Functional Movement DisorderNCT05155059
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
A study testing MagStim in people with Functional Movement Disorder, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Movement Disorder
- What is being tested?
- MagStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2022to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Phase II Trial of 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.
Read more
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.
Read the detailed description
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
- Conditions
- Functional Movement Disorder
- Being tested
- MagStim, Sham Comparator
- Keywords
- Functional Movement Disorders, Transcranial Magnetic Stimulation (TMS), iTBS, Repetitive Transcranial Magnetic Stimulation, Neuroimaging, Conversion Disorder
- Medical subject headings
- Conversion Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagStimDevice
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 ComparatorOther
Sham TMS stimulation using a sham coil
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Sham TMS stimulation using a sham coil Receives: Other: Sham Comparator |
| Treatment | Experimental | Active TMS stimulation using an active TMS coil Receives: Device: MagStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in S-FMDRS at 1 Month After Real iTBS vs Sham 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.
Measured: 1 month after iTBS
Secondary outcomes (3)
Change in S-FMDRS at 2 and 6 Months After Real iTBS vs Sham 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.
Measured: 2 and 6 months after iTBS
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham 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.
Measured: At baseline and 1, 2 and 6 months after iTBS
CGI at 1, 2, and 6 Months After Real iTBS vs Sham 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)
Measured: 1, 2 and 6 months after iTBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start6 May 2022
- Primary completion25 Apr 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional Movement DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra J Ehrlich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155059
- Sponsor's protocol ID
- 10000642
- Other IDs
- 000642-N
- Status last verified
- Jul 2026
- First submitted
- 9 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD during the trial can be shared after de-identification.
Publications
Spagnolo PA, Parker J, Horovitz S, Hallett M. Corticolimbic Modulation via Intermittent Theta Burst Stimulation as a Novel Treatment for Functional Movement Disorder: A Proof-of-Concept Study. Brain Sci. 2021 Jun 15;11(6):791. doi: 10.3390/brainsci11060791.
PubMed 34203993
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
- ClinicalTrials.gov ID
- NCT05155059
- Acronym / sponsor ID
- 10000642
- Conditions
- Functional Movement Disorder
- Keywords
- Functional Movement Disorders, Transcranial Magnetic Stimulation (TMS), iTBS, Repetitive Transcranial Magnetic Stimulation, Neuroimaging, Conversion Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 6 May 2022 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 13 Dec 2021 (actual)
- Results
- Posted 12 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Sham ComparatorSham TMS stimulation using a sham coil |
| Treatment | Experimental | Device: MagStimActive TMS stimulation using an active TMS coil |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagStimBursts 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. | Device | Treatment |
| Sham ComparatorSham TMS stimulation using a sham coil | Other | Control |
Primary outcome
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.
3 secondary outcomes
Change in S-FMDRS at 2 and 6 Months After Real iTBS vs Sham iTBS
Time frame: 2 and 6 months after iTBS
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
CGI at 1, 2, and 6 Months After Real iTBS vs Sham iTBS
Time frame: 1, 2 and 6 months after iTBS
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34203993Spagnolo PA, Parker J, Horovitz S, Hallett M. Corticolimbic Modulation via Intermittent Theta Burst Stimulation as a Novel Treatment for Functional Movement Disorder: A Proof-of-Concept Study. Brain Sci. 2021 Jun 15;11(6):791. doi: 10.3390/brainsci11060791.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD during the trial can be shared after de-identification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra J Ehrlich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagStim in people with Functional Movement Disorder, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in S-FMDRS at 1 Month After Real iTBS vs Sham iTBS (time frame: 1 month after iTBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05155059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.