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| Name | Class |
|---|---|
| St. Barnabas Medical Center | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Atkins Diet (MAD) | Experimental |
| |
| Normal Diet | No Intervention | Those patients in the normal diet (no intervention) group will also meet with the epilepsy center nutritionist to review the food diary and completion of this document, similar to those in the intervention (MAD) group. No dietary restrictions will be made in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Atkins Diet (MAD) | Other | For those in the MAD intervention group, the dietitian trains the patient and family in the preparation and management of this specialized therapy including sick-day guidelines, meal planning, carbohydrate counting and trouble-shooting. Written and verbal education including, but not limited to: recipes, education materials, sample meal plans and carbohydrate counters are provided to the patient during the initial education session. The caregiver/patient is trained in the outpatient setting and the diet is implemented at home with as much email/phone support from the dietician and ketogenic team as the patient needs to successfully maintain the diet. Medications are all changed over to the lowest carbohydrate forms to eliminate excess carbohydrate intake and all patients are started on vitamin supplements to maintain adequate nutrition. |
| Measure | Description | Time Frame |
|---|---|---|
| Neuroinflammation markers in blood | As measured by level of cytokines IL-6, TNF alpha, and C-reactive protein in blood samples | At time of surgery (approximately 3-4 weeks after randomization) |
| Metabolism | As measured by level of fasting lipid profile, acylcarnitine profile, and beta-hydroxybutyrate in blood | At time of surgery (approximately 3-4 weeks after randomization) |
| Neuroinflammation markers in brain tissue | As measured by level of cytokines, IL6, TNF alpha, and microglial activation and proliferation in brain tissue obtained during durgery | At time of surgery (approximately 3-4 weeks after randomization) |
| Levels of leptin in brain tissue | At time of surgery (approximately 3-4 weeks after randomization) | |
| Levels of adenosine in brain tissue | At time of surgery (approximately 3-4 weeks after randomization) | |
| Levels of adenosine kinase in brain tissue | At time of surgery (approximately 3-4 weeks after randomization) | |
| Levels of adenosite-1 (A1) receptors in brain tissue | At time of surgery (approximately 3-4 weeks after randomization) | |
| Levels of enzymes that synthesize glutamate and GABA | As measured in brain tissue obtained during surgery |
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Inclusion Criteria:
Patients scheduled for epilepsy surgery at New York Langone Medical Center or St Barnabas Medical Center will be eligible for enrollment.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orrin Devinsky, MD | NYU Langone Epilepsy Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Neurology and Neurosurgery at Saint Barnabas | Livingston | New Jersey | 07039 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36775798 | Derived | Leitner DF, Siu Y, Korman A, Lin Z, Kanshin E, Friedman D, Devore S, Ueberheide B, Tsirigos A, Jones DR, Wisniewski T, Devinsky O. Metabolomic, proteomic, and transcriptomic changes in adults with epilepsy on modified Atkins diet. Epilepsia. 2023 Apr;64(4):1046-1060. doi: 10.1111/epi.17540. Epub 2023 Feb 24. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| At time of surgery (approximately 3-4 weeks after randomization) |
| NYU Langone Epilepsy Center |
| New York |
| New York |
| 10016 |
| United States |