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Page 1
FDA Perspectives on the Regulation of Neuromodulation Devices.
Marjenin T, Scott P, Bajaj A, Bansal T, Berne B, Bowsher K, Costello A, Doucet J, Franca E, Ghosh C, Govindarajan A, Gutowski S, Gwinn K, Hinckley S, Keegan E, Lee H, Mathews B, Misra S, Patel S, Tang X, Heetderks W, Hoffmann M, Pena C. Marjenin T, et al. Among authors: gwinn k. Neuromodulation. 2020 Jan;23(1):3-9. doi: 10.1111/ner.13085. Neuromodulation. 2020. PMID: 31965667 Review.
Patient-Centered Identification of Meaningful Regulatory Endpoints for Medical Devices to Treat Parkinson's Disease.
Benz HL, Caldwell B, Ruiz JP, Saha A, Ho M, Christopher S, Bardot D, Sheehan M, Donnelly A, McLaughlin L, Mange B, Hauber AB, Gwinn K, Heetderks WJ, Sheldon M. Benz HL, et al. Among authors: gwinn k. MDM Policy Pract. 2021 Jul 2;6(1):23814683211021380. doi: 10.1177/23814683211021380. eCollection 2021 Jan-Jun. MDM Policy Pract. 2021. PMID: 34277950 Free PMC article.
Parkinson's Patients' Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study.
Hauber B, Mange B, Zhou M, Chaudhuri S, Benz HL, Caldwell B, Ruiz JP, Saha A, Ho M, Christopher S, Bardot D, Sheehan M, Donnelly A, McLaughlin L, Gwinn K, Lo A, Sheldon M. Hauber B, et al. Among authors: gwinn k. MDM Policy Pract. 2021 Jan 18;6(1):2381468320978407. doi: 10.1177/2381468320978407. eCollection 2021 Jan-Jun. MDM Policy Pract. 2021. PMID: 33521289 Free PMC article.
Nutritional interventions in primary mitochondrial disorders: Developing an evidence base.
Camp KM, Krotoski D, Parisi MA, Gwinn KA, Cohen BH, Cox CS, Enns GM, Falk MJ, Goldstein AC, Gopal-Srivastava R, Gorman GS, Hersh SP, Hirano M, Hoffman FA, Karaa A, MacLeod EL, McFarland R, Mohan C, Mulberg AE, Odenkirchen JC, Parikh S, Rutherford PJ, Suggs-Anderson SK, Tang WH, Vockley J, Wolfe LA, Yannicelli S, Yeske PE, Coates PM. Camp KM, et al. Among authors: gwinn ka. Mol Genet Metab. 2016 Nov;119(3):187-206. doi: 10.1016/j.ymgme.2016.09.002. Epub 2016 Sep 20. Mol Genet Metab. 2016. PMID: 27665271 Free PMC article. Review.
The BioFIND study: Characteristics of a clinically typical Parkinson's disease biomarker cohort.
Kang UJ, Goldman JG, Alcalay RN, Xie T, Tuite P, Henchcliffe C, Hogarth P, Amara AW, Frank S, Rudolph A, Casaceli C, Andrews H, Gwinn K, Sutherland M, Kopil C, Vincent L, Frasier M. Kang UJ, et al. Among authors: gwinn k. Mov Disord. 2016 Jun;31(6):924-32. doi: 10.1002/mds.26613. Epub 2016 Apr 26. Mov Disord. 2016. PMID: 27113479 Free PMC article.
The NINDS Parkinson's disease biomarkers program.
Rosenthal LS, Drake D, Alcalay RN, Babcock D, Bowman FD, Chen-Plotkin A, Dawson TM, Dewey RB Jr, German DC, Huang X, Landin B, McAuliffe M, Petyuk VA, Scherzer CR, Hillaire-Clarke CS, Sieber BA, Sutherland M, Tarn C, West A, Vaillancourt D, Zhang J, Gwinn K; PDBP consortium. Rosenthal LS, et al. Among authors: gwinn k. Mov Disord. 2016 Jun;31(6):915-23. doi: 10.1002/mds.26438. Epub 2015 Oct 7. Mov Disord. 2016. PMID: 26442452 Free PMC article.
Cerebrospinal fluid, plasma, and saliva in the BioFIND study: Relationships among biomarkers and Parkinson's disease Features.
Goldman JG, Andrews H, Amara A, Naito A, Alcalay RN, Shaw LM, Taylor P, Xie T, Tuite P, Henchcliffe C, Hogarth P, Frank S, Saint-Hilaire MH, Frasier M, Arnedo V, Reimer AN, Sutherland M, Swanson-Fischer C, Gwinn K; Fox Investigation of New Biomarker Discovery; Kang UJ. Goldman JG, et al. Among authors: gwinn k. Mov Disord. 2018 Feb;33(2):282-288. doi: 10.1002/mds.27232. Epub 2017 Dec 4. Mov Disord. 2018. PMID: 29205509 Free PMC article.
Diagnosis of Parkinson's disease on the basis of clinical and genetic classification: a population-based modelling study.
Nalls MA, McLean CY, Rick J, Eberly S, Hutten SJ, Gwinn K, Sutherland M, Martinez M, Heutink P, Williams NM, Hardy J, Gasser T, Brice A, Price TR, Nicolas A, Keller MF, Molony C, Gibbs JR, Chen-Plotkin A, Suh E, Letson C, Fiandaca MS, Mapstone M, Federoff HJ, Noyce AJ, Morris H, Van Deerlin VM, Weintraub D, Zabetian C, Hernandez DG, Lesage S, Mullins M, Conley ED, Northover CA, Frasier M, Marek K, Day-Williams AG, Stone DJ, Ioannidis JP, Singleton AB; Parkinson's Disease Biomarkers Program and Parkinson's Progression Marker Initiative investigators. Nalls MA, et al. Among authors: gwinn k. Lancet Neurol. 2015 Oct;14(10):1002-9. doi: 10.1016/S1474-4422(15)00178-7. Epub 2015 Aug 10. Lancet Neurol. 2015. PMID: 26271532 Free PMC article.
Parkinson's disease biomarkers: perspective from the NINDS Parkinson's Disease Biomarkers Program.
Gwinn K, David KK, Swanson-Fischer C, Albin R, Hillaire-Clarke CS, Sieber BA, Lungu C, Bowman FD, Alcalay RN, Babcock D, Dawson TM, Dewey RB Jr, Foroud T, German D, Huang X, Petyuk V, Potashkin JA, Saunders-Pullman R, Sutherland M, Walt DR, West AB, Zhang J, Chen-Plotkin A, Scherzer CR, Vaillancourt DE, Rosenthal LS. Gwinn K, et al. Biomark Med. 2017 May;11(6):451-473. doi: 10.2217/bmm-2016-0370. Epub 2017 Jun 23. Biomark Med. 2017. PMID: 28644039 Free PMC article.
84 results