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

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT03259568
Collaborator
(none)
97
Enrollment
1
Location
2
Arms
19.2
Actual Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Repetitive TMS
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
97 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 :
Jan 12, 2018
Actual Primary Completion Date :
Aug 20, 2019
Actual Study Completion Date :
Aug 20, 2019

Arms and Interventions

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

Outcome Measures

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) [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) [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 [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 [up to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

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

  8. Space occupying brain lesion.

  9. History of stroke.

  10. Transient ischemic attack within two years.

  11. Cerebral aneurysm.

  12. Dementia.

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

  14. Parkinson's disease.

  15. Huntington's disease.

  1. Multiple sclerosis.

  1. 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.

  2. Subjects with cochlear implants

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

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

  5. Blindness.

  6. Inability to read or understand English.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke University Medical Center Durham North Carolina United States 27705

Sponsors and Collaborators

  • Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03259568
Other Study ID Numbers:
  • Pro00082433
First Posted:
Aug 23, 2017
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Duke University
TMS

Study Results

No Results Posted as of Jan 26, 2022