Understanding the Mechanism(s) of Action on the Modified Atkins Diet for Epilepsy: Human Brain Tissues
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Epilepsy |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/31/2019 |
| Start Date: | June 2014 |
| End Date: | December 2019 |
| Contact: | Orrin Devinsky, MD |
| Email: | Od4@nyu.edu |
| Phone: | (646) 558-0801 |
The purpose of this study is to better define the potential molecular and anti-inflammatory
changes induced by the modified Atkins diet in the brains of patients with treatment
resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to
compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20
subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks
prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher
carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects
in this study to compare serologic and brain tissue specimens. Approximately five (5)
subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5)
subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue
specimens will be obtained at the time of surgery and will be compared. The goal of this
study is to identify whether or not there are changes in neuroinflammation or
neuroexcitability in the human brain induced by the modified Atkins diet.
changes induced by the modified Atkins diet in the brains of patients with treatment
resistant epilepsy. The investigators plan to enroll 30 subjects overall in this study to
compare serologic and brain tissue specimens. At NYU, investigators plan to enroll 20
subjects; an estimated ten (10) subjects will consume a modified Atkins diet for 3-4 weeks
prior to surgery and an estimated ten (10) subjects will consume a non-modified, higher
carbohydrate diet. Investigators at Saint Barnabas Medical Center plan to enroll 10 subjects
in this study to compare serologic and brain tissue specimens. Approximately five (5)
subjects will consume a modified Atkins diet for 3-4 weeks prior to surgery and five (5)
subjects will consume a non-modified, higher carbohydrate diet. Blood and brain tissue
specimens will be obtained at the time of surgery and will be compared. The goal of this
study is to identify whether or not there are changes in neuroinflammation or
neuroexcitability in the human brain induced by the modified Atkins diet.
Inclusion Criteria:
Patients scheduled for epilepsy surgery at New York Langone Medical Center or St Barnabas
Medical Center will be eligible for enrollment.
- Patient is at least 18 years of age
- Patient is willing to participate by complying with the modified Atkins diet 3 - 4
weeks prior to surgery and maintain a thorough food diary (Intervention study group)
or to continue their usual diet and maintain a thorough food diary (Nonintervention
study group)
- Patient/ his/her parent, caregiver, or health care proxy is willing and able to
provide consent or assent
Exclusion Criteria:
- Patients under the age of 18 will be excluded
- Patients in whom a two-stage surgery is planned without any resection of brain tissue
during the initial craniotomy
- Patients unwilling to comply with modified Atkins diet 3 -4 weeks prior to surgery or
unwilling to maintain a thorough food diary will be excluded.
- Patients who are currently on an Atkins or Low Glycemic Index Diet will not be
eligible for inclusion in the nonintervention group.
We found this trial at
2
sites
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Livingston, New Jersey 07039
Phone: 973-322-7425
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