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Research Subjects Needed
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Traumatic Brain Injury (TBI) and Memory
Research subjects needed to participate in a research study of traumatic brain injury (TBI) and memory. Mild, moderate, and severe injuries welcome.

The research will involve:

•Memory testing sessions
•A one-time MRI (brain imaging) session
•A short outpatient memory rehabilitation program

Other requirements for this study are:

•You must have had a TBI at least 12 months ago.
•You must have been at least 20 at the time of your TBI.
•You must be fluent in English.
•You must be right-handed.

You will be compensated for your time and travel.

For more information, please call:

Kalika Kelkar
(617) 755-9675
Spaulding / Partners TBI Model System

This study is funded by the National Institute on Disability and Rehabilitation Research, (NIDRR), the US Department of Education.

Stroke Subjects Wanted

The Spaulding Rehabilitation Hospital is seeking patients who have suffered a stroke to participate in a clinical trial.

If you have suffered a stroke and have weakness in one hand and/or arm as a result, you may be eligible to participate in an investigational study to assess the safety and effectiveness of an implanted device* in treating patients who have reduced hand and/or arm function after stroke. The study compares electrical stimulation plus rehabilitative therapy to rehabilitative therapy alone. The Food and Drug Administration (FDA) has granted approval for this investigational study to be conducted at a number of investigational sites nationwide, including Spaulding Rehabilitation Hospital.

Description of study participation:

•An image of the brain by functional magnetic resonance imaging (fMRI) will be used to identify the region involved in function of the affected hand and/or arm. Patients must not have any conditions which could interfere with magnetic resonance imaging (such as a pacemaker or other metallic material in the body or anxiety in enclosed or tight spaces).
•Patients will be randomly assigned to one of two treatment groups. Both treatment groups will participate in six weeks of intensive rehabilitative therapy.
•Patients randomized to the study arm will undergo two surgeries. In the first surgery, a neurosurgeon will place an electrode on the layer covering the brain (the dura) over the area identified in the fMRI scan. The electrode will be connected to a pulse generator (similar to a pacemaker) implanted below the collarbone. Stimulation will be below the level of sensation (or movement) and will be administered during rehabilitation sessions only. The second surgery will be performed to remove the system approximately eight weeks after conclusion of the rehabilitation period.
•Participation in the research study will last for approximately 33 weeks after randomization to a treatment group. In addition to the six weeks of rehabilitation activities, participation will also require several visits to the study center for assessments following rehabilitation.

A partial list of requirements for this study are that:

•Patients must be at least 21 years old.
•Patients must have had a stroke four months ago or longer.
•Patients must have weakness in one hand and/or arm.

* Caution: Investigational device. Limited by Federal (or United States) law to investigational use.

For more information, please call:

Lisa Abel, Study Coordinator
(617) 726-9143
label@partners.org
Protocol # 2005-p-001780/1

For More Information: (617) 573-7000
Hearing Impaired: (800) 439-2370/TDD