rTMS Brain Stimulation and Cognition

NCT04244682 | Withdrawn FDA Device

• 1 other identifier: IRB00115488
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will use repetitive transcranial magnetic stimulation (rTMS) (a way to use a powerful magnet to cause temporary impairment to the function of a brain region) to test whether certain parts of the brain are necessary to various aspects of memory and emotion. Participation will require up to three visits. One visit will take up to an hour, and the other visits will each take up to three hours each. During the first visit, participants will be consented, and their brains will be scanned using magnetic resonance imaging.

Conditions

Episodic Memory Retrieval

Keywords

Imaging; Neuroanatomy; Magnetic Resonance Imaging (MRI); Neuroscience

Outcome Measures

Primary Outcomes (3)

• Change in Remember/Familiar Scale Score

  Memory accuracy will be assessed using a remember/familiar scale that was created for this study, based on common scales used in basic memory research. This instrument is a a 3-option categorical forced-choice self-report measure that assesses the accuracy of a participant's memory for an item. This measure assesses whether the participant has no conscious memory of the item (New), whether they have a specific conscious recollection of having seen the item before (Remember), or whether they have a conscious sense of having seen the item before but they cannot recollect any specific details relating to the item (Familiar). This scale will be scored by calculating the number of Hits (old items endorsed as remembered/familiar), Misses (old items endorsed as new), Correct Rejections (new items endorsed as new), and False Alarms (new items endorsed as familiar/remembered), and then calculating a sensitivity index (d') for each participant.

  Day 1 (first rTMS visit), Up to Day 14 (second rTMS visit)

• Change in Confidence Scale Score

  Memory confidence will be assessed using a confidence scale that was created for this study, based on common scales used in basic memory research. The confidence scale is a 4-point ordinal forced-choice self-report measure that assess the subjective confidence a participant feels in their memory for an item. The scale's choices are 1 = Little Confidence, 2 = Some Confidence, 3 = Moderate Confidence, and 4 = High Confidence. The scale's responses will be averaged for each participant.

  Day 1 (first rTMS visit), Up to Day 14 (second rTMS visit)

• Change in Vividness Scale Score

  Memory vividness will be assessed using a vividness scale that was created for this study, based on common scales used in basic memory research. The vividness scale is a 4-point ordinal forced-choice self-report measure that assess the subjective vividness a participant experiences of their memory for an item. The scale's choices are 1 = Not Vivid, 2 = Slightly Vivid, 3 = Moderately Vivid, and 4 = Highly Vivid. The scale's responses will be averaged for each participant.

  Day 1 (first rTMS visit), Up to Day 14 (second rTMS visit)

Study Arms (1)

Healthy participants receiving rTMS

OTHER

Participation will require up to three visits. One visit will take up to an hour, and the other visits will each take up to three hours each. During the first visit, participants will be consented, and their brains will be scanned using magnetic resonance imaging. Participants will receive rTMS during two study visits.

Device: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) DEVICE

In the rTMS procedure a small plastic coil will be placed next to the participant's head. The position of the coil will be guided by neuro-navigational software utilizing the individual's MRI scan. The coil will be placed over the relevant brain region using the Brainsight TMS-MRI co-registration system for visualizing the coil position with respect to the participant's individual MRI scan. The coil will then generate a series of repetitive magnetic pulses, and stimulation will occur, disrupting typical function of the targeted brain region.

Healthy participants receiving rTMS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English speaking
• healthy

You may not qualify if:

• personal or first-degree family history of epileptic seizure
• a known brain injury
• claustrophobia
• taking certain medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline) or reduce the effects of rTMS, such as benzodiazepines
• current use of medication for neurological or psychiatric conditions
• internal metallic implant, device, or foreign body
• left handedness

Sponsors & Collaborators

• Stephan Hamann: lead

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Stephan Hamann, PhD

  Emory 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 INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 28, 2020
• Study Start: October 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share