Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours

About this trial

This will be a single-center, prospective, analytical cohort study. All included patients will undergo transcranial ultrasound (TPI) with measurement of cerebral pulsatility parameters prior to subtractive lumbar puncture during hospitalization in the neurosurgery department, followed by a second ultrasound assessment either at one year after surgery for operated patients, or at one year after the initial ultrasound assessment for non-operated patients. This ultrasound evaluation will be integrated into the routine work-up, which is already systematically performed in cases of suspected idiopathic normal pressure hydrocephalus (iNPH).

The neurosurgical team's decision to perform cerebrospinal fluid (CSF) shunting will be made blinded to the ultrasound measurements and based solely on the standard clinical protocol.

The primary objective of the study is to demonstrate that the mean amplitude of cerebral pulsatility (MeanBTP) prior to subtractive lumbar puncture is significantly higher in patients who show clinical improvement 12 months after CSF shunting compared with those who do not, with a type I error risk (alpha) of 0.05."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult

Suspected iNPH (= at least 1/3 of the triad symptoms + ventriculomegaly on brain imaging)

Hospitalised at Tours University Hospital for 'hydrocephalus assessment'

Patient who has provided written and signed consent

Disqualifiers

Patients already fitted with a CSF shunting system (VPS)

Suspicion of obstructive hydrocephalus (aqueduct stenosis, tumour, etc.)

Patients under legal protection (guardianship, curatorship, judicial protection).

Trial population

Adult with suspected iNPH, hospitalized at Tours University Hospital for "hydrocephalus assessment"

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

110 Participants
are grouped into 2 trial groups
Group A: patients improved after CSF shunting surgery
Group B: patients not improved after CSF shunting surgery

Trial outcomes

Primary outcomes

1

Clinical improvement

Clinical improvement at 12 months in patients who undergo CSF shunt surgery (ventriculoperitoneal shunt, VPS). Clinical improvement will be defined as cognitive improvement at 12 months and/or gait improvement at 12 months. * Cognitive improvement: improvement in at least two cognitive tests. Improvement in a single test will be defined as an increase ≥ 1 standard deviation between the baseline pre-lumbar puncture (pre-LP) speech therapy evaluation and the 12-month postoperative assessment. * Gait improvement: improvement in the Get Up and Go test and/or the 10-meter walk test (10MWT) between baseline and the 12-month postoperative assessment.

Time frame
12 months

Secondary outcomes

1

Mattis Dementia Rating Scale score (MDRS)

Detailed speech therapy (neuropsychological) assessment: Mattis Dementia Rating Scale score (/144)

Time frame
12 months
2

Wechsler Adult Intelligence Scale - 4th edition (WAIS-IV)

Detailed speech therapy (neuropsychological) assessment: WAIS-IV - Coding, Digit Span Forward, Digit Span Backward; Verbal fluency - literal and categorical; Trail Making Test A - duration (s) and errors; Rey-Osterrieth Complex Figure - copy duration (s) and copy score (/36); Rey Word List score (/15).

Time frame
12 months
3

Get Up and Go test (s)

Detailed physiotherapy (motor) assessment: Get Up and Go test (s); Tinetti test (/28)

Time frame
12 months
4

10-meter walk test

Detailed physiotherapy (motor) assessment: 10-meter walk test (10MWT) (s).

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: