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Normal Pressure Hydrocephalus PatientsNCT07172841

Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

A study testing Intervention group "Virtual OFF" in people with Normal Pressure Hydrocephalus Patients and Normal Pressure Hydrocephalus, run by Göteborg University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this RCT is to test whether volumetric assessment of magnetic resonance imaging (MRI) could diagnose shunt obstruction in Adult Hydrocephalus patients, and in addition to explore correlations of blood biomarkers surrounding shunt obstruction. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Intervention group "Virtual OFF"
Type of treatment
Medical device
How many people
60 participants
Where
No sites listed yet
Study dates
15 Sep 2025to 31 Dec 2034
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients with normal pressure hydrocephalus (NPH)
  • Treated at either the Hydrocephalus Research Unit in Gothenburg or at the Department of Neurological Surgery at Linköping University Hospital or Sahlgrenska University Hospital

Who cannot join

  • Unable to conform to instructions of the study

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Dan Farahmand, MD, PhD contact

‭+46 31-342 96 28

dan.farahmand@gu.se

Rebecca Grønning, MD contact

+46 722 224 776

rebecca.gronning@neuro.gu.se

About this study

Official title: Randomized Controlled Study on Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

The goal of this RCT is to test whether volumetric assessment of magnetic resonance imaging (MRI) could diagnose shunt obstruction in Adult Hydrocephalus patients, and in addition to explore correlations of blood biomarkers surrounding shunt obstruction. Thirdly to investigate correlations with clinical symptom burden before and after surgery.

The main questions it aims to answer are:

Read more

Can volumetric assessment of cerebrospinal fluid (CSF) aid in diagnosis of shunt obstruction? Are there dynamical changes in blood biomarker concentrations after shunt obstruction? How are clinical symptom burden and dynamics correlated with blood biomarker changes and volumetric changes in CSF?

After three months of shunt treatment, researchers will compare patients with "Virtual OFF" setting, to explore if simulated shunt obstruction affect measures mentioned above.

Participants randomized to the intervention group will undergo the 'Virtual OFF' setting for a period of 5-7 days, starting 3 months after initiation of shunt treatment. Symptom burden will be assessed preoperatively, at follow-up, and following the week of the shunt setting change. MRI scans will be conducted at these same time points. Participants in the control group will also meet with a nurse, but their shunt settings will remain unchanged. The control group will receive the same symptom assessments and MRI scans as the intervention group.

Being tested
Intervention group "Virtual OFF", Control group (no change in shunt setting)
Keywords
Volumetry, Shunt obstruction, Shunt patency, NPH, Outcome
Medical subject headings
Hydrocephalus, Normal Pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intervention group "Virtual OFF"Device

    Patients randomized to shunt setting "Virtual Off" at the three month follow-up visit. After 5-7 days, the setting will be restored to the previous setting.

  • Control group (no change in shunt setting)Device

    Patients randomized to continue their shunt setting unchanged

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Volumetry of CSF

    Dynamics of volumetric assessment in lateral ventricles and subarachnoid space will be analyzed in groups as a primary outcome measure.

    Measured: Preoperatively --> 3 months postop --> 3 months + 5-7 days postop

Secondary outcomes (1)

  1. Symptom burden

    Results from 4 clinical tests and 2 self assessment forms will be collected preoperatively, 3 months postop and 3 months + 5-7 days postop. Dynamical changes in symptoms is considered a secondary outcome measure.

    1. Walk-steps: number of steps on a 10 meter walk
    2. Walk-time: number of seconds to walk 10 meters
    3. Color naming test by Stroop
    4. Grooved peg board test Self assessment of:
    5. Balance
    6. Urinary continence

    Measured: Preoperatively --> 3 months postop --> 3 months + 5-7 days postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion31 Dec 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-blinded randomized controlled study
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172841
Sponsor's protocol ID
Dnr 2024-01568-01
Other IDs
Dnr: SU2024-06898
Status last verified
Sep 2025
First submitted
7 Mar 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Liden S, Farahmand D, Laurell K. Ventricular volume in relation to lumbar CSF levels of amyloid-beta 1-42, tau and phosphorylated tau in iNPH, is there a dilution effect? Fluids Barriers CNS. 2022 Jul 17;19(1):59. doi: 10.1186/s12987-022-00353-9.

