Trial Outcomes & Findings for Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders (NCT NCT05155059)

Last Updated: 2026-08-12

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

Target enrollment

25 participants

Primary outcome timeframe

1 month after iTBS

Results posted on

2026-08-12

Participant Flow

Study participants were recruited between May 2022 and March 2025 at National Institutes of Health Clinical Center located in Bethesda Maryland.

Twenty-five participants consented to participate; one failed screening, and one was withdrawn prior to randomization due to newly identified exclusionary finding.

Participant milestones

Participant milestones
Measure	Treatment Active TMS stimulation using an active TMS coil 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.	Control Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
Overall Study STARTED	11	12
Overall Study COMPLETED	11	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 1 month after iTBS

Outcome measures

Outcome measures
Measure	Treatment n=11 Participants Active TMS stimulation using an active TMS coil 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.	Control n=12 Participants Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
Change in S-FMDRS at 1 Month After Real iTBS vs Sham iTBS	-48.08 % change of scores on a scale Standard Error 13.30	-39.47 % change of scores on a scale Standard Error 11.40

SECONDARY outcome

Timeframe: 2 and 6 months after iTBS

Population: The number of participants analyzed for 2 months and 6 months is different from the numbers in the participant flow due to missing data.

Outcome measures

Outcome measures
Measure	Treatment n=11 Participants Active TMS stimulation using an active TMS coil 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.	Control n=12 Participants Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
Change in S-FMDRS at 2 and 6 Months After Real iTBS vs Sham iTBS Change in S-FMDRS at 2 months	-48.04 % change of scores on a scale Standard Error 13.30	-43.43 % change of scores on a scale Standard Error 11.62
Change in S-FMDRS at 2 and 6 Months After Real iTBS vs Sham iTBS Change in S-FMDRS at 6 months	-45.33 % change of scores on a scale Standard Error 13.30	-40.76 % change of scores on a scale Standard Error 11.62

SECONDARY outcome

Timeframe: At baseline and 1, 2 and 6 months after iTBS

Population: The number of participants analyzed for 2 months and 6 months is different from the numbers in the participant flow due to missing data.

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.

Outcome measures

Outcome measures
Measure	Treatment n=11 Participants Active TMS stimulation using an active TMS coil 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.	Control n=12 Participants Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Anxiety_1 month	7.73 scores on a scale Standard Deviation 5.62	6.08 scores on a scale Standard Deviation 2.61
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Anxiety_baseline	8.82 scores on a scale Standard Deviation 5.4	7.67 scores on a scale Standard Deviation 3.37
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Anxiety_2 months	9.18 scores on a scale Standard Deviation 6.87	5.45 scores on a scale Standard Deviation 2.98
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Anxiety_6months	9.18 scores on a scale Standard Deviation 6.38	7.27 scores on a scale Standard Deviation 4.76
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Depression_baseline	7.55 scores on a scale Standard Deviation 4.95	3.83 scores on a scale Standard Deviation 2.72
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Depression_1 month	6.91 scores on a scale Standard Deviation 4.76	2.92 scores on a scale Standard Deviation 1.93
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Depression_2 months	8.27 scores on a scale Standard Deviation 5.48	3.45 scores on a scale Standard Deviation 3.05
Change in Hospital Anxiety and Depression Scale (HADS) at 1, 2 and 6 Months After Real iTBS vs Sham iTBS Depression_6 months	8.18 scores on a scale Standard Deviation 5.98	4.64 scores on a scale Standard Deviation 2.98

SECONDARY outcome

Timeframe: 1, 2 and 6 months after iTBS

Population: The number of participants analyzed for 2 months and 6 months is different from the numbers in the participant flow due to missing data.

