Regulating Homeostatic Plasticity and the Physiological Response to rTMS

November 16, 2020 updated by: University of Arkansas
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • transcranial direct current stimulation (tDCS), repetative transcranial magnetic stimulation (rTMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 16, 2017

Primary Completion (ACTUAL)

October 1, 2019

Study Completion (ACTUAL)

October 1, 2019

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (ACTUAL)

October 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206326

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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