Phase
Condition
Dyskinesias
Multiple System Atrophy
Healthy Volunteers
Treatment
C11-SY08
Clinical Study ID
Ages 50-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- General Inclusion criteria, all subjects must:
Age 50-80
Be able to provide written informed consent or assent
Be able to read, speak and understand English (The investigators do not havethe resources necessary to properly study non-English speaking patients in thisstudy, given that translation and validation of the assessment tools would benecessary)
Be willing and able to participate in one PET/MRI scanning session
Additional Inclusion criteria for PD patients, subjects must:
Have an existing diagnosis of idiopathic PD, using consensus criteria
Stable medications for at least 30 days
Hoehn and Yahr stage I-IV
A study partner who can answer questions pertaining to daily functioning
Additional Inclusion criteria for MSA patients, subjects must:
Have an existing diagnosis of MSA, using consensus criteria
Stable medications for at least 30 days
MSAp or MSAc
A study partner who can answer questions pertaining to daily functioning
Additional Inclusion criteria for DLB patients, subjects must:
Have an existing diagnosis of probable DLB, using consensus criteria
Stable medications for at least 30 days
Clinical Dementia Rating Scale (CDR) < 0.5
A study partner who can answer questions pertaining to daily functioning
Exclusion
Exclusion Criteria:
- General Exclusion Criteria (All Subjects)
History of vascular risk factors (e.g. hypertension, hyperlipidemia), if notwell-controlled
Major psychiatric disease (e.g.schizophrenia)
History of stroke
Focal brain lesions on MRI scans
History of other major illnesses including, but not limited to, major kidney orliver problems or significant neurological illness
Recent surgery that is deemed major by our reviewing physician or nursepractitioner within the past 6 months
History of head trauma (as defined as having any insults to the brain that mayhave resulted from an external mechanical force, such as rapid acceleration ordeceleration, impact, blast waves, or penetration by a projectile)
Impaired elimination (as defined as having problems with urination) unlessbeing managed
Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed)
Any present substance abuse including drug/alcohol abuse
Inability to lie flat on camera bed for up to 90 min
Pregnancy or breastfeeding
Metallic foreign bodies that would be affected by the MRI magnet, or fear ofenclosed spaces likely to make the subject unable to undergo an MRI scan
Recent exposure to radiation (i.e., PET from other research) that, whencombined with this study, would be above the allowable limits (50milliSieverts)
General MR and PET safety exclusion criteria listed below
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,artificial hearts, valves with steel parts, metal fragments, shrapnel, metallictattoos anywhere on the body, tattoos near the eye, steel implants, ferromagneticobjects such as jewelry or metal clips in clothing
Electrical implants such as cardiac pacemakers or perfusion pumps
Pre-existing medical conditions including a likelihood of developing seizures orclaustrophobic reactions, and any greater than normal potential for cardiac arrest
Is unable to lie comfortably on a bed inside a PET camera with their head in thefield of view for 60 to 90 minutes as assessed by physical examination and medicalhistory (e.g. back pain, arthritis)
Pregnancy: A negative serum pregnancy test is required on the day of the PETprocedure in women of child bearing potential
Body weight of > 300 lbs (weight limit of the MRI table)
Breast feeding mothers
Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan
An abnormal result on the modified Allen's test on both hands
Raynaud syndrome
Bleeding disorder
Use of anticoagulants such as Coumadin, Plavix or Lovenox
An allergy to Lidocaine
Study Design
Connect with a study center
MGH
Charlestown 4932819, Massachusetts 6254926 02129-2020
United StatesActive - Recruiting

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