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Regulating Homeostatic Plasticity and the Physiological Response to rTMS

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ClinicalTrials.gov Identifier: NCT03309696
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
This device-study includes a pilot, physiological investigation of normal human subjects. The aim is to determine how existing non-invasive neuromodulation devices affect brain circuitry as measured by EEG recording. Currently, the application of non-invasive neuromodulation is rarely guided by detailed knowledge of how neural activity is altered in the brain circuits that are targeted for intervention. This gap in knowledge is problematic for interpreting response variability, which is common. To address this gap, the current proposal aims to combine two forms of neuromodulation sequentially, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at different frequencies of rTMS. Homeostatic plasticity, the initial activation state of a targeted circuit, is a key determinant of whether rTMS induces long term potentiation (LTP) or long term depression (LTD) Yet, homeostatic plasticity is rarely measured or controlled in rTMS studies. We aim to control homeostatic plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The protocol also includes an exploratory aim to examine physiological changes in patients with tinnitus who only receive active stimulation, however, the exploratory aim is not part of the pilot physiological investigation.

Condition or disease Intervention/treatment Phase
Tinnitus Device: tDCS Device: rTMS Early Phase 1

Detailed Description:
Background and Rationale: The aim of this study is to determine how existing non-invasive neuromodulation devices affect brain physiology as measured by EEG recording. Currently, the use of non-invasive neuromodulation is rarely guided by a detailed knowledge of how neural activity is altered in the brain circuits that are targeted for intervention. This gap in knowledge is problematic for interpreting response variability, which is common. To address this gap, the current proposal aims to combine two forms of neuromodulation sequentially, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at different frequencies. Homeostatic plasticity, the initial activation state of a targeted circuit, is a key determinant of whether rTMS induces long term potentiation (LTP) or long term depression (LTD).Yet, homeostatic plasticity is rarely measured or controlled in rTMS studies. In a physiological investigation of health subjects, we aim to control homeostatic plasticity by preconditioning the targeted circuits with tDCS prior to rTMS delivery. The justification for this study is that controlling homeostatic plasticity can reduce subject variability and the knowledge gained can be used to optimize rTMS delivery. What is needed to move the field forward is a method for combining tDCS and rTMS and for measuring neuronal responses directly which we aim to establish in this study. The pilot study project will examine the targeted effects of neuromodulation in normal subjects. The brain regions targeted for intervention include auditory areas in the temporal cortex (TC) that process sounds and functionally connected regions of the dorsolateral frontal cortex (DLFC) that mediate sensory habituation.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Regulating Homeostatic Plasticity and the Physiological Response to rTMS
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Experimental: Experimental: tDCS over TC and 1 Hz rTMS Device: tDCS
transcranial direct current stimulation (tDCS)

Device: rTMS
repetitive transcranial magnetic stimulation (rTMS)

Experimental: Experimental: tDCS over TC and 10 Hzr rTMS Device: tDCS
transcranial direct current stimulation (tDCS)

Device: rTMS
repetitive transcranial magnetic stimulation (rTMS)

Experimental: Experimental: tDCS over DLFC and 1 Hz rTMS Device: tDCS
transcranial direct current stimulation (tDCS)

Device: rTMS
repetitive transcranial magnetic stimulation (rTMS)

Experimental: Experimental: tDCS over DLFC and 10 Hz rTMS Device: tDCS
transcranial direct current stimulation (tDCS)

Device: rTMS
repetitive transcranial magnetic stimulation (rTMS)




Primary Outcome Measures :
  1. Change in cortical excitability - the local mean field potential [ Time Frame: Up to 8 weeks ]
    The local mean field potential of regions of interest over the temporal and frontal cortex will be measured from TMS evoked electroencephlagram (EEG) potentials (TEPs).



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • complete the informed consent process
  • men and women, age: 21-65 years
  • negative pregnancy test (female subjects of childbearing age must take a pregnancy test).

Exclusion Criteria:

  • a personal or family history of epilepsy,
  • severe head injury, aneurysm, stroke, previous cranial neurosurgery,
  • sever or recurrent migraine headaches,
  • metal implants in the head or neck, a pacemaker,
  • pregnancy,
  • medications that lower seizure threshold,

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): NCT03309696


Contacts
Contact: Mark S Mennemeier, PhD 205-410-2413 msmennemeier@uams.edu
Contact: David Dobry, BS 501-413-8246 djdobry@uams.edu

Locations
United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Mark Mennemeier, PhD    501-526-7773    msmennemeier@uams.edu   
Sub-Investigator: John Dornhoffer, MD         
Sub-Investigator: Linda Larson-Prior, PhD         
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Mark Mennemeier, PhD University of Arkansas

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03309696     History of Changes
Other Study ID Numbers: 206326
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

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: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms