An interventional study of MagStim and Sham Comparator in Functional Movement Disorder, sponsored by National Institutes of Health Clinical Center (CC). Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Treatment
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.
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:
89 studies on the registry are indexed under Conversion Disorder; 34 are open to participants now.
This study's enrollment of 25 is below the median of 38 across 51 interventional studies indexed under Conversion Disorder.
Browse Conversion Disorder studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sham TMS stimulation using a sham coil
Other: Sham Comparator
Active TMS stimulation using an active TMS coil
Device: MagStim
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 TMS stimulation using a sham coil
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.
Time frame: 1 month after iTBS
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.
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
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.
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
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)
Time frame: 1, 2 and 6 months after iTBS
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham 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). 1. Physical Functioning (PF) - ability to perform physical activities (e.g., walking, climbing stairs) 2. Role Physical (RP) - limitations in work or daily activities due to physical health 3. Bodily Pain (BP) - intensity of pain and its impact on normal work 4. General Health (GH) - overall perception of personal health 5. Vitality (VT) - energy level and fatigue 6. Social Functioning (SF) - impact of physical or emotional health on social activities 7. Role Emotional (RE) - limitations in work or daily activities due to emotional problems 8. Mental Health (MH) - psychological distress and well-being (e.g., anxiety, depression)
Time frame: Baseline and at 1, 2 and 6 months after iTBS
Study participants were recruited between May 2022 and March 2025 at National Institutes of Health Clinical Center located in Bethesda Maryland.
| Milestone | Treatment | Control |
|---|---|---|
| Started | 11 | 12 |
| Completed | 11 | 12 |
| Not completed | 0 | 0 |
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.
| % change of scores on a scale | Treatment | Control |
|---|---|---|
| Change in S-FMDRS at 1 Month After Real iTBS vs Sham iTBS | -48.08 ± 13.30 | -39.47 ± 11.40 |
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.
| % change of scores on a scale | Treatment | Control |
|---|---|---|
| Change in S-FMDRS at 2 months | -48.04 ± 13.30 | -43.43 ± 11.62 |
| Change in S-FMDRS at 6 months | -45.33 ± 13.30 | -40.76 ± 11.62 |
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.
| scores on a scale | Treatment | Control |
|---|---|---|
| Anxiety_baseline | 8.82 ± 5.4 | 7.67 ± 3.37 |
| Anxiety_1 month | 7.73 ± 5.62 | 6.08 ± 2.61 |
| Anxiety_2 months | 9.18 ± 6.87 | 5.45 ± 2.98 |
| Anxiety_6months | 9.18 ± 6.38 | 7.27 ± 4.76 |
| Depression_baseline | 7.55 ± 4.95 | 3.83 ± 2.72 |
| Depression_1 month | 6.91 ± 4.76 | 2.92 ± 1.93 |
| Depression_2 months | 8.27 ± 5.48 | 3.45 ± 3.05 |
| Depression_6 months | 8.18 ± 5.98 | 4.64 ± 2.98 |
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)
| scores on a scale | Treatment | Control |
|---|---|---|
| 1 month | 3.62 ± 0.57 | 2.99 ± 0.51 |
| 2 months | 3.80 ± 0.57 | 3.16 ± 0.51 |
| 6 months | 3.44 ± 0.57 | 3.06 ± 0.52 |
