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Regulating Homeostatic Plasticity and the Physiological Response to rTMS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309696
Recruitment Status : Terminated (Funding issues)
First Posted : October 13, 2017
Results First Posted : November 6, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Description
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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 included an exploratory aim to examine physiological changes in patients with tinnitus but this aim was not part of the pilot physiological investigation and it could not be completed due to funding limitations.

Condition or disease Intervention/treatment Phase
Tinnitus Device: sham tDCS and sham rTMS Device: sham tDCS and active rTMS Device: active tDCS and active rTMS Not Applicable

Detailed Description:
Background and Rationale: The current proposal aims to combine two forms of neuromodulation, transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS), to regulate homeostatic plasticity prior to rTMS delivery at two different frequencies (1Hz and 10Hz). Homeostatic plasticity, the initial activation state of a targeted circuit, is a theoretical 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. Due to funding limitations, only the 1 Hz rTMS condition could be initiated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This prospective, experimental design includes a block randomized, blinded, sham controlled, mixed effects model with sequential assignment to treatment arms (1 or 10 Hz rTMS) and random assignment to the tDCS conditions within each arm. The order of the three experimental conditions within each arm is randomized.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Regulating Homeostatic Plasticity and the Physiological Response to rTMS
Actual Study Start Date : November 16, 2017
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arms and Interventions
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Arm Intervention/treatment
Experimental: tDCS and 1 Hz rTMS delivered over TC
Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC. .
 Device: sham tDCS and sham rTMS
Both combinations of tDCS and rTMS in this intervention are sham.
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: sham tDCS and active rTMS
tDCS in this intervention is sham and rTMS is active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: active tDCS and active rTMS
Both combinations of tDCS and rTMS in this intervention are active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)
Experimental: tDCS and 10Hz rTMS delivered over TC
Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
 Device: sham tDCS and sham rTMS
Both combinations of tDCS and rTMS in this intervention are sham.
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: sham tDCS and active rTMS
tDCS in this intervention is sham and rTMS is active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: active tDCS and active rTMS
Both combinations of tDCS and rTMS in this intervention are active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)
Experimental: tDCS over DLFC and 1 Hz rTMS over TC
Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
 Device: sham tDCS and sham rTMS
Both combinations of tDCS and rTMS in this intervention are sham.
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: sham tDCS and active rTMS
tDCS in this intervention is sham and rTMS is active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: active tDCS and active rTMS
Both combinations of tDCS and rTMS in this intervention are active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)
Experimental: tDCS over DLFC and 10 Hz rTMS over TC
Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.
 Device: sham tDCS and sham rTMS
Both combinations of tDCS and rTMS in this intervention are sham.
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: sham tDCS and active rTMS
tDCS in this intervention is sham and rTMS is active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

Device: active tDCS and active rTMS
Both combinations of tDCS and rTMS in this intervention are active
Other Name: transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)


Outcome Measures
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Primary Outcome Measures :
  1. Log Transformed P100 Amplitude of TEPs From the Global Mean Field Analysis. [ Time Frame: Up to 8 weeks ]
    TEPs refer to TMS-evoked EEG potentials. The P100 amplitude of TEPs is one means of assessing cortical excitability. The P100 amplitude has been shown to be a reliable metric in studies of healthy subjects. The P100 amplitude is used in this study to assess the excitation state of two regions of interest (ROIs), one in the TC and one in the DLPFC, at each period of TEP recording (i.e., Baseline, Post tDCS, Post rTMS, and 20 minute delay).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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,
Contacts and Locations
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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


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Mark Mennemeier, PhD University of Arkansas
  Study Documents (Full-Text)

Documents provided by University of Arkansas:
Study Protocol and Statistical Analysis Plan  [PDF] February 26, 2018

More Information
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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03309696    
Other Study ID Numbers: 206326
First Posted: October 13, 2017    Key Record Dates
Results First Posted: November 6, 2020
Last Update Posted: November 17, 2020
Last Verified: November 2020

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