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Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Seeking Stroke Victims to Evaluate Brain Recovery after Chronic Stroke

The purpose of this study is to optimize a Magnetic Resonance compatible hand induced robotic device and MRI to identify brain recovery bio-markers that can monitor therapy and predict stroke recovery outcome in chronic stroke patients.

40 visits over 4 months
Estimated Time Commitment
Male, Female, 18-70 years
May Be Eligible
Payment up to $300
May Be Offered
MRI scan
May Be Required
 
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This project is not recruiting.

What we are studying

The purpose of the study is to develop, test, adjust, and improve new magnetic resonance imaging (MRI) and/or magnetic resonance spectroscopic imaging techniques for detection of function using our magnetic resonance systems and an investigational device that may help rehabilitation from stroke. The investigational device, called Magnetic Resonance Compatible Hand-Induced Robotic Device (MR_CHIROD), resembles regular exercise handgrips, and you will use it like you would with other exercise handgrips. The testing and improvement of magnetic resonance techniques requires multiple MR images several times using different settings used to obtain the MR image. The images are then compared to determine which of the settings under test allows the best visualization of the desired aspect of the brain.


Why it is important

Success will facilitate selection of patients and personalized treatment planning optimized to yield improvements based on MRI metrics. Specifically, this study may identify bio-markers of brain recovery that can be monitored during therapy, inform therapy adjustments, and advance our ability to predict stroke recovery outcome. For chronic stroke patients, we anticipate demonstrating that recovery is possible for a longer period of time than previously thought, including motor skill improvements beyond 6 months after a stroke event, owing to the capacity for neuroplasticity and functionally adaptive reorganization. If this research indicates continued improvement with physical therapy, then the limitations of Medicare and other insurances should be extended to assist in longer-term recovery of stroke victims, thus improving their quality of life, especially in the geriatric patient population, where stroke is most prevalent. This study may result in significant societal benefit, as they are the first step in creating new procedures for non-invasive MRI compatible hand induced robotic device. For the participants, there may be no direct benefit. However, the anticipated outcome of this study is that these investigations will lead to improved image quality and information content which may prove to be beneficial to the medical care of others in the future.


What we hope to accomplish

One-hundred, 18-70 year old, patients (≥ 6 months after stroke), will be recruited through registries of stroke survivors who have agreed to be contacted for stroke recovery and rehabilitation studies maintained at the Massachusetts General Hospital and affiliates. Twenty-four, healthy, age-matched volunteers will form a control group. Brain maps and tractography of the stroke patients will be compared to those of controls to determine any differences in plasticity.   

Principal Investigator

A. Aria Tzika, PhD

Massachusetts General Hospital

Public Profile

Entry Criteria and Anticipated Enrollment for stroke patients:


1)      Age of 18-70 years


2)      Ischemic stroke


3)      Subcortical middle cerebral artery (MCA) stroke


4)      Stroke confirmed by CT or MRI ≥ 6 months prior


5)      Stroke-induced mild to moderate contralateral hemiparesis affecting the right or left hand or foot


6)      Residual weakness ≤ 50% max force of unaffected hand or foot (i.e. significant impairment)


7)      Able to give written informed consent

Exclusion criteria: Exclusion will be implemented on the basis of a routine neurological exam and screening for contra-indicators in magnetic resonance environment, and will depend on whether EMG detects synkinetic movements during activation task versus controls. 


1)      Evidence of spasticity or joint stiffness


2)      No major spasticity while performing the motor task


3)      As defined by the NIH stroke scale questions for decreased level of consciousness (questions 1a, 1b, 1c; each >0), aphasia (question 9; score >2), or neglect (question 11; score >2)


4)      Affected sensory modalities such as pinprick, light touch, and proprioceptive


5)      Sign or history of somatosensory deficit of the right or left hand or foot


6)      Other neurological or psychiatric disease that may impact ability to comply with the protocol


7)      Deafness and/or blindness


8)      Prior cerebrovascular disease, brainstem stroke, or multiple cerebral lesions


9)      Routine MRI exclusion criteria, such as the presence of a pacemaker or cerebral aneurysm clip; metal implants or metal content in body


10)  Electrical implants such as cardiac pacemakers or perfusion pumps


11)  Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants


12)  Ferromagnetic objects such as jewelry or metal clips in clothing


13)  Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions


14)   Pregnancy

If you decide to join this research study, the following things will happen:


You will be asked to complete MRI exam sessions and the MR­ CHIROD training/gel ball exercise sessions or the MR-compatible foot-pedal device training.


The training will consist of squeezing the hand device for 60 min/d, 4×/week for 12 weeks, along with weekend trainings involving squeezing a gel exercise ball for 1 hour on the weekends. For the foot pedal device, training will consist of pushing the foot device for 60 min/d, 5x/week, for 12 weeks. The hand device will involve playing a side-scrolling game on a laptop while using the device. Imaging and neurological exam will be done before training, after 4, 8, 12 weeks during the training period and 4 weeks after the end of the training to ascertain the persistency of the observed effects. Additionally, if the subjects meet the criteria, they have the option to re-enroll in this study to perform training with other device e.g., they performed training with our hand device and would like to also perform training with our foot pedal device, and vice versa.


Project activities may include:

  • MRI scan

Estimated Time Commitment

40 visits over 4 months


For stroke patients, you will be paid up to $250 for all hospital visits and for MR_CHIROD training, plus a $50 completion bonus at the end of the study. Total payment is up to $300 for completion of the entire study.

Massachusetts General Hospital, Charlestown navy yard campus
149 13th Street, Charlestown, MA, 02129

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Travel

  • Parking available
  • Parking reimbursed
  • Accessible by public transportation
  • Local travel reimbursed
  • Out of state travel possibly reimbursed

Travel and Parking Details

Venue :  Athinoula A. Martinos Center for Biomedical Imaging, MGH 


              149 13th St, Charlestown, MA 02129      


Parking:    MGH CNY Parking Garage
                 199 13th St
                  Charlestown, MA 02129


Participating Institutions


Funding Source

  • NIH or Other Federal
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