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). 1. Physical Functioning (PF) - ability to perform physical activities (e.g., walking, climbing stairs) 2. Role Physical (RP) - limitations in work or daily activities due to physical health 3. Bodily Pain (BP) - intensity of pain and its impact on normal work 4. General Health (GH) - overall perception of personal health 5. Vitality (VT) - energy level and fatigue 6. Social Functioning (SF) - impact of physical or emotional health on social activities 7. Role Emotional (RE) - limitations in work or daily activities due to emotional problems 8. Mental Health (MH) - psychological distress and well-being (e.g., anxiety, depression)
| scores on a scale | Treatment | Control |
|---|---|---|
| PF_Baseline | 57.5 ± 25.64 | 57.86 ± 27.52 |
| PF_1 month | 53.89 ± 29.24 | 56.42 ± 30.82 |
| PF_2 months | 52.78 ± 27.4 | 62.86 ± 39.14 |
| PF_6 months | 55.56 ± 27.78 | 65.71 ± 34.21 |
| RP_Baseline | 47.92 ± 28.14 | 39.29 ± 30.77 |
| RP_1 month | 45.14 ± 31.06 | 52.78 ± 32.64 |
| RP_2 months | 34.72 ± 30.8 | 61.61 ± 43.22 |
| RP_6 months | 42.36 ± 34.2 | 60.71 ± 37.97 |
| BP_Baseline | 36.25 ± 19.35 | 59.64 ± 19.76 |
| BP_1 month | 41.39 ± 20.08 | 65.83 ± 25.83 |
| BP_2 months | 37.5 ± 23.52 | 61.07 ± 37.99 |
| BP_6 months | 35 ± 26.87 | 70.36 ± 26.28 |
| GH_Baseline | 50.83 ± 18.28 | 52.86 ± 17.53 |
| GH_1 month | 62.78 ± 20.93 | 59.44 ± 20.07 |
| GH_2 months | 57.22 ± 20.93 | 67.14 ± 27.21 |
| GH_6 months | 53.33 ± 27.95 | 62.86 ± 26.12 |
| VT_Baseline | 42.08 ± 26.24 | 39.29 ± 8.35 |
| VT_1 month | 36.11 ± 23.23 | 50.32 ± 17.19 |
| VT_2 months | 31.94 ± 25.43 | 51.61 ± 18.38 |
| VT_6 months | 33.19 ± 22.56 | 48.57 ± 11.28 |
| SF_Baseline | 43.75 ± 30.36 | 60.71 ± 32.62 |
| SF_1 month | 51.39 ± 35.6 | 75 ± 18.75 |
| SF_2 months | 43.06 ± 25.85 | 75 ± 31.46 |
| SF_6 months | 41.67 ± 29.32 | 80.36 ± 18.9 |
| RE_Baseline | 69.44 ± 28.22 | 72.62 ± 19.67 |
| RE_1 month | 61.11 ± 29.17 | 83.33 ± 19.54 |
| RE_2 months | 54.63 ± 30.93 | 76.19 ± 33.13 |
| RE_6 months | 56.48 ± 33.28 | 80.95 ± 27.52 |
| MH_Baseline | 63.33 ± 22.28 | 60.14 ± 19.07 |
| MH_1 month | 66.56 ± 17.74 | 75.33 ± 7.75 |
| MH_2 months | 57.22 ± 20.54 | 76.57 ± 13.36 |
| MH_6 months | 58.56 ± 21.57 | 74.71 ± 13.61 |
Collected over Adverse events were collected from enrollment until end of follow-up, up to 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/11 (0%) | 0/11 (0%) | 8/11 (72.7%) |
| Control | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) |
| Event | Treatment | Control |
|---|---|---|
| HeadacheNervous system disorders | 3/11 | 0/12 |
| VertigoEar and labyrinth disorders | 2/11 | 0/12 |
| PainNervous system disorders | 1/11 | 2/12 |
| SyncopeNervous system disorders | 1/11 | 0/12 |
| Involuntary movementsNervous system disorders | 1/11 | 1/12 |
| Age, Categorical(Participants) | Treatment | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 12 | 22 |
| >=65 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 9 | 8 | 17 |
| Male | 2 | 4 | 6 |
| Race (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 0 | 3 |
| White | 7 | 10 | 17 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 9 | 10 | 19 |
| Unknown or Not Reported | 2 | 2 | 4 |
| S-FMDRS(scores on a scale) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 18.82 ± 9.03 | 13.25 ± 7.92 | 15.91 ± 8.75 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — All collected IPD during the trial can be shared after de-identification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: At the time of publication. For 2 years after the publication
Access criteria: IPD can be shared with researchers who provide methodologically sound proposal for meta-analysis or any other scientific analysis. Requests should be directed to the study PI who will review requests. Only de-identified data will be shared for scientific purposes.
Ran from May 2022 to primary completion in Apr 2025, 35 months.
Results were first posted in Aug 2026, 1 year 3 months after primary completion.
Of 34 interventional studies with no phase under Conversion Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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