iTBS Methods and Motor Cortex Excitability

NCT03584438 | Completed Early Phase 1 DMC FDA Device

• 1 other identifier: 68775
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In a recent publication by Gamboa et al. 20108 it was shown that extended theta-burst stimulation duration might have reverse effects on cortical excitability when compared to the original Huang et al. 2005 publication. While the post treatment effects of the original Huang et al. 2005 protocol were successfully replicated, when continuous theta burst stimulation (cTBS) protocols were doubled to 1200 pulses over 80 seconds and the iTBS protocols were doubled to 1200 pulses over 390 seconds, there was increased facilitation after the prolonged cTBS and decreased excitability after prolonged iTBS. Currently there is an interest in optimizing repetitive transcranial magnetic stimulation (rTMS) protocols and in particular theta burst stimulation as both a therapeutic and an investigational tool. In Hanlon et al. 2015, a novel theta burst paradigm is described in which two trains of 1800 pulses of cTBS were administered, each train separated by a one-minute interval. In this study 11-cocaine dependent individuals underwent cTBS over the medial prefrontal cortex (MPFC) and showed attenuated craving as well as decreases in activity of the striatum and anterior insula. This study aims to replicate the findings of the Gamboa and Huang protocols as well as investigate how novel theta burst stimulation paradigms such as those described in Hanlon et al. 2015, which are currently being explored as therapeutic methods in addiction may change cortical excitability.

Conditions

Motor Activity

Keywords

TMS; Motor Cortex; Excitability; LTP; LTD

Outcome Measures

Primary Outcomes (1)

• Effects of theta burst stimulation protocols of LTP-like and LTD-like stimulation on change in motor cortex excitability

  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.

  Through study completion, an average of two weeks.

Study Arms (5)

Hanlon Real iTBS Protocol 1

EXPERIMENTAL

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.

Device: Real iTBS

Hanlon Real iTBS Protocol 2

EXPERIMENTAL

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.

Device: Real iTBS

Huang Real iTBS Protocol

EXPERIMENTAL

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).

Device: Real iTBS

Gamboa Real iTBS Protocol

EXPERIMENTAL

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).

Device: Real iTBS

Sham iTBS protocol

SHAM COMPARATOR

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.

Device: Sham iTBS

Interventions

Real iTBS DEVICE

This will be delivered with the Magventure Magpro system; pulses are delivered with the active coil (double blinded using the Universal Serial Bus key)

Gamboa Real iTBS Protocol; Hanlon Real iTBS Protocol 1; Hanlon Real iTBS Protocol 2; Huang Real iTBS Protocol

Sham iTBS DEVICE

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.

Sham iTBS protocol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults (18 - 65 years of age)
• Able to read and understand questionnaires and informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• MUSC Center for Biomedical Research Excellence in Stroke Recovery: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Lisa McTeague, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 30 healthy controls will undergo four Active TMS treatment sessions (separated by at least 24 hrs), along with a Sham TMS treatment session. The theta-burst treatments will be counterbalanced across participants.

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 12, 2018
• Study Start: May 26, 2018
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: March 12, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)