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)

Outcome measures

Outcome measures
Measure	Treatment n=11 Participants Active TMS stimulation using an active TMS coil 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.	Control n=12 Participants Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
CGI at 1, 2, and 6 Months After Real iTBS vs Sham iTBS 6 months	3.44 scores on a scale Standard Error 0.57	3.06 scores on a scale Standard Error 0.52
CGI at 1, 2, and 6 Months After Real iTBS vs Sham iTBS 1 month	3.62 scores on a scale Standard Error 0.57	2.99 scores on a scale Standard Error 0.51
CGI at 1, 2, and 6 Months After Real iTBS vs Sham iTBS 2 months	3.80 scores on a scale Standard Error 0.57	3.16 scores on a scale Standard Error 0.51

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and at 1, 2 and 6 months after iTBS

Population: Number of participants analyzed are different from the numbers in the participant flow due to missing data

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)

Outcome measures

Outcome measures
Measure	Treatment n=11 Participants Active TMS stimulation using an active TMS coil 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.	Control n=12 Participants Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS PF_Baseline	57.5 scores on a scale Standard Deviation 25.64	57.86 scores on a scale Standard Deviation 27.52
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS PF_1 month	53.89 scores on a scale Standard Deviation 29.24	56.42 scores on a scale Standard Deviation 30.82
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS PF_2 months	52.78 scores on a scale Standard Deviation 27.4	62.86 scores on a scale Standard Deviation 39.14
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS PF_6 months	55.56 scores on a scale Standard Deviation 27.78	65.71 scores on a scale Standard Deviation 34.21
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RP_Baseline	47.92 scores on a scale Standard Deviation 28.14	39.29 scores on a scale Standard Deviation 30.77
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RP_1 month	45.14 scores on a scale Standard Deviation 31.06	52.78 scores on a scale Standard Deviation 32.64
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RP_2 months	34.72 scores on a scale Standard Deviation 30.8	61.61 scores on a scale Standard Deviation 43.22
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RP_6 months	42.36 scores on a scale Standard Deviation 34.2	60.71 scores on a scale Standard Deviation 37.97
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS BP_Baseline	36.25 scores on a scale Standard Deviation 19.35	59.64 scores on a scale Standard Deviation 19.76
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS BP_1 month	41.39 scores on a scale Standard Deviation 20.08	65.83 scores on a scale Standard Deviation 25.83
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS BP_2 months	37.5 scores on a scale Standard Deviation 23.52	61.07 scores on a scale Standard Deviation 37.99
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS BP_6 months	35 scores on a scale Standard Deviation 26.87	70.36 scores on a scale Standard Deviation 26.28
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS GH_Baseline	50.83 scores on a scale Standard Deviation 18.28	52.86 scores on a scale Standard Deviation 17.53
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS GH_1 month	62.78 scores on a scale Standard Deviation 20.93	59.44 scores on a scale Standard Deviation 20.07
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS GH_2 months	57.22 scores on a scale Standard Deviation 20.93	67.14 scores on a scale Standard Deviation 27.21
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS GH_6 months	53.33 scores on a scale Standard Deviation 27.95	62.86 scores on a scale Standard Deviation 26.12
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS VT_Baseline	42.08 scores on a scale Standard Deviation 26.24	39.29 scores on a scale Standard Deviation 8.35
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS VT_1 month	36.11 scores on a scale Standard Deviation 23.23	50.32 scores on a scale Standard Deviation 17.19
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS VT_2 months	31.94 scores on a scale Standard Deviation 25.43	51.61 scores on a scale Standard Deviation 18.38
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS VT_6 months	33.19 scores on a scale Standard Deviation 22.56	48.57 scores on a scale Standard Deviation 11.28
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS SF_Baseline	43.75 scores on a scale Standard Deviation 30.36	60.71 scores on a scale Standard Deviation 32.62
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS SF_1 month	51.39 scores on a scale Standard Deviation 35.6	75 scores on a scale Standard Deviation 18.75
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS SF_2 months	43.06 scores on a scale Standard Deviation 25.85	75 scores on a scale Standard Deviation 31.46
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS SF_6 months	41.67 scores on a scale Standard Deviation 29.32	80.36 scores on a scale Standard Deviation 18.9
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RE_Baseline	69.44 scores on a scale Standard Deviation 28.22	72.62 scores on a scale Standard Deviation 19.67
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RE_1 month	61.11 scores on a scale Standard Deviation 29.17	83.33 scores on a scale Standard Deviation 19.54
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RE_2 months	54.63 scores on a scale Standard Deviation 30.93	76.19 scores on a scale Standard Deviation 33.13
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS RE_6 months	56.48 scores on a scale Standard Deviation 33.28	80.95 scores on a scale Standard Deviation 27.52
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS MH_Baseline	63.33 scores on a scale Standard Deviation 22.28	60.14 scores on a scale Standard Deviation 19.07
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS MH_1 month	66.56 scores on a scale Standard Deviation 17.74	75.33 scores on a scale Standard Deviation 7.75
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS MH_2 months	57.22 scores on a scale Standard Deviation 20.54	76.57 scores on a scale Standard Deviation 13.36
Change in SF-36 at 1, 2, and 6 Months After Real iTBS vs Sham iTBS MH_6 months	58.56 scores on a scale Standard Deviation 21.57	74.71 scores on a scale Standard Deviation 13.61

