NCT Number: NCT07103681
Idiopathic Normal Pressure Hydrocephalus (iNPH) is a progressive condition of the elderly that results in severe disability. iNPH can dramatically respond to Cerebral spinal fluid(CSF)-shunting where excess ventricular fluid is diverted from the brain. Not all patients with iNPH respond to CSF-shunting however. The reasons for this are uncertain.
Aim 1: To understand if specific nerve pathways (white matter tracts) that are near ventricles are damaged in patients that respond to shunting as opposed to those that do not.
Aim 2: Can we explain shunt non-responsiveness by screening for dementia like illnesses (neurodegeneration) using a large array of methods.
Aim 3: To understand whether wearable activity and bed sleep monitors are palatable in a NPH population and to understand if these metrics relate to quality of life.
Aim 4: To see whether self-administered digital cognitive assessments can measure improvements pre and post surgery.
Interested in participating?
Request Info60 year and older
All sexes
Observational
London, W6 8RF, United Kingdom
Location status: Recruiting
Alex Hayes, MBBS
SUB_INVESTIGATOR
Chris Carswell, PHD, FRCP
CONTACT
Chris Carswell, PHD, FRCP
PRINCIPAL_INVESTIGATOR
Harvey Burns, BSc, MRes
SUB_INVESTIGATOR
Harvey G Burns
CONTACT
Josephine Schena, BSc, MSc
SUB_INVESTIGATOR
This single-centre observational cohort study will follow 50 patients diagnosed with symptomatic Normal Pressure Hydrocephalus (NPH) (idiopathic or late presenting congenital hydrocephalus and not secondary hydrocephalus) through their clinical journey, from initial assessment to post-CSF shunt surgery or a time when surgery is decided against. Separate groups of 50 asymptomatic individuals with chronic hydrocephalus and non-hydrocephalus individuals will act as controls.
Participants will undergo comprehensive clinical assessments including gait, cognitive and urinary evaluations, quality of life measures, serum and CSF degenerative biomarker analysis, diffusion-weighted Magnetic Resonance Imaging (MRI) and optional brain and skin biopsies. Data collection will focus on capturing changes in clinical presentation and imaging findings before and after shunting. REDCap will be utilised as the primary tool for data storage.
Primary outcome measures assess pre and post-shunting imaging changes in shunt-responders and non-responders. Shunt response will be defined as 10% improvement in gait speed. Secondary outcomes evaluate the relationship between biomarkers and clinical outcomes. Longitudinal data will help identify factors distinguishing responders from non-responders, with descriptive and inferential statistics used.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Group 1 (communicating hydrocephalus):
Inclusion criteria
Exclusion criteria
Group 2 (asymptomatic and non-hydrocepahlus dementia and healthy controls):
Inclusion criteria
(Any of the following):
Exclusion criteria
VP Shunt surgery involves surgical insertion of a catheter (tube) to divert brain fluid from the cerebral ventricles to the abdominal peritoneum. This will be performed in Group 1 patients as clinically indicated.
Other names: VP Shunt
Brain and skin biopsy's may be taken during the VP shunt to assist in histological analysis for neurodegenerative changes.
MRI brain with diffusion imagining will be performed before and after shunt surgery.
Time frame: Perioperative
Change from baseline in diffusion tensor imaging (DTI) metrics of white matter pathways (e.g. FA, AD, RD) before and after shunt surgery. The following tracts will be studied: corpus collosum, internal capsule, corona radiata and anterior thalamic radiation.
Time frame: Perioperative
Composite degenerative index (plasma abeta, GFAP, Ptau217, NfL, CSF synuclein RT QuIC and brain and skin histology) will be generated and compared between CSF shunt-responsive and CSF non-responsive groups.
Time frame: From enrolment, at periprocedural and up to 27 weeks
The serum biomarkers will measure a-beta (pg/ml), G-FAB (pg/ml), NfL (pg/ml) and p-tau217 (pg/ml).
Time frame: From enrolment and through study completion, an average of 1 year
The Withings' Sleep mats are devices designed to track sleep patterns. Participants will be offered under mattress sleep monitors capable of showing time spent in bed and analyse sleep cycles.
Time frame: From enrolment and through study completion, an average of 1 year
The Withings' Activity Monitors are devices designed to track physical activity and heart rate. Participants will be offered wrist activity monitors which capture data on steps taken, calories burned and overall movement throughout the day, providing insights into daily activity levels.
Time frame: From enrolment, at periprocedural and up to 27 weeks
Total scores range from 0 to 16, with higher scores indicating better outcomes of balance performance.
Time frame: From enrolment, at periprocedural and up to 27 weeks
Total scores range from 0 to 12, with higher scores indicating better outcomes of gait performance.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
The assessment measures the frequency and severity of urinary incontinence. The total scores range from 0-21. Higher scores indicate worse bladder symptoms.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
The assessment measures the pattern and control of bowel incontinence. The total scores for bowel pattern ranges from 1-21 and bowel control ranges from 0-28. Higher scores indicate worse bowel symptoms.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
The assessment measures the severity and bother of sexual function. The scores for sexual function range from 1-5 and are assessed on an individual basis. Higher scores indicate worse sexual function.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
The assessment measures the quality of life bladder, bowels and sexual function has on the individual. The scores suggest how much they bother the participant and it ranges from 0-10. Higher bother scores indicate lower quality of life.
Time frame: From enrolment, at periprocedural, and up to 27 weeks.
The total score ranges from 0 to 15, with higher scores indicating worse bladder severity symptoms.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Assesses gait disturbance, cognitive impairment and urinary disturbance. Total scores range from 0 to 12, with higher scores indicating better outcomes.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Assesses the severity of depression. Total score ranges from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Assesses the severity of anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating more severe anxiety.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Overall score adds 15 metrics of quality of life. Total scores range from 75-15 with lower scores indicating better quality of life.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Overall score adds 45 metrics of quality of life using a Likert scale to score from 0-5. Total scores range from 0-225 with lower scores indicating better quality of life.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Frailty rating score in older adults. Total scores range from 1 to 9 with higher indicating greater frailty.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Total score evaluates cognitive functions including memory, language, visuospatial, attention and language. Total scores range from 0 to 100, with higher scores indicating better cognitive function.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Includes a total score of a collection of cognitive tests to assess various cognitive domains in those with NPH pre and post surgery. There are specific domain specific scores.
Time frame: From enrolment, at periprocedural and up to 27 weeks.
Objective gait metric data is taken from the Protokinetics gait mat to analyse gait parameters of those with NPH. These metrics include, all aspects of gait (e.g. foot length, gait velocity, stride length)
Contact information is provided by the study sponsor or research team.
Chris Carswell
CONTACT
Harvey G Burns
CONTACT
Imperial College London
Other
Observational Study to Investigate the Effect of White Matter Tract Distortion and Neurodegenerative Biomarkers on Shunt-responsiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH)
Acronym: OWN-NPH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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