Establishing Functional Biomarkers for Spaced Theta-Burst Stimulation

NCT03687892 | Terminated Results FDA Device

• 1 other identifier: 39234
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to use functional magnetic resonance imaging (fMRI) methods to assess brain changes following spaced theta burst stimulation (TBS), a new form of repetitive transcranial magnetic stimulation (rTMS), in 10 healthy participants. The investigators will measure the effects of both excitatory (intermittent, iTBS) and inhibitory (continuous, cTBS) TBS applied to the motor cortex, a system that when stimulated produces a readily observable behavioral response (e.g., movement of a given body regions). In addition to brain activity, we will assess the effects of TBS on motor responses and pain perception. The goal is to determine how brain activity and blood flow during tasks and at rest change following the applications of spaced cTBS and iTBS. Additionally, the aim is to determine the duration of the spaced TBS effects on brain activity and behavior. This study will provide an understanding of the functional brain and behavioral changes that occur following spaced TBS to the motor cortex and has implications for reducing the long treatment schedules associated with classical rTMS protocols.

Conditions

Healthy Volunteers

Keywords

repetitive Transcranial Magnetic Stimulation; functional MRI; Theta Burst Stimulation

Outcome Measures

Primary Outcomes (1)

• Changes in Motor Evoked Potential

  To determine the duration of effect of an application of a spaced TBS stimulation session (both inhibitory, cTBS and excitatory, iTBS) as measured by duration of change in motor evoked potential.

  Prior to and and immediately after TBS sessions on each day (separated by 3+ days)

Secondary Outcomes (3)

• Change From Baseline Resting-state Functional Connectivity Between the M1 Hotspot and Other Motor Areas Immediately Post-TBS

  Prior to and and immediately after TBS sessions on each day (separated by 3+ days)

• Change From Baseline Motor Cortex Activity as Assessed by the BOLD Signal Immediately Post-TBS

  Prior to and and immediately after TBS sessions on each day (separated by 3+ days)

• Changes in Arterial Perfusion

  Prior to and and immediately after TBS sessions on each day (separated by 3+ days)

Study Arms (2)

continuous Theta Burst Stimulation

EXPERIMENTAL

The investigators will perform two applications of 40s of continuous Theta Burst Stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left motor cortex will be determined by Localite Neuronavigation. The baseline structural scan obtained during the scan 1 will be utilized for this localization process.

Device: continuous Theta Burst Stimulation

intermittent Theta Burst Stimulation

EXPERIMENTAL

The investigators will perform two applications of 40s of intermittent Theta Burst Stimulation (iTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left motor cortex will be determined by Localite Neuronavigation. The baseline structural scan obtained during the scan 1 will be utilized for this localization process.

Device: intermittent Theta Burst Stimulation

Interventions

continuous Theta Burst Stimulation DEVICE

Continuous Theta Burst Simulation will be applied in a continuous manner resulting in cortical excitability.

Also known as: cTBS

continuous Theta Burst Stimulation

intermittent Theta Burst Stimulation DEVICE

Intermittent Theta Burst Stimulation will be applied in an intermittent manner resulting in cortical inhibition.

Also known as: iTBS

intermittent Theta Burst Stimulation

Eligibility Criteria

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

You may qualify if:

• Age 18 or older
• Right-handed
• Agree to having fMRI scan
• Willingness to suspend use of analgesic drugs or cough suppressants for 24 hours prior to the scans
• Proficiency in English sufficient to complete questionnaires/follow instructions during fMRI assessments
• US Citizen or resident able to receive payment legally

You may not qualify if:

• A medical condition that would contraindicate the use of rTMS
• Any condition that would contraindicate MRI (like ferromagnetic metal in the body)
• Pregnancy or breast feeding
• Any significant neurologic disease, including dementia, multi-infarct dementia, Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of significant head trauma
• Current antidepressant use (must be washed out for two weeks prior to starting protocol)
• Inability to stop taking medication contraindicated with treatment

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

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Results Point of Contact

• Title: Principal Investigator
• Organization: Stanford University

nbassano@stanford.edu

650-736-2233

Study Officials

• Nolan Williams, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: September 27, 2018
• Study Start: April 1, 2019
• Primary Completion: October 22, 2022
• Study Completion: October 22, 2022
• Last Updated: November 9, 2023
• Results First Posted: November 9, 2023

Record last verified: 2023-10

Locations

US (1)