Non-invasive Diagnostics of Shunt Obstruction in Adult Hydrocephalus

NCT07172841 | Not Yet Recruiting FDA Device

• 2 other identifiers: Dnr 2024-01568-01Dnr: SU2024-06898
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. Thirdly to investigate correlations with clinical symptom burden before and after surgery. The main questions it aims to answer are: 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.

Conditions

Normal Pressure Hydrocephalus Patients; Normal Pressure Hydrocephalus

Keywords

Volumetry; Shunt obstruction; Shunt patency; NPH; Outcome

Outcome Measures

Primary Outcomes (1)

• Volumetry of CSF

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

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

Secondary Outcomes (1)

• Symptom burden

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

Other Outcomes (1)

• Blood biomarker concentrations

  Preoperatively (doctors appointment with diagnostics) --> 1 day preop --> 1 day postop --> 3 months postop --> 3 months + 7 days postop

Interventions

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to conform to instructions of the study

Sponsors & Collaborators

• Göteborg University: lead
• Department of Neurological Surgery, Sahlgrenska University Hospital: collaborator
• Hydrocephalus Research Unit, Sahlgrenska University Hospital: collaborator
• Department of Neurological Surgery, Linköping University Hospital: collaborator
• Department of Neurology, Linköping University Hospital: collaborator

Related Publications (8)

• 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.

  PMID: 35843939 BACKGROUND

• 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.

  PMID: 34119253 BACKGROUND

• 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.

  PMID: 35377407 BACKGROUND

• 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.

  PMID: 25192478 BACKGROUND

• 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.

  PMID: 26315004 BACKGROUND

• 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.

  PMID: 28498794 BACKGROUND

• 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.

  PMID: 32527841 BACKGROUND

• 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.

  PMID: 5889177 BACKGROUND

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blinded randomized controlled study

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: September 15, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 31, 2034
• Last Updated: September 15, 2025

Record last verified: 2025-09