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

Primary Purpose

Functional Movement Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MagStim
Sham Comparator
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Movement Disorder focused on measuring Functional Movement Disorders, Transcranial Magnetic Stimulation (TMS), iTBS, Repetitive Transcranial Magnetic Stimulation, Neuroimaging, Conversion Disorder

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

Sham TMS stimulation using a sham coil

Active TMS stimulation using an active TMS coil

Outcomes

Primary Outcome Measures

S-FMDRS
Short version of Functional Movement Disorder Rating Scale

Secondary Outcome Measures

S-FMDRS
Short version of Functional Movement Disorder Rating Scale
SF-36
Health related quality of life
CGI
Clinical Global impression - scale of 1-7 to measure clinical improvement from the intervention

Full Information

First Posted
December 9, 2021
Last Updated
October 21, 2023
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT05155059
Brief Title
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
Official Title
Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 20, 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
July 1, 2031 (Anticipated)
Study Completion Date
July 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Movement Disorder
Keywords
Functional Movement Disorders, Transcranial Magnetic Stimulation (TMS), iTBS, Repetitive Transcranial Magnetic Stimulation, Neuroimaging, Conversion Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham TMS stimulation using a sham coil
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Active TMS stimulation using an active TMS coil
Intervention Type
Device
Intervention Name(s)
MagStim
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Comparator
Intervention Description
Sham TMS stimulation using a sham coil
Primary Outcome Measure Information:
Title
S-FMDRS
Description
Short version of Functional Movement Disorder Rating Scale
Time Frame
1 month after iTBS
Secondary Outcome Measure Information:
Title
S-FMDRS
Description
Short version of Functional Movement Disorder Rating Scale
Time Frame
2 and 6 months after iTBS
Title
SF-36
Description
Health related quality of life
Time Frame
1, 2 and 6 months after iTBS
Title
CGI
Description
Clinical Global impression - scale of 1-7 to measure clinical improvement from the intervention
Time Frame
1, 2 and 6 months after iTBS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyun Joo Cho, M.D.
Phone
(301) 402-9336
Email
hyunjoo.cho@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Joo Cho, M.D.
Organizational Affiliation
National Institute of Neurological Disorders and Stroke (NINDS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY8664111010
Email
prpl@cc.nih.gov

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
.All collected IPD during the trial can be shared after de-identification.
IPD Sharing Time Frame
For 2 years after the publication
IPD Sharing 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.
Citations:
PubMed Identifier
34203993
Citation
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.
Results Reference
background
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000642-N.html
Description
NIH Clinical Center Detailed Web Page

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

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