Clinical Outcomes Following Shunting for Idiopathic Normal Pressure Hydrocephalus (iNPH)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 18-006612
    Sponsor Protocol Number: 18-006612

About this study

The purpose of this study is to collect data to objectively monitor the clinical outcomes of patients following CSF shunting for the treatment of idiopathic normal pressure hydrocephalus in order to optimize the surgical care of patients with this disease.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Diagnosis of iNPH based on clinical criteria and testing as described in the international iNPH guidelines.
  • One positive supplementary test whether infusion test, large volume LP or extended CSF drainage.
  • Duration of gait impairment at least 6 months.
  • Arrested congenital hydrocephalus from aqueductal stenosis without prior treatment.

Exclusion Criteria: 

  • Unable to return to Mayo Clinic for follow-up evaluation.
  • Patient is not medically cleared for shunt surgery per local standards.
  • Patients with contraindications will not undergo MRI or MR elastography imaging.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Benjamin Elder, M.D., Ph.D.

Open for enrollment

Contact information:

Neurosurgery Research Team

(507) 293-7354

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20439171

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