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

NCT03263013 | Completed

• 2 other identifiers: 17016017-N-0160
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Movement Disorders

Keywords

Functional (BOLD) MRI

Outcome Measures

Primary Outcomes (1)

• to evaluate the safety and feasibility of different doses of iTBS of the left DLPFC in patients with FMD.

  Percent of subjects experiencing adverse events (i.e., seizures, etc.)

  throughout life of the protocol

Study Arms (1)

FMD patients

patients with a diagnosis of clinically definite FMD who have been assessed at the HMCS clinic, and who have completed protocol 07-N-0190.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

FMD subjects will be recruited from patients assessed at the HMCS Clinic of NINDS/NIH, from the HMCS database, and from protocol 07-N-0190. Patients who have previously participated in protocol 07-N-0190 will be contacted over the telephone and offered participation in the study.

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Stone J, Carson A, Duncan R, Roberts R, Coleman R, Warlow C, Murray G, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Sharpe M. Which neurological diseases are most likely to be associated with "symptoms unexplained by organic disease". J Neurol. 2012 Jan;259(1):33-8. doi: 10.1007/s00415-011-6111-0. Epub 2011 Jun 16.

  PMID: 21674198 BACKGROUND

• Carson A, Stone J, Hibberd C, Murray G, Duncan R, Coleman R, Warlow C, Roberts R, Pelosi A, Cavanagh J, Matthews K, Goldbeck R, Hansen C, Sharpe M. Disability, distress and unemployment in neurology outpatients with symptoms 'unexplained by organic disease'. J Neurol Neurosurg Psychiatry. 2011 Jul;82(7):810-3. doi: 10.1136/jnnp.2010.220640. Epub 2011 Jan 21.

  PMID: 21257981 BACKGROUND

• Gelauff J, Stone J, Edwards M, Carson A. The prognosis of functional (psychogenic) motor symptoms: a systematic review. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):220-6. doi: 10.1136/jnnp-2013-305321. Epub 2013 Sep 12.

  PMID: 24029543 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 28, 2017
• Study Start: March 29, 2018
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)