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=11 participants at risk Active TMS stimulation using an active TMS coil 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.	Control n=12 participants at risk Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil
Nervous system disorders Headache	27.3% 3/11 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.	0.00% 0/12 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.
Nervous system disorders Pain	9.1% 1/11 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.	16.7% 2/12 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.
Nervous system disorders Syncope	9.1% 1/11 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.	0.00% 0/12 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.
Nervous system disorders Involuntary movements	9.1% 1/11 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.	8.3% 1/12 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.
Ear and labyrinth disorders Vertigo	18.2% 2/11 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.	0.00% 0/12 • Adverse events were collected from enrollment until end of follow-up, up to 6 months. Adverse events were solicited over the period of 6 months or for the duration of the study for the individual participant.

Additional Information

Director, Movement Disorders Clinic

NINDS Parkinson's and Movement Disorders Clinic

Phone: 301-443-7888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment n=11 Participants Active TMS stimulation using an active TMS coil 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.	Control n=12 Participants Sham TMS stimulation using a sham coil Sham Comparator: Sham TMS stimulation using a sham coil	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=1 Participants	12 Participants n=1 Participants	22 Participants n=1 Participants
Age, Categorical >=65 years	1 Participants n=1 Participants	0 Participants n=1 Participants	1 Participants n=1 Participants
Sex: Female, Male Female	9 Participants n=1 Participants	8 Participants n=1 Participants	17 Participants n=1 Participants
Sex: Female, Male Male	2 Participants n=1 Participants	4 Participants n=1 Participants	6 Participants n=1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Asian	1 Participants n=1 Participants	1 Participants n=1 Participants	2 Participants n=1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Race (NIH/OMB) Black or African American	3 Participants n=1 Participants	0 Participants n=1 Participants	3 Participants n=1 Participants
Race (NIH/OMB) White	7 Participants n=1 Participants	10 Participants n=1 Participants	17 Participants n=1 Participants
Race (NIH/OMB) More than one race	0 Participants n=1 Participants	1 Participants n=1 Participants	1 Participants n=1 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=1 Participants	0 Participants n=1 Participants	0 Participants n=1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=1 Participants	10 Participants n=1 Participants	19 Participants n=1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=1 Participants	2 Participants n=1 Participants	4 Participants n=1 Participants
S-FMDRS	18.82 scores on a scale STANDARD_DEVIATION 9.03 • n=1 Participants	13.25 scores on a scale STANDARD_DEVIATION 7.92 • n=1 Participants	15.91 scores on a scale STANDARD_DEVIATION 8.75 • n=1 Participants