- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03584438
iTBS Methods and Motor Cortex Excitability
The Effects of Theta-Burst Stimulation Duration on Human Motor Cortex Excitability
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
rTMS is a method of non-invasive neuromodulation. Although TMS (transcranial magnetic stimulation) has widely been used as a research method to better understand brain neurophysiology, rTMS protocols have been shown to be clinically beneficial to patients suffering from neurological disorders such as Parkinson's Disease and stroke as well as psychiatric diseases such as major depression. In October of 2008 the FDA approved 10 Hertz (Hz) dorsolateral prefrontal cortex (DLPFC) stimulation for patients with medication resistant depression. The typical duration of a single rTMS treatment for depression lasts for about 30 minutes, but must be repeated daily over several weeks. The decision to use DLPFC stimulation was due in part to imaging studies, which suggested depressed patients had decreased activity in the region. Thus, rTMS could be used to reverse those behavioral effects of depression by increasing activity in the DLPFC. Traditionally 5 Hertz (Hz) stimulation and upward has been shown to be excitatory while stimulation of 0.2-1 Hertz (Hz) has been shown to have inhibitory effects on the cortex. Although these parameters appear to be efficacious the development of new rTMS methods are still being explored.
Theta burst stimulation (TBS) is a method with the potential of providing excitatory or inhibitory effects on the cortex, which are as powerful as traditional rTMS methods yet more efficient in duration and intensity required. Evidence from previous studies looking at theta burst as a treatment for depression has highlighted the importance of the method's development. One study indicated that theta-burst stimulation over the dorsomedial prefrontal cortex (DMPFC) for a duration of just 6 minutes can produce comparable anti-depressant effects to traditional 10Hz stimulation over 30 minutes. Theta burst stimulation effects were first empirically tested on the human motor cortex by Huang et al. 2005. The effects of stimulation (80% of active motor threshold) over the motor cortex were measured pre and post treatment with electromyography (EMG) recordings of motor evoked potentials (MEPs) on a small contralateral hand muscle in response to single pulses of TMS. Two protocols showed changes in excitability of the corticospinal tract, including cTBS defined as three burst stimuli at 50 Hz with 20ms between stimuli repeated every 200ms at 5Hz and iTBS defined as a 2s train of TBS repeated every 10 seconds. Although both protocols deliver a total of 600 pulses, the cTBS protocols lasts for 40 seconds while the iTBS protocol lasts for 190 seconds. Huang et al. 2005 determined that cTBS over motor cortex decreased excitability while iTBS increased excitability which were present an hour following treatment.
The excitability of the motor cortex may be modulated differently depending on the type of theta burst stimulation protocol utilized. iTBS was originally described by Huang et al. 2005 resulting in an excitatory effects (LTP like) on the cortex. Gamboa et al. 2010 later confirmed this finding but showed that there was a decrease in excitability (LTD-like) when the protocol is doubled. Both of these protocols are to be replicated and in addition 2 new protocols. In order to investigate how cortical excitability changes as a function of protocol, MEPs will be recorded using EMG on the hand muscle contralateral to the stimulated cortex. Baseline MEPs will be obtained pretreatment, followed by one of the four theta burst protocols, or a sham treatment. Theta burst protocols are to be administered to each participant in randomized order. After theta burst is administered 20 MEPs will be collected at 0, 10, 20, 30, 40, 50 and 60 minutes.
Specific Aim 1: To determine the long-term potentiation (LTP) like and long-term depression (LTD) like effects of four different theta burst stimulation protocols on motor cortex excitability.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy adults (18 - 65 years of age)
- Able to read and understand questionnaires and informed consent
Exclusion Criteria:
- Pregnancy, females of child bearing age must undergo a pregnancy test to confirm eligibility;
- History of seizure disorder or post-stroke seizure;
- Implanted medical devices or metal in head (except braces);
- Preexisting scalp lesion or wound or bone defect or hemicraniectomy;
- Left-hand dominance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hanlon Real iTBS Protocol 1
One session of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left motor cortex.
600 pulses of iTBS over the motor cortex (C3), 3600 pulses are delivered over 19 minutes.
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This will be delivered with the Magventure Magpro system; pulses are delivered with the active coil (double blinded using the Universal Serial Bus key)
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Experimental: Hanlon Real iTBS Protocol 2
One session of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left motor cortex.
600 pulses of iTBS over the motor cortex (C3), 1800 pulses are delivered over 9 minutes and 30 seconds.
|
This will be delivered with the Magventure Magpro system; pulses are delivered with the active coil (double blinded using the Universal Serial Bus key)
|
Experimental: Huang Real iTBS Protocol
One session of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left motor cortex.
(2 sec trains of tbs every 10 sec) was applied over the left motor cortex (C3) for 190 seconds (a total of 600 TMS pulses).
|
This will be delivered with the Magventure Magpro system; pulses are delivered with the active coil (double blinded using the Universal Serial Bus key)
|
Experimental: Gamboa Real iTBS Protocol
One session of real intermittent Theta Burst Stimulation (iTBS) will be delivered to the left motor cortex.
(2 sec trains of tbs every 10 sec) was applied over the left motor cortex (C3) for 380 seconds (a total of 1200 TMS pulses).
|
This will be delivered with the Magventure Magpro system; pulses are delivered with the active coil (double blinded using the Universal Serial Bus key)
|
Sham Comparator: Sham iTBS protocol
One session of sham intermittent Theta Burst Stimulation (iTBS) will be delivered to the left motor cortex.
The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin over the left motor cortex (C3) and beneath the coil.
|
This will be delivered with the Magventure Magpro system; pulses are delivered with the sham coil (double blinded using the Universal Serial Bus key).
The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of theta burst stimulation protocols of LTP-like and LTD-like stimulation on change in motor cortex excitability
Time Frame: Through study completion, an average of two weeks.
|
The excitability of the motor cortex may be modulated differently depending on the type of TBS protocol utilized.
iTBS was originally described by Huang et al. 20057 resulting in an excitatory effects (LTP like) on the cortex.
Gamboa et al. 20108 later confirmed this finding but showed that there was a decrease in excitability (LTD-like) when the protocol is doubled.
Both of these protocols are to be replicated and in addition 2 new protocols.
In order to investigate how cortical excitability changes as a function of protocol, MEPs (motor evoked potentials) will be recorded using EMG (electromyography) on the hand muscle contralateral to the stimulated cortex.
Baseline MEPs will be obtained pretreatment, followed by one of the four theta burst protocols, or a sham treatment.
Theta burst protocols are to be administered to each participant in randomized order.
After theta burst is administered 20 MEPs will be collected at 0, 10, 20, 30, 40, 50 and 60 minutes.
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Through study completion, an average of two weeks.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa McTeague, PhD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 68775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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