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Current Studies

These are our current research studies, including a project summary, dates of existence, principle investigators, and related resources:

Projects Listing

Hemorrhage / Cerebral Amyloid Angiopathy Studies

Ischemic Studies

Other Neurology Studies

Hemorrhage / Cerebral Amyloid Angiopathy Studies

GOCHA

Genetic Risks for Medication-Related Hemorrhagic Stroke
NIH / NINDS

Principal Investigator: Dr. Jonathan Rosand
Co-Investigators: Dr. Steven M. Greenberg, Dr. Anand Viswanathan, Dr. Joshua Goldstein
Enrollment: Amy Halpin 617.643.2782
End Date: July 31, 2013

Summary: The goal of this multi-center study is to examine potential genetic risk factors for intracerebral hemorrhage in patients taking anticoagulant medication.

The Role of Advanced CAA in Alzheimer's Dementia

NIH-NIA National Institute on Aging/ADRC

Principal Investigator: Dr. Anand Viswanathan
Co-Investigators: Dr. Steven M. Greenberg and Dr. Jonathan Rosand
Enrollment: Amy Halpin 617.643.2782
End Date: March 31, 2014

Summary: The goal of this study is to determine how advanced CAA affects the clinical and cognitive profile of AD subjects and to use Neuroimaging to identify white matter lesions and other possible tissue injury markers potentially responsible for its impact.

Ischemic Studies

DIAS 4

Funded By: H. Lundbeck A/S

Principal Investigator: Lee H. Schwamm, M.D.
Co-Investigator: Pending
Enrollment: Matthew Siket, M.D.
Start Date: November 2010 (MGH screening)
End Date: Ongoing

Summary: A randomized, double-blind, parallel-group, placebo-controlled phase III study to evaluate the efficacy and safety of desmoteplase in subjects with acute ischemic stroke-DIAS-USA. The primary objective is to find out if the study drug, desmoteplase, can help people with ischemic stroke when given 3 to 9 hours after symptoms begin. The secondary objective is to find out if desmoteplase is safe to take without causing too many side effects.

Inclusion/Exclusion Criteria: Coming soon

GASROS

Genes Associated with Stroke Risk and Outcomes Study

Principal Investigator: Karen L. Furie, M.D.
Enrollment: Mikaela Larson 617.643.3952
Start Date: 2001
End Date: October 1, 2011

Summary: Genes appear to contribute to the risk of having a stroke and may affect recovery from stroke. We are enrolling subjects with a history of ischemic stroke or TIA to examine the genetic determinants of stroke risk and outcome. We contribute DNA to the NINDS Human Genetics Resource Center.

Abstract: Not yet available

IRIS

Insulin Resistance Intervention after Stroke Trial

Principal Investigator: Karen L. Furie, M.D.
Co-Investigators: none
Enrollment: Sara DeGregorio
Start Date: December 14, 2004
End Date: July 1, 2012

Summary: The Insulin Resistance Intervention after Stroke (IRIS) trial is a randomized clinical trial that will test the effectiveness of a new approach to preventing stroke and heart attack among patients with a recent ischemic stroke or TIA. The new approach targets insulin resistance, a newly-recognized cause of atherosclerosis.

Abstract: Not yet available

NIH funded Multi-departmental Stroke Program Project Grant

Principal Investigator: Michael Moskowitz, M.D.

Summary:Goal is to better understand the molecular mechanisms that underlie ischemic stroke.

Online Publications

  • None available

MR RESCUE

Mechanical Retrieval and Recanalization of Stroke Clot Using Embolectomy

Funded By: The National Institute of Neurological Disorders and Stroke (NINDS)

Principal Investigator: Lee H. Schwamm, M.D., FAHA
Co-Investigator: Pending
Enrollment: Matthew Siket, M.D.
Start Date: November 2010 (MGH screening)
End Date: Ongoing

Summary: Successful conduct of the trial will evaluate whether use of multimodal CT or multimodal MRI is a rational and appropriate selection criterion for endovascular therapy for acute ischemic stroke. A positive trial will suggest substantial clinical benefit from embolectomy therapy in the group of patients with a penumbral imaging pattern, and permit informed design of definitive phase 3 trial(s) of endovascular embolectomy. Please contact us for more information.

