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New study tests gentler brain surgery for older patients

NCT ID NCT07447479

Disease control Sponsor: Institute for Clinical Effectiveness, Japan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time

Summary

This study compares two surgical approaches for treating idiopathic normal pressure hydrocephalus (iNPH) in people aged 60 and older. One group will receive standard ventriculoperitoneal shunt surgery under general anesthesia, while the other will receive a lumbar-peritoneal shunt under local anesthesia with sedation. The goal is to see if the less invasive local-anesthesia option is just as effective at improving walking ability three months after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
shunt surgery (ventriculoperitoneal or lumbar-peritoneal)
What this could lead to
If the local-anesthesia approach works as well as general anesthesia, it could offer a safer, less invasive surgical option for older patients with normal pressure hydrocephalus.
What could go wrong
This is a Phase 4 trial that hasn't started recruiting yet. The local-anesthesia procedure may not improve walking as much as the standard surgery, and there are always risks with any brain surgery, such as infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Started

Apr 2026

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Probable iNPH patients * Age 60 years or older at the time of the tap test * Patients capable of performing the Timed Up and Go test * Patients assignable within 2 weeks (14 days) of obtaining RCT consent * Patients capable of undergoing shunt surgery within 1 month (30 days) of assignment * Patients capable of follow-up at the assigned facility or referring facility for 12 months after assignment * Patients for whom informed consent was obtained Exclusion Criteria: * Patients deemed unsuitable for lumbar-abdominal shunt surgery due to advanced degeneration of the lumbar spine and spinal canal, etc. * Patients deemed unsuitable for abdominal shunt surgery due to a history of multiple open abdominal surgeries, a history of severe intra-abdominal infection, etc. * Other patients deemed unsuitable by the attending physician

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Conditions

The condition(s) this trial relates to.

normal pressure hydrocephalus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic normal pressure hydrocephalus (INPH)

Contacts and locations

Locations

  • Nadogaya Hospital

    Kashiwa, Chiba, 277-0084, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.