Mechanism of Non-invasive Magnetic Stimulation

NCT03394066 | Recruiting FDA Device

• 2 other identifiers: 99991804218-DA-N042
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Transcranial magnetic stimulation (TMS) is form of non-invasive brain stimulation. It is approved to treat depression. TMS may help decrease drug craving. It is important to understand how TMS affects the brain. Such a better understanding would help to design ways to treat drug addiction. Objectives: To learn how TMS affects the brain when it stimulates an area in the front of the brain. Also, to see how the stimulation affects the area stimulated and other connected areas. Eligibility: Healthy, right-handed adults ages 18-60 who are non-drug users. Design: Participants will be screened under protocol 06-DA-N415. Participants will have at least 3 visits. The first visit will last about 3 hours. All other visits will last up to 6 hours. Participants cannot use drugs or alcohol at least 24 hours before a visit. They cannot have more than half a cup of a caffeinated drink at least 12 hours before a visit. Each visit will include a brief medical history update, urine test for drugs and pregnancy (if female), a breath test for alcohol and smoking, and questionnaires. Participants will have a TMS orientation visit. A wire coil will be placed on the head. An electrical current will pass through the coil to create a magnetic pulse that stimulates the brain. The other visits will include 2 sessions of TMS-MRI. Participants will lie on a table that slides into a cylinder. The TMS coil and the MRI coil will be placed over the head. Pictures will be taken of the brain with and without stimulation. Participants will complete a questionnaire about how they feel before and after each TMS session and in a follow-up call 1-3 days after their last session.

Conditions

Healthy Volunteers

Keywords

Repetitive TMS (rTMS); Simultaneous TMS and MRI

Outcome Measures

Primary Outcomes (1)

• effects of TMS on fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI.

  fMRI blood oxygen level-dependent (BOLD) responses, TMS induced changes on resting state functional connectivity, and their associations with relevant structural connectivity revealed by DTI

  TMS visits

Study Arms (1)

TMS

EXPERIMENTAL

All participants will receive TMS to investigate acute modulations of brain activity by TMS

Device: TMS (MagVenture MagPro 100 with MagOption)

Interventions

TMS (MagVenture MagPro 100 with MagOption) DEVICE

TMS will be applied using the MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) stimulator with a figure-of-eight TMS coil. An MRI compatible version of the figure-of-eight coil will be used inside the MRI scanner with an appropriate TMS coil holder.

TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must:
• Be 18 - 60 years of age.
• Justification: Many neural processes change with age, and these changes could introduce unwanted variability in both behavioral and MRI signals. In addition, the risk of difficult-to-detect medical abnormalities such as silent cerebral infarcts increases with age.
• Screening tool: History.
• Be in good health.
• Justification: Many illnesses may alter neural functioning as well as fMRI signals.
• Screening tools: Medical Assessment, Medical History and Physical Examination. Medical assessments include: Vital Signs, oral HIV test, height/weight measurements, and blood sample. Tests on the blood sample include CBC, Hemoglobin A1C, complete metabolic profile, ESR, and HIV (if needed to confirm a positive salivary test for HIV). The following individual laboratory results will independently disqualify individuals: Hemoglobin \< 10.5 g/dl, Hemoglobin A1C \>6.5%, WBC \< 2400/microliter, LFTs \> 3Xnormal, and Casual serum glucose \> 200 mg/dl. The MAI will retain discretion to exclude at less extreme values, depending on the clinical presentation. Elevated serum glucose may be followed up to assess for diabetes. MAI will make the final judgment on any questionable lab results.
• Right-handed.
• Justification: Using right-handed individuals will reduce variability in BOLD MRI data.
• Screening tool: self-report.

You may not qualify if:

• Personal history of stroke, brain lesions, previous neurosurgery, any personal history of seizure or fainting episode of unknown cause, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than two days.
• Justification: Stroke or head trauma can lower the seizure threshold and are therefore contraindications for TMS. Fainting episodes or syncope of unknown cause could indicate an undiagnosed condition associated with seizures. Neurological symptoms could potentially alter BOLD signal.
• Screening tool: TMS safety questionnaire and History and Physical including a neurological exam.
• First-degree family history of any form of epilepsy with a potentially hereditary basis.
• Justification: First-degree family history of epilepsy with a hereditary component increases the risk of the participant having an undiagnosed condition that is associated with lowered seizure threshold.
• Screening tool: TMS safety screening, Medical History.
• Cardiac pacemakers, neural stimulators, implantable defibrillator, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, -shunts, stimulators, cochlear implants, or electrodes) or any other metal object in the body that precludes either MRI scanning or TMS intervention.
• Justification: Any metal around the head is a contraindication for both MRI and TMS, as both methods involve exposure to a relatively strong magnetic field.
• Screening tool: TMS safety screening, MRI safety screening, Medical History.
• Any contraindications to MRI or TMS.
• Justification: There are additional contraindications that would exclude participation in MRI or TMS (e.g., claustrophobia).
• Screening tool: MRI safety screening, TMS Safety Screening, mock scanner trial (when available).
• Noise-induced hearing loss or tinnitus.
• Justification: individuals with noise-induced hearing problems may be particularly vulnerable to the acoustic noise generated by TMS and MRI equipment.
• Screening tools: TMS safety screening.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

RECRUITING

Related Publications (1)

• Caparelli EC, Schleyer B, Zhai T, Gu H, Abulseoud OA, Yang Y. High-Frequency Transcranial Magnetic Stimulation Combined With Functional Magnetic Resonance Imaging Reveals Distinct Activation Patterns Associated With Different Dorsolateral Prefrontal Cortex Stimulation Sites. Neuromodulation. 2022 Jun;25(4):633-643. doi: 10.1016/j.neurom.2022.03.002. Epub 2022 Apr 10.

  PMID: 35418339 DERIVED

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Yihong Yang, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

NIDA IRP Screening Team

CONTACT

(800) 535-8254; researchstudies@nida.nih.gov

Yihong Yang, Ph.D.

CONTACT

(667) 312-5364; yihongyang@intra.nida.nih.gov

Study Design

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

Study Record Dates

• First Submitted: January 6, 2018
• First Posted: January 9, 2018
• Study Start: September 19, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-02-25

Locations

US (1)