Ignite Creation Date:
2024-05-06 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03223623
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2017-07-19
Brief Title:
Pathophysiology of Focal Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigations of Pathophysiology of Focal Hand Dystonia
Status:
COMPLETED
Status Verified Date:
2022-05-25
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
Little is known about the problems in brain function in focal hand dystonia FHD or complex regional pain syndrome CRPS dystonia It is unclear why some CRPS patients develop dystonia but others do not Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD
Objectives
To understand why people with CRPS develop dystonia and if these reasons are different in people with FHD
Eligibility
Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age
Design
Participants will be screened with physical exam neurological exam and medical history They may give a urine sample and will answer questions
Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days
Participants will have MRI scans They will lie on a table that slides in and out of a scanner that takes pictures of their brain They will do small tasks or be asked to imagine things during the scanning
Participants will have transcranial magnetic stimulation TMS sessions for a few hours with breaks A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse This affects brain activity Participants may do small tasks during TMS
Participants will have the electrical activity of their muscles measured during TMS sessions Small sticky pads will be attached to their hands and arms
Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers They will also be asked to feel small plastic domes with ridges that may cause discomfort
Little is known about the problems in brain function in focal hand dystonia FHD or complex regional pain syndrome CRPS dystonia It is unclear why some CRPS patients develop dystonia but others do not Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD
Objectives
To understand why people with CRPS develop dystonia and if these reasons are different in people with FHD
Eligibility
Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age
Design
Participants will be screened with physical exam neurological exam and medical history They may give a urine sample and will answer questions
Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days
Participants will have MRI scans They will lie on a table that slides in and out of a scanner that takes pictures of their brain They will do small tasks or be asked to imagine things during the scanning
Participants will have transcranial magnetic stimulation TMS sessions for a few hours with breaks A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse This affects brain activity Participants may do small tasks during TMS
Participants will have the electrical activity of their muscles measured during TMS sessions Small sticky pads will be attached to their hands and arms
Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers They will also be asked to feel small plastic domes with ridges that may cause discomfort
Detailed Description:
Objective detailed evaluation of pathophysiology of Focal Hand Dystonia FHD with focus on the involvement of the parietal area and to investigate differences in cortical mapping in the sensory and motor cortices between FHD and healthy volunteers
Study population The study will enroll patients with FHD and Healthy Volunteers HVs
Design Prospective study using MRI and Physiology experiments using EMG and TMS based protocols to evaluate the differences between the groups
Outcome measures The evaluation using fMRI will be performed under 3 conditions 1 Rest 2 Voluntary activity 3 Motor imagery task
Outcome measures fMRI based
We will explore the differences in BOLD signal in the parietal lobe in FHD compared to HVs in the different conditions We will look for changes in the BOLD signal in the parietal sensorimotor integration area
We will use vascular occupancy imaging VASO to explore differences of detailed cortical mapping of neural structures between FHD and healthy volunteers
The Physiology experiments aim to explore abnormalities and differences in the baseline motor cortical excitability between the groups and evaluate the influence of continuous Theta Burst Stimulation cTBS on these measures We will study the influence of cTBS on the phenomenon Cortical Silent Period cSP in FHD
We will also be studying the baseline Spatial and Temporal Discrimination SDTs and TDTs which are measures of sensory surround inhibition and have been noted to be endophenotypic of dystonia
Physiology outcomes
Baseline differential influences of PMv and IPL on motor cortical excitability and changes after cTBS of dIPL
Baseline cortical Silent Period cSP in the involved and uninvolved limb in FHD and the influence of cTBS on cSP in the involved limb
The TDTs SDTs in both the involved and uninvolved limbs in FHD compared to HVs
Study population The study will enroll patients with FHD and Healthy Volunteers HVs
Design Prospective study using MRI and Physiology experiments using EMG and TMS based protocols to evaluate the differences between the groups
Outcome measures The evaluation using fMRI will be performed under 3 conditions 1 Rest 2 Voluntary activity 3 Motor imagery task
Outcome measures fMRI based
We will explore the differences in BOLD signal in the parietal lobe in FHD compared to HVs in the different conditions We will look for changes in the BOLD signal in the parietal sensorimotor integration area
We will use vascular occupancy imaging VASO to explore differences of detailed cortical mapping of neural structures between FHD and healthy volunteers
The Physiology experiments aim to explore abnormalities and differences in the baseline motor cortical excitability between the groups and evaluate the influence of continuous Theta Burst Stimulation cTBS on these measures We will study the influence of cTBS on the phenomenon Cortical Silent Period cSP in FHD
We will also be studying the baseline Spatial and Temporal Discrimination SDTs and TDTs which are measures of sensory surround inhibition and have been noted to be endophenotypic of dystonia
Physiology outcomes
Baseline differential influences of PMv and IPL on motor cortical excitability and changes after cTBS of dIPL
Baseline cortical Silent Period cSP in the involved and uninvolved limb in FHD and the influence of cTBS on cSP in the involved limb
The TDTs SDTs in both the involved and uninvolved limbs in FHD compared to HVs
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 |
|---|---|---|---|
| 17-N-0126 | None | None | None |