What is the mechanism of action of this treatment?

Cerebrospinal fluid (CSF) shunt surgery is a common treatment for Normal Pressure Hydrocephalus (NPH). The procedure involves implanting a shunt system that drains excess CSF from the brain's ventricles to another part of the body, such as the abdominal cavity, where it can be absorbed. This helps to relieve the symptoms of NPH, which include gait disturbances, urinary incontinence, and cognitive impairment. By reducing the pressure and volume of CSF in the brain, shunt surgery can significantly improve the quality of life for NPH patients, addressing both physical and cognitive symptoms.

What side effects are associated with this type of intervention?

The most common treatment for Normal Pressure Hydrocephalus (NPH) is cerebrospinal fluid (CSF) shunt surgery, which involves draining excess cerebrospinal fluid to relieve symptoms. Known side effects of CSF shunt surgery include infection, shunt malfunction or blockage, subdural hematoma, over-drainage or under-drainage of CSF, and seizures. These complications can lead to symptoms such as headaches, nausea, vomiting, and changes in mental status. Regular follow-up is essential to monitor for these potential side effects and ensure the shunt is functioning properly.

What prior FDA approvals exist?

The provided context does not mention specific FDA approvals for the treatment of Normal Pressure Hydrocephalus (NPH). However, the primary treatment for NPH, which is being studied in the PENS trial, involves cerebrospinal fluid (CSF) shunt surgery. This procedure drains excess cerebrospinal fluid to relieve symptoms of idiopathic Normal Pressure Hydrocephalus (iNPH). CSF shunt surgery remains the mainstay treatment for managing iNPH symptoms.

What other types of research exist?

As of 2024, promising novel alternatives to CSF shunt surgery for Normal Pressure Hydrocephalus (NPH) patients include: 1) Endoscopic third ventriculostomy (ETV), which creates a bypass for cerebrospinal fluid (CSF) flow within the brain, potentially reducing the need for shunts. 2) Pharmacological treatments targeting CSF production and absorption, though still in experimental stages, may offer non-surgical options. 3) Advanced neuromodulation techniques, such as deep brain stimulation (DBS), are being explored for their potential to alleviate symptoms by modulating neural pathways involved in CSF dynamics.

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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

Must not have

Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus

Unable to walk 10 meters with or without an assistive device

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Summary

This trial is testing a special device that manages brain fluid flow in patients with a condition called idiopathic Normal Pressure Hydrocephalus. The device can be adjusted to manage symptoms by either allowing or blocking fluid drainage.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery or procedures for water on the brain.

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I cannot walk 10 meters even with help.

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I cannot return to the study center for follow-up visits or adjustments.

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I can walk faster than 1 meter per second and my walking speed hasn't improved by 30% even with help.

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I am not approved for shunt surgery according to local health standards.

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I have had brain surgery before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Bladder Control as assessed by the Overactive Bladder Questionnaire, short form

Change in Gait velocity

Cognition as assessed by the Montreal Cognitive Assessment (MoCA)

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Cerebrospinal fluid (CSF) shunt surgery is a common treatment for Normal Pressure Hydrocephalus (NPH). The procedure involves implanting a shunt system that drains excess CSF from the brain's ventricles to another part of the body, such as the abdominal cavity, where it can be absorbed. This helps to relieve the symptoms of NPH, which include gait disturbances, urinary incontinence, and cognitive impairment. By reducing the pressure and volume of CSF in the brain, shunt surgery can significantly improve the quality of life for NPH patients, addressing both physical and cognitive symptoms.