Brain shunt surgery put to the test in Placebo-Controlled trial
NCT ID NCT05081128
First seen Jun 24, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This study tests whether a brain shunt—a device that drains extra fluid—can improve walking and thinking in older adults with idiopathic normal pressure hydrocephalus (iNPH). One hundred participants will either receive an active shunt or a placebo procedure. The main goal is to see if the active shunt improves gait speed after three months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- programmable CSF shunt valve (brain shunt surgery)
- What this could lead to
- If successful, this trial could confirm that shunt surgery effectively improves walking and thinking in people with normal pressure hydrocephalus.
- What could go wrong
- This is a relatively small, early-stage trial with 100 participants, and results may not apply to all patients. Shunt surgery carries risks like infection or over-drainage of fluid.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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99 people
The number who actually took part.
- Started
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May 2022
- Finished
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Feb 2026
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Age ≥ 60 years; and 2. Diagnosis of iNPH and recommendation for shunt surgery based on the Investigator's clinical judgement based on criteria and testing as described in the iNPH Guidelines; 3. Evans Ratio ≥ 0.30; and 4. One positive supplementary test to include either large volume Lumbar Puncture or extended CSF drainage per institutional standards; and 5. History or evidence of gait impairment (such as decreased step height or length, decreased speed, retropulsion as described in the iNPH Guidelines) duration ≥ 6 months; and 6. Participant has the sensory motor skills, communication skills and understanding to comply with the testing and reporting required in the PENS trial; and 7. Participant is able to give written informed consent. Exclusion Criteria: 1. Unable to walk 10 meters with or without an assistive device; or 2. Baseline fastest gait velocity (out of three gait trials) \>1 m/sec prior to drainage trial and fastest gait velocity improvement is \< 30% with or without an assistive device; or 3. Unable to return to the study center for follow up evaluation and shunt programming; or 4. Participant is not medically cleared for shunt surgery per local standards; or 5. Secondary NPH. (Prior encephalitis, meningitis, subarachnoid hemorrhage, traumatic brain injury (including concussion) within two years or with brain injury or skull fracture on baseline imaging, brain abscess, brain tumor, obstructive hydrocephalus (including acquired aqueductal stenosis and carcinomatous meningitis); or 6. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus; or 7. Previous intracranial neurosurgical procedure; or 8. Symptomatic cerebral or cerebellar infarction occurring within 6 months from screening (asymptomatic lacunar infarctions are permitted); or 9. Diagnosis of Parkinsonian syndrome that, in the investigator's judgment, will complicate the outcome evaluation; or 10. Diagnosis of schizophrenia or any psychiatric diagnosis (including depression) that, in the investigator's judgment, will complicate the outcome evaluation (such as neuroleptic treatment for schizophrenia); or 11. Diagnosis of dementia disorder where the investigator considers cognition deficit limits participation in the study; or 12. Conditions impairing gait that are considered to be unrelated to hydrocephalus, such as hemiparesis, spasticity, cerebellar ataxia or musculoskeletal and joint disease, which will interfere with gait assessment or the potential for gait improvement. 13. Individuals with contraindication to MRI (e.g., implanted electric and electronic devices, aneurysm clip(s), any metallic fragment or foreign body, coronary and peripheral artery stents, cardiac pacemaker, known claustrophobia, or known/possible pregnancy or breast-feeding) will be excluded according to institutional guidelines.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Emory University
Atlanta, Georgia, 30322, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Johns Hopkins University
Baltimore, Maryland, 21287, United States
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Mayo Clinic
Rochester, Minnesota, 55905, United States
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Mount Sinai Health System
New York, New York, 10029, United States
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New York University Langone Health
New York, New York, 10016, United States
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Oregon Health & Science University
Portland, Oregon, 97239, United States
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Pacific Neuroscience Institute
Santa Monica, California, 90404, United States
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The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-8855, United States
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Umeå University
Umeå, 901 87, Sweden
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University of British Columbia
Vancouver, Canada
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University of Calgary
Calgary, Alberta, AB T2N 1N4, Canada
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University of California, Davis
Davis, California, 95616, United States
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University of South Florida
Tampa, Florida, 33612, United States
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University of Southern California
Los Angeles, California, 90089, United States
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University of Washington
Seattle, Washington, 98195, United States
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157-1029, United States
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Other studies related to the condition(s) this trial covers.
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- Unsteady gait in seniors may be a treatable brain disorder, new study suggests