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Research and Clinical Trials

Clinical Trials Offer Hope & Guide Treatment Plans

Medical advances in the diagnosis and treatment of Parkinson's disease (PD) offer hope to patients and families while also guiding the treatment plans developed by our team of PD specialists. That's why the Parkinson's Disease and Movement Disorders Center at BIDMC actively participates in multi-center clinical trials evaluating new treatments for PD.

  • We are members of the Parkinson Study Group, a national consortium of PD centers that carries out multi-center clinical trials of new medications for the treatment of PD.
  • We participate in several other leading-edge clinical research studies of new medications for PD.
  • We are actively participating in a National Institutes of Health initiative to identify therapies that may slow the progression of PD.
  • We are a National Parkinson Foundation Center of Excellence, which provides us with access to funding for clinical research, community outreach, and educational projects.

Current Research Studies Available

Gait Analysis in Neurological Disease

The purpose of this study is to learn more about walking problems in people with Parkinson's disease and similar conditions. The study will involve participating in a single study visit with an optional follow up at Beth Israel Deaconess Medical Center. Researchers will collect a neurological history and exam from participants and measure walking using a special mat equipped with electronic sensors. Parking is compensated and $25 is paid for the completion of each study visit.

Inclusion Criteria:

Patients with Parkinson's disease and similar conditions and healthy volunteers between the ages of 18 and 85.

Exclusion Criteria:

Participants should be otherwise healthy, not recently hospitalized, and without heart or lung conditions that would prevent walking for ten minutes.

Contact: Christine Ashton, cashton@bidmc.harvard.edu or 617-667-4746

 

Phase 2A Safety & Biomarker Study: EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects

EPI-589 is an agent that may enhance mitochondrial function and reduce oxidative stress. The primary objective of this study is to evaluate the effects of EPI-589 safety as assessed by occurrence of drug-related serious adverse events in subjects with PD. Subjects will participate in a 30-day run-in phase to establish biomarker and clinical baseline measurements. EPI-589 will then be administered for all subjects for up to three months, unless discontinued for safety or tolerability issues.

Inclusion Criteria

  • Idiopathic Subjects
    • diagnosed with PD within five years of enrollment
    • age 40 to 75
    • must not yet require symptomatic medications for PD and not expected to require such treatment before the end of the study
  • Genetic Subtype Subjects
    • confirmed diagnosis of PD plus a genetic diagnosis consistent with PD
    • age 21 to 75
    • stable medication regimen of PD drugs for 30 days prior to enrollment

Exclusion Criteria

  • History of brain surgery
  • History of stroke
  • MoCA score of < 24
  • Participation within past three months and for duration of study in a trial of a device, drug or other therapy for PD
  • Idiopathic subjects: use of any MAO inhibitors, amantadine or other drugs prescribed for treatment of PD symptoms

Contact: Althea Silver, asilver2@bidmc.harvard.edu or 617-667-9885

 

Transcranial Stimulation for Essential Tremor

The purpose of this study is to learn more about brain changes in people with essential tremor using noninvasive brain stimulation (transcranial magnetic stimulation) and brain imaging. The study will involve participating in several study visits, taking place at BIDMC and one visit at the Martinos Center for Biomedical Imaging at the Massachusetts General Hospital.

Study visits include a neurological history and exam, MRI exam, measuring tremor using noninvasive sensors and applying noninvasive brain stimulation. Parking will be compensated. Healthy control subjects will receive a maximum of $100 for the completion of all study visits and subjects with tremor will receive a maximum of $200 for completion of all visits.

Inclusion Criteria

  • Patients with essential tremor and healthy volunteers between the ages of 18 and 75.
  • Individuals who are not pregnant and do not have medical devices or metal in the body that are not MRI-compatible.

Contact: Christine Ashton, cashton@bidmc.harvard.edu or 617-667-4746

 

Dystonia Coalition

The Dystonia Coalition is an international collaboration of medical researchers and patient advocacy groups with a mission to advance the pace of clinical and translational research in the dystonias to find better treatments and a cure. To participate you must be at least 18 years old and be diagnosed with one of the following primary dystonias:

  • Focal dystonia, including cranial dystonia/Meige Syndrome (including blepharospasm)
  • Jaw or tongue dystonia
  • Laryngeal dystonia (including spasmodic dysphonia) with diagnosis confirmed by nasolaryngoscopy
  • Cervical dystonia (spasmodic torticollis)
  • Limb dystonia (including writer’s cramp and musician’s dystonia)
  • Segmental dystonia
  • Generalized dystonia
  • Hemi-dystonia

Your last injection of botulinum toxin should be at least two months prior to study visit. You must not have evidence of a secondary cause for dystonia. During the study visit, you will answer questions about your medical and family history, have a neurological exam that will be videotaped, and donate about four tablespoons of blood. The entire visit takes about 60 to 90 minutes. Parking will be compensated.

Contact: Christine Ashton, cashton@bidmc.harvard.edu or 617-667-4746

 

A Randomized, Double-Blind, Placebo-Controlled Trial of Urate-Elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson’s Disease

Subjects are enrolled in a 27-month study (24-month study period with 3-months of washout) to determine whether oral inosine dosed to moderately elevate serum urate levels over two years slows clinical decline in early Parkinson’s disease. This study also aims to determine the safety and tolerability of urate-elevating inosine treatment as well as the long-term effects of inosine on the need for initiating dopaminergic medication changes, vital signs and orthostatic changes, and quality of life and functional disability measures.

Inclusion criteria:

  • Diagnosis of idiopathic Parkinson’s disease made within three years of screening.
  • Not taking dopaminergic therapy within three months of enrollment.

Exclusion criteria:

  1. Atypical parkinsonism.
  2. DaTScan without evidence of dopamine deficiency in the brain.
  3. History of myocardial infarction or stroke.
  4. Use of the following medications within 60 days of Baseline visit: levodopa, dopamine agonists, amantadine, trihexyphenidyl, benztropine.
  5. Use of the following medications/OTC treatments within 30 days prior to Baseline: inosine, allopurinol, probenecid, more than 50 IU of vitamin E daily, or more than 300 mg of vitamin C daily (standard multivitamin permissible), reserpine, methylphenidate, amphetamines, cinnarizine, monoamine oxidase-A inhibitors, neuroleptics or other dopamine blocking drugs.

Contact: Althea Silver – 617-667-9885, asilver2@bidmc.harvard.edu

 

Contact Information

Althea Silver, MPH, BSN, RN
Department of Neurology
Beth Israel Deaconess Medical Center
Shapiro 809D
330 Brookline Ave
Boston, MA 02215
617-667-9885
PDResearch@bidmc.harvard.edu

Am I Eligible?

For questions and to determine your eligibility in any of our studies, please call Althea Silver, RN, BSN, MPH, at 617-667-9885.


There is no cost to you for study visits or study-related care.

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