Effects of rTMS on Human Brain Activity Measured With fMRI

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.

Study Overview

• Status: Terminated
• Conditions: Human Brain Activity
• Intervention / Treatment: Device: Repetitive TMS

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Repetitive TMS; 1-10 Hertz rTMS will be administered
Experimental: 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.	Device: Repetitive TMS; 1-10 Hertz rTMS will be administered
Experimental: 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.	Device: Repetitive TMS; 1-10 Hertz rTMS will be administered
Experimental: 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.	Device: Repetitive TMS; 1-10 Hertz rTMS will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motion Perception Accuracy	Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)	during each TMS session, up to 3 hours
Reaction Time	Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)	during each TMS session, up to 3 hours
Activation of Cortical Networks During a Visual Motion Task.	Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal	during each TMS session, up to 3 hours

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2018
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 21, 2017
• First Posted (Actual): August 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: TMS; BOLD activity; Network activity
• Other Study ID Numbers: Pro00082433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No