Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05374551
Other study ID # R01MH125990
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 6, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Boston College
Contact Maureen Ritchey, PhD
Phone 617-552-4779
Email maureen.ritchey@bc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to understand the basic brain mechanisms supporting episodic memory in healthy young adults. Transcranial magnetic stimulation will be used to influence brain activity in regions thought to be important for episodic memory. Behavioral testing and MRI will be used to measure the effects of stimulation on memory and on changes in brain network interactions, allowing us to draw causal inferences regarding the role of specific brain regions in memory processes.


Description:

In this study, healthy young adult participants will complete three sessions: an MRI session for collecting structural and functional brain images and two sessions including transcranial magnetic stimulation followed by MRI. In one stimulation condition, stimulation will target a brain region of experimental interest (lateral parietal cortex) and in the other, stimulation will target a control brain region (vertex). Both stimulation conditions will be followed by MRI scans and a memory task. All participants will complete all experimental conditions. The order of stimulation conditions will be counterbalanced across subjects. Trials in the memory task will be randomized separately for each participant. Thus, each participant will experience the same number of sessions and trials in each condition, but their experiences will be different due to counterbalancing and randomization. Randomization and counterbalancing of trial conditions will occur before participants are recruited, thus these aspects of the study design are predetermined before participant involvement. Data analysis will be based on within subject effects of stimulation on behavioral measures of memory performance and neural measures of functional connectivity in key regions of interest.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Ages 18 to 35 years old - Fluent in English - Free of major neurological or psychiatric illness - Right-handed - Normal or corrected to normal vision Exclusion Criteria: - History of a psychiatric illness within the past two years - History of a learning disorder (e.g., attention deficit disorder, dyslexia) - History of neurological disorder or brain injury, including family history of epilepsy, convulsions or seizures, stroke; vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, even without a history of seizure, and without anticonvulsant medication, and any unexplained lifetime loss of consciousness/syncope - Use of medications that reduce seizure threshold (e.g., tricyclic antidepressants, neuroleptic agents) - History of neurosurgery - History of heart disease - Recreational drug use in the past two months - Uncontrollable shaking, or inability to sit/lie still for one hour - Evidence of neurological disorders or structural abnormalities, based on MRI - Pregnancy - Prior surgeries, conditions, and/or implants that are not MRI-safe, including: pacemaker, pacemaker wires, artificial heart valve, brain aneurysm surgery, middle ear implant, non-removable hearing aids, braces, or extensive dental work, implanted mechanical or electrical device, artificial limb or joint - Foreign metallic objects in the body, such as bullets, BBs, shrapnel, or metalwork fragments - History of metal work or ocular metallic foreign bodies - History of uncontrolled migraines or susceptibility to headaches - Use of centrally-acting medications and drugs, with the exception of caffeine, within the last 12 hours - Concurrent treatment with ototoxic medications - Current sleep deprivation, extreme fatigue, or recent jet lag - Claustrophobia - Pre-existing noise induced hearing loss - Any prior adverse experience (e.g. physical or psychological discomfort) with repetitive TMS or MRI scanning

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Transcranial magnetic stimulation
Transcranial magnetic stimulation will be used to stimulate brain activity in a brain region of experimental interest (lateral parietal cortex) and in a control brain region (vertex). All participants will experience both forms of stimulation, in separate sessions. Stimulation will be applied as a probe to understand the basic phenomenon of how brain processes support episodic memory.

Locations

Country Name City State
United States Boston College Chestnut Hill Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Boston College

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy on tests of episodic memory Participants will complete tasks where they encode and retrieve events. Episodic memory quality will be assessed as the accuracy with which they can recall scene details associated with each event. Tasks will be completed during the hour following stimulation.
Primary Task-related functional connectivity among posterior medial brain regions Psychophysiological interaction analyses will be used to assess task-related functional connectivity while participants complete the memory retrieval task. This will identify interactions among brain regions that are associated with successful memory retrieval. Functional connectivity will be assessed during the hour following stimulation.
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1