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Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in People With Functional Movement Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03263013
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:

Background:

Functional movement disorder (FMD) causes involuntary movements, such as spasms, shaking, or jerks. These symptoms are not due to a recognized neurological or medical cause. Researchers want to better understand how the brain works to cause these symptoms.

Objective:

To test if intermittent theta burst stimulation (iTBS) affects brain areas involved in FMD symptoms. Also, to look at the effect of iTBS on mood and motor symptoms.

Eligibility:

Right-handed people ages 18-65 who have FMD and participated in protocol 07-N-0190

Design:

Participants will have 4 visits.

In Visit 1, participants will be screened with:

Medical history

Physical exam

Urine test

Questionnaires

Visit 1 might also include a brain MRI and functional MRI. The MRI scanner is a cylinder surrounded by a strong magnetic field. They will lie on a table that can slide in and out of the cylinder. For the functional MRI, they will be asked to perform tasks during the MRI scan.

Visit 2 will be 1-2 weeks after Visit 1. Visits 2, 3, and 4 will be no more than 48 hours apart. These include:

Electromyography: Small electrodes are taped to the skin. Muscle activity is recorded while participants receive magnetic stimulation of the brain.

Transcranial magnetic stimulation and iTBS: A wire coil is held on the scalp. A brief electrical current passes through the coil and creates a magnetic pulse to stimulate the brain. During iTBS, participants will sit quietly and watch a nature documentary. They will wear earplugs and a cap.

MRI

Functional MRI

Questionnaires


Condition or disease
Movement Disorders

Detailed Description:

Objectives:

The purpose of this protocol is to investigate feasibility and safety of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). We further aim at exploring whether iTBS of the DLPFC modulates amygdala activity, by investigating iTBS effects on resting-state fronto-amygdala connectivity and on amygdala BOLD response to valenced stimuli.

Study population:

FMD patients (N=6), aged 18-65 years, admitted at the Human Motor Control Section (HMCS) clinic, who have completed protocol 07-N-0190.

Design:

Participants will undergo four outpatient visits. On Visit #1 (baseline), patients will undergo a screening session to assess their eligibility to participate in the current study. They will undergo neurological and psychiatric assessment, as well as structural and functional magnetic resonance imaging. Intermittent TBS will be performed on three separated visits (Visit #2, #3 and #4; iTBS1, iTBS 2 and iTBS 3). During each visit, participants will receive three iTBS sessions over 1-hour, with a 15-minute interval between sessions. Each session will last 190 seconds and a total of 600 pulses will be delivered. Magnetic field intensity will be set at 120% of that participants observed daily resting motor threshold. The target will be identified using the neuronavigation system Brainsight. Following each iTBS visit, behavioral and functional imaging data will be collected.

Outcome measures:

Our primary outcomes will be to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD. In addition, in order to investigate amygdala engagement by DLPFC iTBS, the following exploratory outcomes will be analyzed: (1) Amygdala BOLD signal change in response to valenced stimuli, from baseline to iTBS3; (2) Amygdala BOLD signal change in response to valenced stimuli, from baseline to each timepoint (iTBS1- iTBS3), for each valence stimuli; (3) Change in fronto-amygdalar resting state functional connectivity, from baseline to iTBS3 (z-score); (4) Change in fronto-amygdalar resting state functional connectivity from baseline to each time point (iTBS1- iTBS3); (5) Change in the valence and arousal subjective levels, using the self-assessment Manikin, from baseline to each time point (iTBS1- iTBS3); (6) Correlations of percent amygdala BOLD signal change with changes in arousal and valence level; (7) Change in the scores on the simplified version of the FMD-RS from pre- to post treatment, for each timepoint.

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Study Type : Observational
Actual Enrollment : 7 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Patients With Functional Movement Disorders
Actual Study Start Date : March 29, 2018
Actual Primary Completion Date : February 5, 2020
Actual Study Completion Date : February 5, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients
patients with functional movement disorders (FMD)



Primary Outcome Measures :
  1. to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD. [ Time Frame: baseline, visit 4 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with functional movement disorders (FMD)
Criteria
  • INCLUSION CRITERIA:
  • Diagnosis of clinically definite functional movement disorder (as made by a neurologist)
  • Ability to give informed consent
  • Male and female participants between 18- 65 years of age
  • Participation in protocol 07-N-0190
  • Right handed (self-report)
  • Ability to comply with all study procedures
  • Abstinence from alcohol for at least 48 hrs prior to the study and caffeine on the day ofthe study (based on oral interview)

EXCLUSION CRITERIA:

  • History of significant central nervous system disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders, multiple sclerosis or epilepsy (clinical exam, MRI findings)
  • History of psychotic disorder or bipolar disorder (clinical exam and/or SCID). Current acute mania and psychosis will also be excluded. As some degree of depressive symptoms is common in FMD patients, moderate unipolar depression will not be exclusionary (HAM-D score less than or equal to 18 will not be excluded)
  • Current obsessive compulsive disorder (OCD) or post-traumatic stress disorder (PTSD)
  • Active illicit substance use within the last 6 months (clinical exam and/or SCID).
  • Current suicidal ideation (Columbia-Suicide Severity Rating Scale)
  • Disease severity requiring inpatient treatment (clinical exam)
  • Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI (clinical exam)
  • Previous brain neurosurgery (self-reported history)
  • History of head trauma that resulted in loss of consciousness for more than several seconds (self-reported history, TMS safety screening questionnaire, MRI findings)
  • Regular use in the past 2 weeks of any of the following classes of medications: antiepileptics (except benzodiazepines, gabapentin and pregabalin), anti-parkinsonian medications, muscle relaxants, opiate medications and tricyclic antidepressants (selfreported history)
  • Any history of seizures other than febrile childhood seizures (self-reported history)
  • Family history of epilepsy (self-reported history, TMS safety screening)
  • Patients with recurring fainting spells (self-reported history, TMS safety screening)
  • Significant medical illness, including liver failure, kidney failure, congestive heart failure (clinical exam and/or medical records)
  • Patients with documented hearing loss greater than or equal to 15dB at any frequency (medical records)
  • Any psychiatric, medical or social condition whether or not listed above, due to which, in the judgment of the PI and after any consults if indicated, participation in the study is not in the best interest of the patient.
  • Breastfeeding (self-report)
  • NINDS employee/staff
  • Subjects who have contraindications to MRI (we will follow the NMR Center guidelines for MR safety). Some of the exclusions are:

    • Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe.
    • Unable to lie flat on the back for the expected length of the experiment (50 minutes).
    • Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis.
    • Uncomfortable being in a small space for the expected length of the experiment (50 minutes).
    • Non-removable body piercing or tattoo posing MRI risk
    • Pregnancy (urine pregnancy test)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03263013


Locations
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United States, Maryland
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT03263013    
Other Study ID Numbers: 170160
17-N-0160
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 5, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
Functional (BOLD) MRI
Additional relevant MeSH terms:
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Movement Disorders
Conversion Disorder
Central Nervous System Diseases
Nervous System Diseases
Somatoform Disorders
Mental Disorders