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Trial record 1 of 3 for:    dystonia | CRPS
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Pathophysiology of Dystonia and Complex Regional Pain Syndrome

This study is currently recruiting participants.
Verified October 18, 2017 by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT03223623
First Posted: July 21, 2017
Last Update Posted: November 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
July 19, 2017
July 21, 2017
November 21, 2017
November 24, 2017
January 31, 2018   (Final data collection date for primary outcome measure)
The evaluation using fMRI will be performed under 3 conditions; 1. Rest 2. Voluntary activity 3. Motor imagery task. [ Time Frame: Ongoing ]
Same as current
Complete list of historical versions of study NCT03223623 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Pathophysiology of Dystonia and Complex Regional Pain Syndrome
Investigations of Pathophysiology of Dystonia and Complex Regional Pain Syndrome

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.

Objective:

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.

Study population:

The study will enroll patients with Focal Hand Dystonia (FHD), CRPS dystonia, CRPS without dystonia 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 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.

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 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.
Observational
Observational Model: Case-Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The study will enroll patients with Focal Hand Dystonia (FHD), CRPS dystonia, CRPS without dystonia and Healthy Volunteers (HVs).
  • Dystonia
  • Complex Regional Pain Syndromes
Not Provided
  • Focal Hand Dystonia (FHD)
    Focal Hand Dystonia (FHD)
  • CRPS dystonia
    CRPS dystonia
  • CRPS without dystoni
    CRPS without dystonia
  • Healthy Volunteer
    Healthy Volunteers

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 31, 2019
January 31, 2018   (Final data collection date for primary outcome measure)
  • INCLUSION CRITERIA:
  • Age between 18 - 70 years.
  • Able to give informed consent.
  • Able to comply with all study procedures.
  • Subjects must be willing to abstain from alcohol for at least 48 hours prior to the study.
  • Adult patients with an established diagnosis of focal hand dystonia.
  • Healthy volunteers will be healthy subjects without neurological or psychiatric disorders established by history and physical/neurological examination.
  • Adult CRPS patients, diagnosed based on the Budapest Clinical diagnostic criteria by an experienced Neurologist, with the presence of dystonia involving at least one hand.
  • Adult CRPS patients, diagnosed based on the Budapest Clinical diagnostic criteria by an experienced Neurologist, without the presence of dystonia in any limbs.
  • Patients receiving botulinum toxin injections will be evaluated after 3 months since their last injection.
  • All participants must be able to obtain an MRI (No contraindications per MRI safety checklist) which will be part of the initial evaluation.

EXCLUSION CRITERIA:

  • Self-reported consumption of >14 alcoholic drinks/week for a man and >7 alcoholic drinks/week for a woman.
  • Patients on daily chronic opioid or benzodiazepine use.
  • Patients treated with anticholinergics, who are not willing and/or unable to withhold taking them for 1 week prior and for the duration of the study participation.
  • Patients taking opioids and/or benzodiazepines on an as needed basis, who are not willing and/or unable to withhold taking them for 1 week or time interval equivalent to 5 half-lives (whichever is shorter) prior to study participation and for the days during study participation.
  • Abnormal findings on neurological examination, except diagnosis of interest (FHD, CRPS with/without dystonia in patients.
  • History of or current brain tumor, stroke, head trauma with loss of consciousness, epilepsy or seizures.
  • Past or present medical history of (a) neurological disorders, such as stroke, movement disorders (other than dystonia in the patient group), ataxias, myopathies, myasthenia gravis, demyelinating diseases, alcoholism, drug dependence; (B) ventricular arrhythmias, renal and hepatic insufficiency, vascular headache, or carcinoid syndrome.
  • Subjects with Baclofen pumps and/or neuro stimulators for pain.
  • Current episode of major depression or any major psychiatric illness. Note: SSRI use is not exclusionary.
  • Pregnant or breastfeeding women. Aside from history obtained at the screening, pregnancy status in women with childbearing potential is also established by urine pregnancy testing no more than 24 hours before each MRI and TMS sessions.
  • Subjects who have contraindications to MRI:

    • You have metal in your body which would make having an MRI scan unsafe, such as pacemakers, stimulators, pumps, aneurysm clips, metallic prostheses, artificial heart valves, cochlear implants or shrapnel fragments, or if you were a welder or metal worker, since you may small metal fragments in the eye.
    • You are uncomfortable in small closed spaces (you have claustrophobia) so that you would feel uncomfortable in the MRI machine.
    • You are not able to lie comfortably on your back for approximately 2 hours.
  • Subjects who have contra-indications for TMS

    • You have a pacemaker, implanted pump, stimulator, cochlear implant or metal objects inside the eye or skull.
    • You have hearing loss.
  • You are pregnant. NIH employees and/or staff.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
United States
 
 
NCT03223623
170126
17-N-0126
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: Shabbir Hussain I Merchant, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
October 18, 2017