Functional Neurosurgery - Research
Phase II Trial for Deep Brain Stimulation and Anorexia Nervosa
Thank you for your interest in our Deep Brain Stimulation (DBS) research. We have completed Phase I of the trial and are in the process of recruiting patients for our Phase II study.
In order to be considered for enrollment in this study, male or female patients must be between the ages of 20 and 60, diagnosed with Anorexia Nervosa and have a long-term pattern of continued unresponsiveness to repeated voluntary hospitalizations during their illness.
If you or a family member is interested in applying for this study please direct inquiries to email@example.com For clinicians to refer patients to the study, consultation notes can be faxed to 416-603-5298, to the attention of Dr. Nir Lipsman and Dr. Andres Lozano.
Phase II Trial for Deep Brain Stimulation and Alzheimer’s
The Advance Study is sponsored by Functional Neuromodulation Ltd.
Thank you for your interest in our deep brain stimulation (DBS) research. We have completed phase 1 of the trial and are in the process of recruiting patients for our Phase II study.
If you are interested in applying for this study please review the information below and fill out the enrolment form and fax it back to 416-603-5298.
Dr. Andres Lozano,
Professor of Neurosurgery
Toronto Western Hospital,
University of Toronto
Krembil Neuroscience Centre
Canada Research Chair in Neuroscience
|Ages Eligible for Study:||55 years to 80 years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
You will be considered a candidate for this study if:
- 55-80 years of age (inclusive)
- Probable Alzheimer's disease according to the National Institute of Aging Alzheimer's disease Association criteria.
- Must meet certain criteria on cognitive and behavioral rating scales.
- If female, subjects who are post-menopausal or surgically sterile or willing to use birth control methods for the duration of the study.
- An available caregiver willing to participate.
- Subject is living at home and likely to remain at home for the study duration.
- The subject is currently taking a stable dose of cholinesterase inhibitor (AChEI) medication for at least 60 days
- Do not meet certain criteria on cognitive and behavioral rating scales
- Current major psychiatric disorder such as schizophrenia, bipolar disorder or major depressive disorder based on psychiatric consult at screening visit
- History of head trauma in the 2 years prior to signing the consent to participate in the study
- History of brain tumor, subdural hematoma, or other clinically significant (in the judgment of the investigator) space-occupying lesion on CT or MRI
- Active psychiatric disorder
- Mental retardation
- Current alcohol or substance abuse as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
- Contraindications for PET scanning (e.g., insulin dependent diabetes)
- Contraindications for MRI scanning, including implanted metallic devices (e.g. non-MRI-safe cardiac pacemaker or neurostimulator; some artificial joints metal pins; surgical clips; or other implanted metal parts), or claustrophobia or discomfort in confined spaces.
- Abnormal lab results that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
- Abnormal cardiovascular or neurovascular disorder that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
- Unstable doses of any medication prescribed for the treatment of memory loss or Alzheimer's disease.
- Currently prescribed any non-AD medications that, in the opinion of the investigator and/or enrollment review committee, would preclude participation in the study.
- Is unable or unwilling to comply with protocol follow-up requirements.
- Has a life expectancy of < 1 year.
- Is actively enrolled in another concurrent clinical trial.
Frequently Asked Questions
If you have questions about the use of DBS for early Alzheimer’s, please read below.
1. I have a family member with early Alzheimer’s disease and I want to enroll them in the study, how do I do that?
If you know of someone who has early Alzheimer’s disease and might be interested in participating in this trial, we first need to determine if this person meets the trial entry criteria. Because it is a research study, we have strict limitations. Please download the form below and fax it back to 416-603-5298. Please be advised that only those patients who meet the trial entry criteria will be contacted. If you are deemed eligible we can arrange a more thorough appraisal and possible visit to determine candidacy and appropriateness for this study.
2. I have a family member who suffers from other memory conditions, besides Alzheimer’s, can they be enrolled in the DBS for early Alzheimer’s study?
If DBS treatment for early Alzheimer’s proves to be safe and effective, we would consider treating patients with other forms of memory disturbances. For the time being, we will have to wait until we have the results of the experimental study.
3. I would like to learn more about how DBS can improve memory, where can I learn more?
Please click here to read the media release.
4. I would like to be seen by a neurologist at Toronto Western Hospital’s Memory Clinic, how can I get an appointment?
If you would like to become a patient of Toronto Western Hospital’s Memory Clinic, you need to be referred by a physician; please contact the Memory Clinic for a referral form at 416.603.5232.
5. I want to learn more about DBS for depression and possibly enroll in a clinical trial, how can I get more information?
Please contact Karen Ng at (416) 603-5800 ext. 3304 or via email: Karenwy.firstname.lastname@example.org
6. I am a member of the media and would like to interview Dr. Lozano about his DBS work, how can I arrange an interview?
Please contact Nadia Daniell-Colarossi, Sr. Public Affairs Advisor at Krembil Neuroscience Centre - Toronto Western Hospital by phone, 416-603-5294 or email at email@example.com
7. I would like to make a donation to help fund Dr. Lozano’s deep brain stimulation for Alzheimer’s disease research, how can I make a donation?
If you are interested in making a financial donation towards Dr. Lozano’s research, please call Lauren Dzenis at the Toronto General & Western Hospital Foundation at 416.603.5800 ext 6241 or via email firstname.lastname@example.org
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