Pathophysiology of Dystonia and Complex Regional Pain Syndrome
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|ClinicalTrials.gov Identifier: NCT03223623|
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : February 8, 2018
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.
To understand why people with CRPS develop dystonia, and if these reasons are different in people with FHD.
Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age.
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.
|Condition or disease|
|Dystonia Complex Regional Pain Syndromes|
The current exploratory study aims at detailed evaluation of pathophysiology of Complex Regional Pain Syndrome (CRPS) dystonia compared to Focal Hand Dystonia (FHD) with focus on the involvement of the parietal area.
The study will enroll patients with Focal Hand Dystonia (FHD), CRPS dystonia, CRPS without dystonia and Healthy Volunteers (HVs).
Prospective study using MRI and Physiology experiments using EMG and TMS based protocols to evaluate the differences between the groups.
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 CRPS dystonia compared to FHD, in the different conditions. We will look for changes in the BOLD signal in the parietal sensorimotor integration area.
- We will further explore the differential activation in CRPS dystonia vs CRPS without dystonia to identify any specific features inherent to patients with CRPS dystonia compared to CRPS alone.
The Physiology experiments aim to explore abnormalities and differences in the baseline motor cortical excitability between the groups and evaluated 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 CRPS dystonia and FHD.
We will also be studying the baseline Spatial and Temporal Discrimination (SDTs and TDTs), which are measures of sensory surround inhibition. TDT and SDT abnormalities have been noted to be endophenotypic of dystonia, however the comparative characteristics between FHD and CRPS dystonia are not known.
- 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 CRPS dystonia and the influence of cTBS on cSP between the groups in the involved limb.
- The TDTs/ SDTs in both the involved and uninvolved limbs in FHD and CRPS dystonia compared to HVs.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Investigations of Pathophysiology of Dystonia and Complex Regional Pain Syndrome|
|Actual Study Start Date :||December 12, 2017|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
U.S. FDA Resources
Focal Hand Dystonia (FHD)
Focal Hand Dystonia (FHD)
CRPS without dystoni
CRPS without dystonia
- The evaluation using fMRI will be performed under 3 conditions; 1. Rest 2. Voluntary activity 3. Motor imagery task. [ Time Frame: Ongoing ]
- TMS outcomes (continuous): differential influences of PMv and IPL on motor cortical excitability, changes after cTBS of dIPL, changes in the SI measures post TBS in FHD. [ Time Frame: Ongoing ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223623
|Contact: Elaine P Considine, R.N.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Shabbir Hussain I Merchant, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|