Inclusion/Exclusion Criteria: Coming soon

MR WITNESS

A Phase IIa Safety Study of Intravenous Thrombolysis with Alteplase in MRI-Selected Patients

Funded By: The National Institute of Neurological Disorders and Stroke (NINDS)

Principal Investigators: Lee H. Schwamm, M.D., FAHA and Ona Wu, PhD
Co-Investigator: Edip M. Gurol, M.D.
Enrollment: Tijy Thankachan 617.643.3956
Start Date: May 2011
End Date: June 2014

Summary: The goal of this study is to determine the safety of extending intravenous alteplase treatment to acute stoke subjects with unclear onsets who are evaluated within 24 h from last known well and who can be treated within 4.5 h from "symptom discovery" who present with an MRI pattern consistent with early stage stroke. MR WITNESS is a multi-center, open-label, single-arm, Phase IIa safety study. The subject population of the study will be 80 male and female adults (18-80 year-old inclusive).

NEST-3

NeuroThera® Efficacy and Safety Trial - 3 (NEST-3)

Funded By: Photothera, Inc.

Principal Investigator: Aneesh B. Singhal, M.D.
Co-Investigators: Lee H. Schwamm, M.D., FAHA, Leigh R. Hochberg, M.D., Ph.D., Scott Silverman, M.D., Natalia S. Rost, M.D., Joshua Goldstein, M.D. and Megan Aleardi, MPH
Enrollment: maleardi@partners.org
Start Date: October, 2011
End Date: Ongoing

Summary: The purpose of this pivotal study is to demonstrate safety and efficacy of transcranial laser therapy (TLT) with the NeuroThera® Laser System in the treatment of subjects diagnosed with acute ischemic stroke. The initiation of the TLT procedure must be feasible for each subject between 4.5 and 24 hours of stroke onset.

Inclusion Criteria

  • Age 40–80 years
  • Not a candidate for thrombolysis (IV or IA)
  • Initiation of the TLT procedure between 4.5 and 24 hours after stroke onset
  • Baseline NIHSS score range: 7-17
  • Baseline mRS 0-2
  • Negative pregnancy test in females of childbearing potential

Exclusion Criteria

  • Evidence of an intracranial, subdural, or subarachnoid hemorrhage
  • Acute ischemic strokes located exclusively in the brainstem or cerebellum
  • Small deep infarctions (lacunar stroke)
  • Massive hemispheric stroke (>1/3 of the MCA territory)
  • Seizure at stroke onset or within the 7 days prior to stroke onset

Full Inclusion/Exclusion criteria and other details: click here

Novel MRI Technology for Delineating the Ischemic Penumbra

Funded By: NINDS R01 NS-051412 (Singhal, PI)

Principal Investigator: Aneesh B. Singhal, M.D.
Co-Investigators: William Copen, M.D., W. Taylor Kimberly, M.D., PhD, Ona Wu, PhD, Ovidiu Adronesi, PhD, Zhe Sun, PhD, Elissa McIntosh, and Megan Aleardi, MPH
Enrollment: maleardi@partners.org
Start Date: 2011
End Date: Ongoing

Summary: The primary objective of this research is to develop non-gadolinium MRI techniques that will distinguish irreversibly damaged brain tissue ("core"), from ischemic tissue that is at risk for infarction ("penumbra") in patients with acute ischemic stroke. Consenting subjects will undergo 3-T MRI within 48 hours after onset of ischemic stroke or cerebral vasospasm. A follow-up MRI will be obtained between day 4-120.

Inclusion Criteria

  • Age greater than or equal to 18 years
  • Acute ischemic stroke >5 cc as confirmed on CT or MRI
    OR
    Subarachnoid hemorrhage with suspected or confirmed cerebral vasospasm

Exclusion Criteria

  • Contraindication to MRI (pacemaker or other metallic implant, foreign metal object in body, claustrophobia, inability to lie flat for 60 minutes)
  • Pre-menopausal women with a positive pregnancy test blood test performed at admission
  • Medically unstable to travel for MRI

Optional "Oxygen Probe" MRI Sequence includes two additional exclusions:

  • Severe and active chronic lung disease (FEV1 <1.0, or oxygen dependent at baseline).
  • Baseline peripheral oxygen saturation level less than 92%.

