Clinical Trials

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Clinical Trials

PENS NPH Shunting Trial

Logo PENS s.webp

The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.


ClinicalTrials.gov Identifier: NCT05081128


Associated Publications

  • S. Wang, A. Carass, S.F. Maroufi, J. Hua, J.L. Prince, M.G. Luciano, and on behalf of the PENS investigators, "Methodological Analysis of the PENS Trial: An Automatic Pipeline for Measuring Corpus Callosum Arching", Hydrocephalus 2026 World Congress, São Paulo, Brazil, July 31 – August 3, 2026.
  • S. Wang, A. Carass, S.F. Maroufi, J. Hua, J.L. Prince, M.G. Luciano, and on behalf of the PENS investigators, "Longitudinal Changes in Periventricular Lesion Volume are Associated with Ventricular Morphology Changes in Normal Pressure Hydrocephalus of the PENS Trial", Hydrocephalus 2026 World Congress, São Paulo, Brazil, July 31 – August 3, 2026.
  • S. Wang, A. Carass, S.F. Maroufi, J. Hua, J.L. Prince, M.G. Luciano, and on behalf of the PENS investigators, "Methodological Analysis of the PENS Trial: An Automatic Pipeline for Calculating Evan’s Index and Callosal Angle for NPH", Hydrocephalus 2026 World Congress, São Paulo, Brazil, July 31 – August 3, 2026.
  • S. Wang, A. Carass, S.F. Maroufi, J. Hua, J.L. Prince, M.G. Luciano, and on behalf of the PENS investigators, "Mitigating Valve Artifacts in Post-Shunt Surgery MRI of the PENS Trial Using a 3D Diffusion Model", Hydrocephalus 2026 World Congress, São Paulo, Brazil, July 31 – August 3, 2026.
  • S. Wang, S. Wei, S.W. Remedios, J. Zhang, B. E. Dewey, A.M. Blitz, M.G. Luciano, A. Carass, and J.L. Prince, "VAID: Valve artifact inpainting for normal pressure hydrocephalus from a 3D MRI diffusion model", 23rd IEEE International Symposium on Biomedical Imaging (ISBI 2026), London, UK, April 8–11, 2026. DOI: "VAID: Valve artifact inpainting for normal pressure hydrocephalus from a 3D MRI diffusion model"
  • M.G. Luciano, M.A. Williams, M.G. Hamilton, H.L. Katzen, N.A. Dasher, A. Moghekar, J. Hua, J. Malm, A. Eklund, N.A. Abel, A.M. Raslan, B.D. Elder, J.J. Savage, D.L. Barrow, K. Shahlaie, H. Jensen, T.J. Zwimpfer, J. Wollett, D.F. Hanley, and R. Holubkov, for the PENS Trial Investigators and the Adult Hydrocephalus Clinical Research Network, "A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus", N Engl J Med, 393(22):2198-2209, 2025. DOI: "A Randomized Trial of Shunting for Idiopathic Normal-Pressure Hydrocephalus"


TREATMS

Logo TREAT.webp

The TRaditional versus Early Aggressive Therapy for multiple sclerosis (MS) (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.


