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NCT Number: NCT05155059

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

Background:

Functional movement disorders (FMD) involve involuntary movements that are not due to a recognized neurological or medical cause. FMD can cause major disability. Researchers want to learn more to create better treatments for FMD.

Objective:

To test whether non-invasive brain stimulation using transcranial magnetic stimulation (TMS) improves FMD symptoms.

Eligibility:

People between the ages of 18 and 80 who have been diagnosed with FMD by a neurologist.

Design:

Participants will be randomly assigned to one of two groups. One group is an active brain stimulation group and the other is a sham brain stimulation group.

Participants will have a baseline visit. This will include:

Neurological exam

Questionnaires

Urine test

Brain MRI: Participants will lie in a machine that takes pictures of the body. They will be asked to respond to images on a screen while in the scanner.

Within 2 weeks of the baseline visit, participants will begin 5 daily sessions of TMS. The active group will have stimulation delivered to the brain via a coil. In the sham group, a dummy coil will be used that will not deliver stimulation. A total of three 3-minute cycles will be done in one visit. There will be 20-minute breaks between the cycles.

Participants will have visits 1 month, 2 months, and 6 months after their last day of TMS. Their FMD symptoms will be evaluated. They will complete health questionnaires. These visits can be in person or virtual.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Functional Movement Disorder Conversion Disorder Mental Disorders Somatoform Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

Study Description:

The purpose of this protocol is to investigate efficacy of intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (DLPFC) in patients with functional movement disorders (FMD). Participants will be randomly assigned to receive either active iTBS or sham stimulation of the left DLPFC for 5 consecutive daily sessions.

Objectives:

Primary Objective: To investigate efficacy of iTBS of the left DLPFC on motor symptoms in patients with FMD

Secondary Objectives: To investigate efficacy of iTBS of the left DLPFC on mood symptoms and its effect on fronto-amygdala circuit on functional neuroimaging

Endpoints:

Primary Endpoint: Relative change in Functional Movement Disorder Rating Scale (S-FMDRS) from the baseline to 1 month after iTBS vs sham: 100 *( S-FMDRS at one-month - S-FMDRS at baseline)/ S-FMDRS at baseline

Secondary Endpoints:

  • S-FMDRS immediately after, 2 months and 6 months after the treatment
  • HADS at 1 month, 2 months and 6 months after the treatment
  • DLPFC-amygdala functional connectivity
  • Amygdala BOLD response to emotional stimuli

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18-80
  • Diagnosis of functional movement disorder made by a neurologist
  • Agreement to adhere to Lifestyle Considerations throughout study duration
  • Ability of subject to understand and the willingness to sign a written informed consent document.

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Current psychosis or active suicidal ideation
  • History of epilepsy with the exception of febrile seizure
  • Patients with psychogenic non-epileptic seizure without comcomitant functional movement disorder
  • Any significant neurological disorders other than FMD including but not limited to multiple sclerosis, stroke, Parkinson s disease, space occupying brain lesion
  • Alcohol or substance use disorder
  • Patients who are on Buproprion (Wellbutrin)
  • Patients with moderate to severe cardiac disease
  • Any psychiatric, medical or social condition 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.
  • Pregnancy

Treatment and study plan

MagStim

Device

Bursts of three at 50Hz with an inter burst interval of 200 ms will be given for 190 seconds and this session will be repeated 3 times with 20 minutes between each session in one day. The set of 3 sessions will be repeated 5 times in 5 consecutive days.

Sham Comparator

Other

Sham TMS stimulation using a sham coil

Primary outcomes

  1. Change in S-FMDRS at 1 Month After Real iTBS vs Sham iTBS

    Time frame: 1 month after iTBS

    The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) measures abnormal movements in 7 body regions as well as gait and speech. Symptom severity in each body region is rated from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) and duration from 0 to 3 (0=none; 1=occasionally, 2=frequent, 3= constant). All severity and duration scores are added to yield a total score. The total score ranges from minimum 0 to maximum 68, high score representing worse outcome.

Secondary outcomes

  1. Change in S-FMDRS at 2 and 6 Months After Real iTBS vs Sham iTBS

    Time frame: 2 and 6 months after iTBS

    The Simplified Functional Movement Disorders Rating Scale (S-FMDRS) measures abnormal movements in 7 body regions as well as gait and speech. Symptom severity in each body region is rated from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe) and duration from 0 to 3 (0=none; 1=occasionally, 2=frequent, 3= constant). All severity and duration scores are added to yield a total score. The total score ranges from minimum 0 to maximum 68, high score representing worse outcome.

  2. Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS

    Time frame: At baseline and 1, 2 and 6 months after iTBS

    Hospital Anxiety and Depression Scale (HADS) is a continuous numeric scale in depression and anxiety (depression 0-21 and anxiety 0-21, higher score representing worse outcome) and the questions ask about the feeling in the past week. This was repeatedly measured at baseline, then at 1 month, 2 months and 6 months after iTBS vs sham and was compared between iTBS vs sham group.

  3. CGI at 1, 2, and 6 Months After Real iTBS vs Sham iTBS

    Time frame: 1, 2 and 6 months after iTBS

    The Clinical Global Impression (CGI) can assess patient's view of the patient's global functioning prior to and after initiating a study medication. The CGI scale of 1-7 is a measure of clinical improvement from the intervention, higher score presenting worse outcome. (1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse)

Other outcomes

  1. Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS

    Time frame: Baseline and at 1, 2 and 6 months after iTBS

    The short form (36) health survey is an indicator of health-related quality of life using 36 questions. It has eight domains; the scores are weighted sums of the questions in each domain. Scores range from 0 - 100 in each domain (lower scores = more disability, higher scores = less disability).

    • Physical Functioning (PF) - ability to perform physical activities (e.g., walking, climbing stairs)
    • Role Physical (RP) - limitations in work or daily activities due to physical health
    • Bodily Pain (BP) - intensity of pain and its impact on normal work
    • General Health (GH) - overall perception of personal health
    • Vitality (VT) - energy level and fatigue
    • Social Functioning (SF) - impact of physical or emotional health on social activities
    • Role Emotional (RE) - limitations in work or daily activities due to emotional problems
    • Mental Health (MH) - psychological distress and well-being (e.g., anxiety, depression)

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Dec 13, 2021
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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