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CSF Shunt Valve

CSF Shunt Surgery for Normal Pressure Hydrocephalus (PENS Trial)

N/A
Recruiting
Led By Mark Luciano, MD, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
One positive supplementary test to include either large volume Lumbar Puncture or extended CSF drainage per institutional standards
Age ≥ 60 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

PENS Trial Summary

This trial is testing whether a CSF shunt surgery is effective in iNPH patients. The trial is blinded, meaning the patients do not know if they are receiving the surgery or a placebo, and it is randomized, meaning the patients are randomly assigned to either group.

Who is the study for?
This trial is for people aged 60 or older with idiopathic Normal Pressure Hydrocephalus (iNPH) who have been recommended for shunt surgery. They must be able to walk at least 10 meters, give consent, and follow the study's procedures. Exclusions include recent strokes, Parkinsonian syndrome, severe dementia, prior brain surgeries for hydrocephalus, unrelated gait impairing conditions, certain psychiatric diagnoses affecting outcome evaluation, and contraindications to MRI.Check my eligibility
What is being tested?
The PENS trial is testing the effectiveness of a programmable cerebrospinal fluid (CSF) shunt valve in patients with iNPH. Participants are randomly assigned to receive either the actual shunt surgery or a placebo procedure in this blinded study across multiple centers.See study design
What are the potential side effects?
While specific side effects are not listed here, CSF shunt surgery can typically involve risks such as infection at the surgical site, headaches due to changes in CSF pressure levels post-surgery and potential blockage or malfunction of the shunt.

PENS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a positive result from a major spinal fluid test.
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I am 60 years old or older.

PENS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Bladder Control as assessed by the Overactive Bladder Questionnaire, short form
Change in Gait velocity
Cognition as assessed by the Montreal Cognitive Assessment (MoCA)

PENS Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Open Shunt GroupActive Control1 Intervention
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
Group II: Closed Shunt GroupPlacebo Group1 Intervention
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) three months after the procedure.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,245 Previous Clinical Trials
14,816,406 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,337 Previous Clinical Trials
648,744 Total Patients Enrolled
Mark Luciano, MD, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Programmable CSF Shunt Valve (CSF Shunt Valve) Clinical Trial Eligibility Overview. Trial Name: NCT05081128 — N/A
Normal Pressure Hydrocephalus Research Study Groups: Open Shunt Group, Closed Shunt Group
Normal Pressure Hydrocephalus Clinical Trial 2023: Programmable CSF Shunt Valve Highlights & Side Effects. Trial Name: NCT05081128 — N/A
Programmable CSF Shunt Valve (CSF Shunt Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05081128 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous US-based medical centers running this clinical research?

"University of Calgary, University of South Florida, and Cleveland Clinic are three areas that have been enlisted to help recruit patients for this medical study. Additionally, there are 17 additional sites being used in the recruitment process."

Answered by AI

What is the participant recruitment rate for this experiment?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is presently recruiting patients and has done so since May 18th 2022. The study, which was last revised on November 4th 2022, seeks 100 participants across 17 different sites."

Answered by AI

Is recruitment ongoing for this clinical trial?

"Clinicialtrials.gov indicates that this study is actively seeking participants, with the trial having first been made available to the public on May 18th 2022 and most recently updated on November 4th 2022."

Answered by AI
~53 spots leftby May 2026