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

  • 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"
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