which could have important implications for brain stimulation therapies for a range of mental health disorders.

Conditions

Episodic Memory

Keywords

Episodic Memory; Default Network; Brain Stimulation

Outcome Measures

Primary Outcomes (2)

• Reaction Time

  Reaction time for cued episodic recollection task

  Immediate during procedure

• Accuracy

  Number of correct responses in cued episodic recollection task

  Immediate during procedure

Study Arms (1)

Intervention and Control group

OTHER

Each patient will receive electrical and sham stimulation, meaning that each patient will act as their own control.

Other: Brain stimulation

Interventions

Brain stimulation OTHER

Theta-burst stimulation will be applied to selected regions of distributed networks to test whether distal stimulation can modulate hippocampus-mediated episodic recollection.

Intervention and Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Participants will be inpatients of the Northwestern Memorial Hospital Comprehensive Epilepsy Center undergoing intracranial electroencephalography for presurgical planning as part of their routine care for epilepsy. Participants will be recruited to participate in the study if their epilepsy monitoring procedures will include placement of recording electrodes at locations of interest to our study, which include the medial temporal lobe, frontal cortex, parietal cortex, and temporal cortex. The decision regarding where to place electrodes is made for purely clinical purposes and we recruit patients with locations that are relevant to our research question as a convenience sample. We will exclude children under the age of 18 years as brain development is still occurring in children under the age of 18 years relative to adults. Furthermore, children rarely receive iEEG for epilepsy and therefore would not be available to recruit into the study. Special populations listed below will not participate in this study. Excluded populations include: 1. Adults legally unable to provide informed consent 2. Individuals who are not yet adults (children below the age of 18) 3. Pregnant women 4. Prisoners To help determine eligibility for the MRI portion of the study, a safety questionnaire will be administered by research staff prior to receiving an MRI. Answers to these questions are used to determine whether subjects meet any of the exclusionary criteria listed next. Exclusions for MRI include standard MRI contraindications, including claustrophobia, metal implants or fragments in the body, and actual or potential pregnancy.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (17)

• Tulving, E. (1983) Elements of episodic memory. Oxford. Clarendon Press ; New York : Oxford University Press. xi, 351 p. p.

  BACKGROUND

• Dickerson BC, Eichenbaum H. The episodic memory system: neurocircuitry and disorders. Neuropsychopharmacology. 2010 Jan;35(1):86-104. doi: 10.1038/npp.2009.126.

  PMID: 19776728 BACKGROUND

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  PMID: 18400922 BACKGROUND

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  PMID: 26212711 BACKGROUND

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  PMID: 28728026 BACKGROUND

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  PMID: 21282630 BACKGROUND

• DiNicola LM, Braga RM, Buckner RL. Parallel distributed networks dissociate episodic and social functions within the individual. J Neurophysiol. 2020 Mar 1;123(3):1144-1179. doi: 10.1152/jn.00529.2019. Epub 2020 Feb 12.

  PMID: 32049593 BACKGROUND

• Foster BL, Kaveh A, Dastjerdi M, Miller KJ, Parvizi J. Human retrosplenial cortex displays transient theta phase locking with medial temporal cortex prior to activation during autobiographical memory retrieval. J Neurosci. 2013 Jun 19;33(25):10439-46. doi: 10.1523/JNEUROSCI.0513-13.2013.

  PMID: 23785155 BACKGROUND

• Foster BL, Parvizi J. Direct cortical stimulation of human posteromedial cortex. Neurology. 2017 Feb 14;88(7):685-691. doi: 10.1212/WNL.0000000000003607. Epub 2017 Jan 18.

  PMID: 28100728 BACKGROUND

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• Parvizi J, Kastner S. Promises and limitations of human intracranial electroencephalography. Nat Neurosci. 2018 Apr;21(4):474-483. doi: 10.1038/s41593-018-0108-2. Epub 2018 Mar 5.

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• Suthana N, Haneef Z, Stern J, Mukamel R, Behnke E, Knowlton B, Fried I. Memory enhancement and deep-brain stimulation of the entorhinal area. N Engl J Med. 2012 Feb 9;366(6):502-10. doi: 10.1056/NEJMoa1107212.

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• Wang L, Saalmann YB, Pinsk MA, Arcaro MJ, Kastner S. Electrophysiological low-frequency coherence and cross-frequency coupling contribute to BOLD connectivity. Neuron. 2012 Dec 6;76(5):1010-20. doi: 10.1016/j.neuron.2012.09.033.

  PMID: 23217748 BACKGROUND

MeSH Terms

Interventions

Deep Brain Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Rodrigo M Braga, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will receive theta-burst stimulation and sham stimulation, meaning that each participant will be their own control.

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: February 10, 2021
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

US (1)