NCT03309696|TerminatedResultsFDA Device
Study Stopped
Funding issues
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Funding issues
Sponsor study identifier
interventional
10
1 country
1
Study Start
November 16, 2017
Actual (reported)Primary Completion
October 1, 2019
Actual (reported)Study Completion
October 1, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 9, 2017
Actual (reported)October 13, 2017
Actual (reported)November 16, 2017
Actual (reported)October 1, 2019
Actual (reported)October 1, 2019
Actual (reported)November 6, 2020
Actual (reported)Log Transformed P100 Amplitude of TEPs From the Global Mean Field Analysis.
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
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. .
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.
Both combinations of tDCS and rTMS in this intervention are sham.
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Our pilot study funding ended. Subjects could not be recruited for the 10 Hz rTMS arm. A proposed study of tinnitus patients could not be initiated. Data analysis could only be completed for one arm.
Mark Mennemeier, PhD
University of Arkansas
10 participants (actual enrollment reported by the registry).
First Submitted
October 9, 2017
First Posted
October 13, 2017
Reversing Synchronized Brain Circuits With Targeted Auditory-Somatosensory Stimulation to Treat Phantom Percepts
Acoustic and Electrical Stimulation for the Treatment of Tinnitus
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.
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.
tDCS in this intervention is sham and rTMS is active
Both combinations of tDCS and rTMS in this intervention are active
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Start
November 16, 2017
Actual (reported)Primary Completion
October 1, 2019
Actual (reported)Study Completion
October 1, 2019
Actual (reported)Last Updated
November 17, 2020
Results First Posted
November 6, 2020
Record last verified: 2020-11
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Source: ClinicalTrials.gov.
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