Pfizer Stroke Recovery Trial

Funded By: Pfizer, Inc.

Principal Investigator: Aneesh B. Singhal, M.D.
Co-Investigators: Randie Black-Schaffer, M.D., Scott Silverman, M.D., David Caplan, M.D., Nicole Mazawi, M.D., Annie Yuan, N.P., Quin Wang, M.D., and Megan Aleardi, MPH
Enrollment: maleardi@partners.org
Start Date: October, 2011
End Date: Ongoing

Summary: The purpose this study is to evaluate the safety and tolerability of PF-03049423 following multiple dose administration to subjects with ischemic stroke. The study will also evaluate the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following 90 days of therapy. The study will also explore the relationship between PF-03049423 concentration and blood pressure.

Inclusion Criteria

  • Age 18-85 years
  • Ischemic stroke onset within 72 hours
  • Supratentorial ischemic stroke involving the cortex
  • Baseline NIHSS of 6-20 inclusive
  • NIHSS item 5 score 1-4 (i.e. stroke involving upper extremity)
  • No previous stroke in the 90 days prior to enrollment

Exclusion Criteria

  • Women of child bearing potential
  • NIHSS item 1a score ≥ 2 points

Other Links: View this study on ClinicalTrials.gov

SPOTRIAS

Specialized Program of Translational Research in Acute Stroke

Principal Investigators: Karen L. Furie, M.D., Lee H. Schwamm, M.D., FAHA and Ona Wu, PhD
Enrollment: Brenda Thornell 617.724.1538
Start Date: July, 2011
End Date: June, 2014

Summary: The overall goal of SPOTRIAS is to allow researchers to enhance and initiate translational research that ultimately will benefit individuals with stroke.

For more information, visit our SPOTRIAS main page or one of the following related pages:

Stroke Database / Research Registry

Principal Investigator: Karen L. Furie, M.D.
Co-Investigator: MGH Stroke Service
Enrollment: Rebecca Green
Start Date: 1999
End Date: Ongoing

Summary: The stroke database is a prospective observational study. The inclusion criteria is any patient admitted to the MGH or BWH with TIA (transient ischemic attack); or ischemic stroke. There are no exclusion criteria. The purpose is to assess the efficacy of acute stroke interventions with respect to functional outcome and mortality in patients with acute ischemic stroke, to determine the efficacy and cost-effectiveness of stroke treatments for acute ischemic, and to create a database of stroke patients for use in ongoing research on stroke diagnosis, treatment and outcomes.

Other Neurology Studies

BrainGate

Funded By: Rehabilitation Research & Development Service, Department of Veterans Affairs National Institutes of Health (NIDCD, NICHD/NCMRR, NINDS, NIBIB)

Principal Investigator: Leigh R. Hochberg, M.D., Ph.D.
Co-Investigators: Sydney Cash, M.D., Ph.D. and Merit Cudkowicz, M.D., M.Sc.
Contact: clinicaltrials@braingate2.org
Start Date: 2009
End Date: Ongoing

Summary: Patients who have spinal cord injury, brainstem stroke, muscular dystrophy, or motor neuron disease such as amyotrophic lateral sclerosis (ALS) and have limited use of their hands are needed for an FDA regulated research study to evaluate a new technology which may allow an individual with these injuries or neurologic disorders to control a computer cursor by thought. The study is invasive and requires surgery. You must live within 2 hours of Boston, Massachusetts to participate. The study requires a commitment of 13 months. If you would like to learn more about this study, please contact Dr. Leigh Hochberg at (617) 726-4218.

Other Links:

Abstract and Inclusion/Exclusion Criteria: Not listed

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In the News

The MGH Neurology Department placed 4th in US News Neurology / NeuroSurgery rankings for 2014-15.

Educational Video

Still from the Stroke Evaluation simulation

This video simulation of an Emergency stroke evaluation illustrates the care of patients with acute stroke by the MGH Acute Stroke team.