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Trial record 96 of 80602 for:    measured

Effects of rTMS on Human Brain Activity Measured With EEG and fMRI

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ClinicalTrials.gov Identifier: NCT03259568
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : October 31, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

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 (fMRI and EEG), the investigators aim to resolve three interlocking problems in the design and application of rTMS: stimulation frequency, spatial targeting, and interactions with brain state.

Condition or disease Intervention/treatment Phase
Dose-response Study With rTMS Device: Repetitive TMS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of rTMS on Human Brain Activity Measured With EEG and fMRI
Actual Study Start Date : January 12, 2018
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Arm Intervention/treatment
Active Comparator: Active rTMS Device: Repetitive TMS
1-10 Hertz rTMS will be administered

Sham Comparator: Sham rTMS Device: Repetitive TMS
1-10 Hertz rTMS will be administered




Primary Outcome Measures :
  1. Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses) [ Time Frame: up to 3 months ]
  2. Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms) [ Time Frame: up to 3 months ]
  3. Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal [ Time Frame: up to 3 months ]
  4. Acute effect of a rTMS session on EEG recordings during a motion task, as measured by the change in neural oscillations [ Time Frame: up to 3 months ]


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259568


Contacts
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Contact: Alexandra C Brito, BA 919-668-1321 alexandra.brito@duke.edu
Contact: Lawrence G Appelbaum, PhD 919-613-7664 greg@duke.edu

Locations
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United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Alexandra C Brito, BA    919-668-1321    alexandra.brito@duke.edu   
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03259568     History of Changes
Other Study ID Numbers: Pro00082433
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
TMS