Effects of rTMS on Human Brain Activity

NCT04242810 | Withdrawn FDA Device

• 1 other identifier: Pro00102980
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate how repetitive transcranial magnetic stimulation (rTMS) affects brain networks measured by functional magnetic resonance imaging (fMRI). Participants will undergo a screening that includes a psychiatric and medical history screening, TMS and MRI safety screening, and urine screening. If participants pass the screening procedure, they will be introduced to transcranial magnetic stimulation (TMS), magnetic resonance imaging (MRI), and a task that involves viewing words, sentences, or pictures. There will be up to seven visits and each visit will take less than 3 hours. MRI can be dangerous for people that have medical devices, metal objects, or metal debris in their bodies. TMS procedures are associated with a very low risk of seizures, "muscle-tension" type headache, ear damage, numbness of the face, fainting, dizziness, memory impairment, trouble concentrating, and acute mood changes. This study will use only levels of TMS that are within safety guidelines. There is also a risk of potential loss of confidentiality.

Conditions

Repetitive Transcranial Magnetic Stimulation (rTMS)

Outcome Measures

Primary Outcomes (3)

• Effect of a rTMS session on the performance for a memory task, as measured by accuracy (in percentage of correct responses)

  up to 1 month

• An effect of a rTMS session on the performance for a memory task, as measured by reaction time (in ms)

  Time frame: up to 1 month

• An effect of a rTMS session on fMRI brain representation for a memory task, as measured by BOLD signal

  up to 1 month

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

rTMS applied over memory task-based brain target

Device: rTMS; Procedure: MRI scan

Sham rTMS

PLACEBO COMPARATOR

Sham rTMS applied over memory task-based brain target

Device: Sham rTMS; Procedure: MRI scan

Interventions

rTMS DEVICE

TMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system.

Active rTMS

Sham rTMS DEVICE

An electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control.

Sham rTMS

MRI scan PROCEDURE

Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age restrictions: between 18-35 years old
• Use of effective method of birth control for women of childbearing capacity.
• Willing to provide informed consent.

You may not qualify if:

• Current or recent (within the past 6 months) substance abuse or dependence, excluding nicotine and caffeine (urine test)
• Current serious medical illness (self-report)
• History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, cranial metal implants, known structural brain lesion, devices that may be affected by rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
• Subjects are unable or unwilling to give informed consent
• Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)
• Subjects with a clinically defined neurological disorder including, but not limited to:
• Any condition likely to be associated with increased intracranial pressure
• Space occupying brain lesion.
• History of stroke.
• Transient ischemic attack within two years.
• Cerebral aneurysm.
• Dementia.
• Parkinson's disease.
• Huntington's disease.
• Multiple sclerosis.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Robert Cabeza

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 27, 2020
• Study Start: December 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)