Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05155059
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2021-12-09
Brief Title:
Non-invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase II Trial of Non-Invasive Intermittent Theta Burst Stimulation of the Dorsolateral Prefrontal Cortex in Functional Movement Disorders
Status:
RECRUITING
Status Verified Date:
2024-09-13
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 000642-N | None | None | None |