Effects of rTMS on Human Brain Activity Measured With fMRI

NCT03259568 | Terminated Results FDA Device

• 1 other identifier: Pro00082433
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

TMS; BOLD activity; Network activity

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Dose-response TMS - Intensity = 20%RMT

EXPERIMENTAL

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

Dose-response TMS - Intensity = 40%RMT

EXPERIMENTAL

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

Dose-response TMS - Intensity = 80%RMT

EXPERIMENTAL

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

Dose-response TMS - Intensity = 120%RMT

EXPERIMENTAL

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

Interventions

Repetitive TMS DEVICE

1-10 Hertz rTMS will be administered

Dose-response TMS - Intensity = 120%RMT; Dose-response TMS - Intensity = 20%RMT; Dose-response TMS - Intensity = 40%RMT; Dose-response TMS - Intensity = 80%RMT

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18-30.
• 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) of 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); \[TMS Adult Safety Screening (TASS) form\].
• 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.
• Mini Mental Status Exam (MMSE) score of \<24.
• Parkinson's disease.
• Huntington's disease.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Results Point of Contact

• Title: Simon W Davis
• Organization: Dept of Neurology, Duke University School of Medicine

simon.davis@duke.edu

9195991927

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is not informed about TMS intensity.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study ("arms") are repeated within each participant (20%, 40%, 80%, or 120% of an individual's titrated resting motor threshold).

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 23, 2017
• Study Start: January 12, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: March 29, 2023
• Results First Posted: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)