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History of Changes for Study: NCT03309696
Regulating Homeostatic Plasticity and the Physiological Response to rTMS
Latest version (submitted November 16, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2017 None (earliest Version on record)
2 November 16, 2017 Recruitment Status, Study Status and Contacts/Locations
3 November 26, 2018 Study Status and Study Design
4 December 3, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 October 1, 2020
Quality Control Review has not concluded Returned: October 23, 2020
Arms and Interventions, Study Status, Study Design, Outcome Measures, Study Description, Document Section
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Results Submission Events
6 November 5, 2020 Baseline Characteristics, Study Status, Outcome Measures, Adverse Events, Participant Flow
7 November 16, 2020 Study Status
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Study NCT03309696
Submitted Date:  October 9, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: 206326
Brief Title: Regulating Homeostatic Plasticity and the Physiological Response to rTMS
Official Title: Regulating Homeostatic Plasticity and the Physiological Response to rTMS
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2017
Overall Status: Not yet recruiting
Study Start: October 30, 2017
Primary Completion: October 30, 2019 [Anticipated]
Study Completion: October 30, 2019 [Anticipated]
First Submitted: October 9, 2017
First Submitted that
Met QC Criteria:
October 9, 2017
First Posted: October 13, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
October 9, 2017
Last Update Posted: October 13, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Arkansas
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
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.
Open or close this module Conditions
Conditions: Tinnitus
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Basic Science
Study Phase: Early Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: Single (Participant)
Allocation: Randomized
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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)
Open or close this module Outcome Measures
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).
Open or close this module Eligibility
Minimum Age: 21 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
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,
Open or close this module Contacts/Locations
Central Contact Person: Mark S Mennemeier, PhD
Telephone: 205-410-2413
Email: msmennemeier@uams.edu
Central Contact Backup: David Dobry, BS
Telephone: 501-413-8246
Email: djdobry@uams.edu
Study Officials: Mark Mennemeier, PhD
Principal Investigator
University of Arkansas
Locations: United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Contact:Contact: Mark Mennemeier, PhD 501-526-7773 msmennemeier@uams.edu
Contact:Sub-Investigator: John Dornhoffer, MD
Contact:Sub-Investigator: Linda Larson-Prior, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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