Effects of rTMS on Human Brain Activity Measured With fMRI

NCT ID: NCT03259568

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2019-08-20

Brief Summary

This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on neural circuits as a function of spatiotemporal parameters and brain state in order to better understand why the method works and how to improve its efficacy. Leveraging our expertise in application of TMS methodology during concurrent single neuron recording techniques in non-human primates and imaging and scalp potential techniques in humans, the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.

Conditions

Human Brain Activity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Dose-response TMS - Intensity = 20%RMT

Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.

Outcome measures include accuracy, RT, and BOLD signal.

Group Type: EXPERIMENTAL

Repetitive TMS

Intervention Type: DEVICE

1-10 Hertz rTMS will be administered

Dose-response TMS - Intensity = 40%RMT

Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.

Outcome measures include accuracy, RT, and BOLD signal.

Group Type: EXPERIMENTAL

Repetitive TMS

Intervention Type: DEVICE

1-10 Hertz rTMS will be administered

Dose-response TMS - Intensity = 80%RMT

Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.

Outcome measures include accuracy, RT, and BOLD signal.

Group Type: EXPERIMENTAL

Repetitive TMS

Intervention Type: DEVICE

1-10 Hertz rTMS will be administered

Dose-response TMS - Intensity = 120%RMT

Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.

Outcome measures include accuracy, RT, and BOLD signal.

Group Type: EXPERIMENTAL

Repetitive TMS

Intervention Type: DEVICE

1-10 Hertz rTMS will be administered

Interventions

Repetitive TMS

1-10 Hertz rTMS will be administered

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age between 18-30.

2. Use of effective method of birth control for women of childbearing capacity.

3. Willing to provide informed consent.

Exclusion Criteria

1. Current or recent (within the past 6 months) of substance abuse or dependence, excluding nicotine and caffeine (urine test).

2. Current serious medical illness (self report).

3. 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); [TMS Adult Safety Screening (TASS) form].

4. Subjects are unable or unwilling to give informed consent.

5. Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)

6. Subjects with a clinically defined neurological disorder including, but not limited to:

1. Any condition likely to be associated with increased intracranial pressure

2. Space occupying brain lesion.

3. History of stroke.

4. Transient ischemic attack within two years.

5. Cerebral aneurysm.

6. Dementia.

7. Mini Mental Status Exam (MMSE) score of <24.

8. Parkinson's disease.

9. Huntington's disease.

i. Multiple sclerosis.

7. Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold.

8. Subjects with cochlear implants

9. Subjects not willing to tolerate the confinement associated with being in the MRI scanner.

10. Women who are pregnant or breast-feeding (urine test).

11. Blindness.

12. Inability to read or understand English.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00082433

Identifier Type: -

Identifier Source: org_study_id