Idiopathic Normal Pressure Hydrocephalus: Focus on Imaging and Clinical Symptoms.

NCT04808076 | Completed DMC

• 1 other identifier: LinkoepingU2
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

LiNPH is a prospective single center clinical and radiological study.

Conditions

Fecal Incontinence with Fecal Urgency; Urine Incontinence; Diffusion Tensor Imaging; Leukoencephalopathies

Keywords

Tract-Based Spatial Statistics; DTI; fecal incontinence; urine incontinence; whiter matter changes

Outcome Measures

Primary Outcomes (1)

• White Matter Changes in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study.

  Franctional Anisotropi and Apparent Diffusion Coefficient changes before and 3 months after the shunt surgery and correlation with clinical data. All data will be compared with results from the Healthy individual group.

  2 years

Secondary Outcomes (1)

• Gastrointestinal and urinary symptoms in idiopathic Normal Pressure Hydrocephalus.

  2 years

Other Outcomes (1)

• Tract-based spatial statistics and diffusion tensor imaging in patients with idiopathic Normal Pressure Hydrocephalus.

  2 years

Study Arms (2)

iNPH patients

ACTIVE COMPARATOR

Shunt operation

Procedure: Shunt surgery

Healthy Individuals

NO INTERVENTION

Healthy individuals without any neurological disease.

Interventions

Shunt surgery PROCEDURE

Shunt operation

iNPH patients

Eligibility Criteria

• Age: 61 Years - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

University Hospital of Linköping

Linköping, Sweden

Location

Related Publications (7)

• Eleftheriou A, Blystad I, Tisell A, Gasslander J, Lundin F. Publisher Correction: Indication of Thalamo-Cortical Circuit Dysfunction in Idiopathic Normal Pressure Hydrocephalus: A Diffusion Tensor Imaging Study. Sci Rep. 2020 Jul 16;10(1):12014. doi: 10.1038/s41598-020-69149-x.

  PMID: 32678296 BACKGROUND

• Keong NC, Pena A, Price SJ, Czosnyka M, Czosnyka Z, DeVito EE, Housden CR, Sahakian BJ, Pickard JD. Diffusion tensor imaging profiles reveal specific neural tract distortion in normal pressure hydrocephalus. PLoS One. 2017 Aug 17;12(8):e0181624. doi: 10.1371/journal.pone.0181624. eCollection 2017.

  PMID: 28817574 BACKGROUND

• Siasios I, Kapsalaki EZ, Fountas KN, Fotiadou A, Dorsch A, Vakharia K, Pollina J, Dimopoulos V. The role of diffusion tensor imaging and fractional anisotropy in the evaluation of patients with idiopathic normal pressure hydrocephalus: a literature review. Neurosurg Focus. 2016 Sep;41(3):E12. doi: 10.3171/2016.6.FOCUS16192.

  PMID: 27581308 BACKGROUND

• Nakanishi A, Fukunaga I, Hori M, Masutani Y, Takaaki H, Miyajima M, Aoki S. Microstructural changes of the corticospinal tract in idiopathic normal pressure hydrocephalus: a comparison of diffusion tensor and diffusional kurtosis imaging. Neuroradiology. 2013 Aug;55(8):971-976. doi: 10.1007/s00234-013-1201-6. Epub 2013 Jun 2.

  PMID: 23728069 BACKGROUND

• Ege S. [Management of urinary incontinence in a geriatric rehabilitation department : Global urinary incontinence assessment incorporating the International Consultation on Incontinence Questionnare - Urinary Incontinence Short Form (ICIQ-UI SF)]. Z Gerontol Geriatr. 2018 Apr;51(3):301-313. doi: 10.1007/s00391-016-1173-3. Epub 2017 Feb 8. German.

  PMID: 28180932 BACKGROUND

• Marmarou A, Black P, Bergsneider M, Klinge P, Relkin N; International NPH Consultant Group. Guidelines for management of idiopathic normal pressure hydrocephalus: progress to date. Acta Neurochir Suppl. 2005;95:237-40. doi: 10.1007/3-211-32318-x_48.

  PMID: 16463856 BACKGROUND

• Ishikawa M, Hashimoto M, Kuwana N, Mori E, Miyake H, Wachi A, Takeuchi T, Kazui H, Koyama H. Guidelines for management of idiopathic normal pressure hydrocephalus. Neurol Med Chir (Tokyo). 2008;48 Suppl:S1-23. doi: 10.2176/nmc.48.s1.

  PMID: 18408356 BACKGROUND

MeSH Terms

Conditions

Nocturnal Enuresis; Leukoencephalopathies; Fecal Incontinence

Condition Hierarchy (Ancestors)

Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Fredrik Lundin, MD, PhD

  Department of Neurology and Department of Biomedical and Clinical Sciences, Linköping University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Officer, MD, PhD

Model Details: INPH patients and Healthy Individuals.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: March 19, 2021
• Study Start: September 12, 2020
• Primary Completion: January 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 6, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)