    PubMed 35843939

  • Hallen T, Olsson DS, Hammarstrand C, Farahmand D, Olofsson AC, Jakobsson Ung E, Jakobsson S, Bergquist H, Blennow K, Zetterberg H, Johannsson G, Skoglund T. Circulating brain injury biomarkers increase after endoscopic surgery for pituitary tumors. J Clin Neurosci. 2021 Jul;89:113-121. doi: 10.1016/j.jocn.2021.04.030. Epub 2021 May 12.

    PubMed 34119253

  • Newcombe VFJ, Ashton NJ, Posti JP, Glocker B, Manktelow A, Chatfield DA, Winzeck S, Needham E, Correia MM, Williams GB, Simren J, Takala RSK, Katila AJ, Maanpaa HR, Tallus J, Frantzen J, Blennow K, Tenovuo O, Zetterberg H, Menon DK. Post-acute blood biomarkers and disease progression in traumatic brain injury. Brain. 2022 Jun 30;145(6):2064-2076. doi: 10.1093/brain/awac126.

    PubMed 35377407

  • Saehle T, Farahmand D, Eide PK, Tisell M, Wikkelso C. A randomized controlled dual-center trial on shunt complications in idiopathic normal-pressure hydrocephalus treated with gradually reduced or "fixed" pressure valve settings. J Neurosurg. 2014 Nov;121(5):1257-63. doi: 10.3171/2014.7.JNS14283. Epub 2014 Sep 5.

    PubMed 25192478

  • Farahmand D, Saehle T, Eide PK, Tisell M, Hellstrom P, Wikkelso C. A double-blind randomized trial on the clinical effect of different shunt valve settings in idiopathic normal pressure hydrocephalus. J Neurosurg. 2016 Feb;124(2):359-67. doi: 10.3171/2015.1.JNS141301. Epub 2015 Aug 28.

    PubMed 26315004

  • Miskin N, Patel H, Franceschi AM, Ades-Aron B, Le A, Damadian BE, Stanton C, Serulle Y, Golomb J, Gonen O, Rusinek H, George AE; Alzheimer's Disease Neuroimaging Initiative. Diagnosis of Normal-Pressure Hydrocephalus: Use of Traditional Measures in the Era of Volumetric MR Imaging. Radiology. 2017 Oct;285(1):197-205. doi: 10.1148/radiol.2017161216. Epub 2017 May 10.

    PubMed 28498794

  • Neikter J, Agerskov S, Hellstrom P, Tullberg M, Starck G, Ziegelitz D, Farahmand D. Ventricular Volume Is More Strongly Associated with Clinical Improvement Than the Evans Index after Shunting in Idiopathic Normal Pressure Hydrocephalus. AJNR Am J Neuroradiol. 2020 Jul;41(7):1187-1192. doi: 10.3174/ajnr.A6620. Epub 2020 Jun 11.

    PubMed 32527841

  • Hakim S, Adams RD. The special clinical problem of symptomatic hydrocephalus with normal cerebrospinal fluid pressure. Observations on cerebrospinal fluid hydrodynamics. J Neurol Sci. 1965 Jul-Aug;2(4):307-27. doi: 10.1016/0022-510x(65)90016-x. No abstract available.

    PubMed 5889177

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group "Virtual OFF" in people with Normal Pressure Hydrocephalus Patients and Normal Pressure Hydrocephalus, run by Göteborg University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dan Farahmand, MD, PhD (‭+46 31-342 96 28, dan.farahmand@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Volumetry of CSF (time frame: Preoperatively --> 3 months postop --> 3 months + 5-7 days postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07172841, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.

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