ClinicalTrials.gov Identifier: NCT03500328


Associated Publications

  • M.F.A. Chaudhary, S.W. Remedios, K.M. Bartz, S.P. Hays, L. Zuo, C. Koch, S.D. Cassard, S. Wei, S.D. Newsome, E.M. Mowry, B.E. Dewey, J.L. Prince, and A. Carass, "Sample Structure, Refine Contrast: Zero-Shot MR Image Harmonization with a Phase-Preserving Diffusion Prior", Simulation and Synthesis in Medical Imaging (SASHIMI 2026) in conjunction with the 29th International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI 2026), Strasbourg, France, September 27–October 1, 2026. (PDF)
  • S.P. Hays, L. Zuo, M.F.A. Chaudhary, K.M. Bartz, S.W. Remedios, J. Zhang, J. Zhuo, M. Bilgel, S. Saidha, C. Koch, S.D. Cassard, E.M. Mowry, S.D. Newsome, J.L. Prince, B.E. Dewey, and A. Carass, "Harmonizing MR Images Across 100+ Scanners: Multi-site Validation with Traveling Subjects and Real-world Protocols", Medical Imaging with Deep Learning (MIDL 2026), Taipei, Taiwan, July 8–10, 2026. arXiv: "Harmonizing MR Images Across 100+ Scanners: Multi-site Validation with Traveling Subjects and Real-world Protocols" (OpenReview)   HACA3+ Code
  • S.P. Hays, J. Zhang, S.W. Remedios, K.M. Bartz, M. Salami, C. Hinds, S.D. Cassard, C. Koch, A. Fishman, A. Carass, E.M. Mowry, S.D. Newsome, J.L. Prince, and B.E. Dewey, "The Impact of Site Variability on Volumetric Analysis in a Multi-Site MRI Dataset: A Case for Image Harmonization", 11th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), San Diego, CA, February 5–7, 2026.
  • J. Zhang, L. Zuo, B.E. Dewey, S.W. Remedios, Y. Liu, S.P. Hays, D.L. Pham, E.M. Mowry, S.D. Newsome, P.A. Calabresi, A. Carass, and J.L. Prince, "UNISELF: A Unified Network with Instance Normalization and Self-Ensembled Lesion Fusion for Multiple Sclerosis Lesion Segmentation", Medical Image Analysis, 103954, 2026. DOI: "UNISELF: A Unified Network with Instance Normalization and Self-Ensembled Lesion Fusion for Multiple Sclerosis Lesion Segmentation" arXiv: "UNISELF: A Unified Network with Instance Normalization and Self-Ensembled Lesion Fusion for Multiple Sclerosis Lesion Segmentation"
  • J. Zhang, C. Rivas, B.E. Dewey, S. Wei, H. Zhang, S.W. Remedios, S.P. Hays, S. Wang, L. Zuo, E.M. Mowry, S.D. Newsome, S. Saidha, P.A. Calabresi, J.L. Prince, and A. Carass, "Automated Unique Lesion Tracking (AULTRA): A Framework for Longitudinal Lesion-wise Morphometric Analysis in Multiple Sclerosis", Radiological Sociey of North America (RSNA 2025), Chicago, IL, November 30 – December 4, 2025.
  • E.M. Mowry, P. Qian, W. Meador, S. Lynch, R. Narayan, A. Borazanci, D. Robertson, S. Qureshi, J. Graves, J. Silversteen, M. Esch, L. Tornes, C. Riley, M. Kaisey, N. Sicotte, S. Pawate, T. Gyang, T. Rempe, A.Z. Obeidat, G. Ganesh, L. Zhovtis Ryerson, T. Smith, J. Rose, A. Carass, O. Chalayon, M. Kruse-Hoyer, M. Salami, B. Dewey, E. Ogburn, C. Koch, J.L. Prince, S.D. Cassard, S.D. Newsome, and TREAT-MS Trial Team, "The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial: Design and baseline characteristics of participants", Contemporary Clinical Trials, 108117, 2025. DOI: "The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial: Design and baseline characteristics of participants"
  • C. Rivas, J. Zhang, S. Wei, S.W. Remedios, A. Carass, and J.L. Prince, "Automatic unique Identification of multiple sclerosis lesion from MR Images", Proceedings of SPIE Medical Imaging (SPIE-MI 2025), San Diego, CA, February 16–20, 2025. DOI: "Automatic unique Identification of multiple sclerosis lesion from MR Images" arXiv: "Automatic unique Identification of multiple sclerosis lesion from MR Images"
  • J. Zhang, L. Zuo, Y. Liu, S. Remedios, B. A. Landman, J.L. Prince, and A. Carass, "Bi-directional MS lesion filling and synthesis using denoising diffusion implicit model-based lesion repainting", Proceedings of SPIE Medical Imaging (SPIE-MI 2025), San Diego, CA, February 16–20, 2025. DOI: "Bi-directional MS lesion filling and synthesis using denoising diffusion implicit model-based lesion repainting" arXiv: "Bi-directional MS lesion filling and synthesis using denoising diffusion implicit model-based lesion repainting"
  • M. Bilgel, L. Zuo, S.M. Resnick, and A. Carass, "Counterfactual brain amyloid pathology image synthesis", Proceedings of SPIE Medical Imaging (SPIE-MI 2025), San Diego, CA, February 16–20, 2025. DOI: "Counterfactual brain amyloid pathology image synthesis"
  • S.P. Hays, S.W. Remedios, L. Zuo, E.M. Mowry, S.D. Newsome, P.A. Calabresi, A. Carass, B.E. Dewey, and J.L. Prince, "Beyond MR Image Harmonization: Resolution Matters Too", Simulation and Synthesis in Medical Imaging (SASHIMI 2024) in conjunction with the 27th International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI 2024), Marrakesh, Morocco, October 6–10, 2024. DOI: "Beyond MR Image Harmonization: Resolution Matters Too" arXiv: "Beyond MR Image Harmonization: Resolution Matters Too"
  • S.W. Remedios, B.E. Dewey, A. Carass, S.D. Cassard, C. Koch, A. Fishman, J.L. Prince, E.M. Mowry, S.D. Newsome, and P.A. Calabresi, "Assessing Central Vein Sign Visibility across Various Anisotropic MRI Resolutions for Multiple Sclerosis Diagnosis", 2024 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, Nashville, TN, May 29 - June 1, 2024.
  • J. Zhang, L. Zuo, B.E. Dewey, S.W. Remedios, D.L. Pham, A. Carass, and J.L. Prince, "Towards an accurate and generalizable multiple sclerosis lesion segmentation model using self-ensembled lesion fusion", 21st IEEE International Symposium on Biomedical Imaging (ISBI 2024), Athens, Greece, May 27–30, 2024. DOI: "Towards an accurate and generalizable multiple sclerosis lesion segmentation model using self-ensembled lesion fusion" arXiv: "Towards an accurate and generalizable multiple sclerosis lesion segmentation model using self-ensembled lesion fusion"
  • J. Zhang, L. Zuo, B.E. Dewey, S.W. Remedios, S.P. Hays, D. L. Pham, J.L. Prince, and A. Carass, "Harmonization-enriched domain adaptation with light fine-tuning for multiple sclerosis lesion segmentation", Proceedings of SPIE Medical Imaging (SPIE-MI 2024), San Diego, CA, February 18–22, 2024. DOI: "Harmonization-enriched domain adaptation with light fine-tuning for multiple sclerosis lesion segmentation" arXiv: "Harmonization-enriched domain adaptation with light fine-tuning for multiple sclerosis lesion segmentation"
  • L. Zuo, Y. Liu, Y. Xue, B.E. Dewey, S.W. Remedios, S.P. Hays, M. Bilgel, E.M. Mowry, S.D. Newsome, P.A. Calabresi, S.M. Resnick, J.L. Prince, and A. Carass, "HACA3: A unified approach for multi-site MR image harmonization", Computerized Medical Imaging and Graphics, 109:102285, 2023. DOI: "HACA3: A unified approach for multi-site MR image harmonization" arXiv: "HACA3: A unified approach for multi-site MR image harmonization"   HACA3 Code
  • L. Zuo, S.P. Hays, B.E. Dewey, S.W. Remedios, Y. Xue, S.D. Cassard, C. Koch, A. Fishman, A. Carass, J.L. Prince, E.M. Mowry, and S.D. Newsome, "Inconsistent MR acquisition in longitudinal volumetric analysis: Impacts and solutions", 2023 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, Aurora, CO, May 31 - June 3, 2023. Inconsistent MR acquisition in longitudinal volumetric analysis: Impacts and solutions
  • S.P. Hays, L. Zuo, B.E. Dewey, S.W. Remedios, Y. Xue, S.D. Cassard, C. Koch, A. Fishman, A. Carass, P.A. Calabresi, J.L. Prince, E.M. Mowry, and S.D. Newsome, "Quantifying contrast differences among MR images used in clinical studies", 2023 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, Aurora, CO, May 31 - June 3, 2023.
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