Chronic Adult Hydrocephalus Clinical Trial
— Multimod'HCAOfficial title:
Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus
| Verified date | January 2023 |
| Source | University Hospital, Tours |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Idiopathic chronic adult hydrocephalus (ICAH) is due to expansion of the fluid-filled cavities in the brain. The clinical symptoms are gait disturbance, mental decline and incontinence. Treatment involves installing a ventriculoperitoneal shunt which is known to be able to induce regression of the symptoms in many cases meaning that ICAH is a classic, curable cause of dementia. Diagnosis relies on comparing symptoms before and after depleting cerebrospinal fluid (CSF) via a lumbar puncture (LP). In practice, the situation is complicated: improvement is often incomplete and there is no consensus on either how to assess the symptoms or how they change after CSF depletion. In consequence, the decision whether not to undertake surgery often depends on the neurosurgeon's clinical impression. Over recent years, the cognitive profile of patients with ICAH has become better characterised and reproducible, objective techniques have been developed to assess motor function and CSF flow in the brain. The investigators project aims to define the value of these new investigative techniques in the positive diagnosis of ICAH, in comparison to current decision-making tools.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | July 21, 2018 |
| Est. primary completion date | July 21, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | Inclusion Criteria: - Adult 65 years or older - Hospitalized patients (at the University Hospital of Tours) requiring the assessment of chronic hydrocephalus in adults, suspected clinically - Patient undergoing Lumbar Puncture subtractive - Informed consent form signed - Affiliated to a medical insurance Exclusion Criteria: - Contraindications to MRI - Inability to walk or to stand before having lumbar puncture - Patient under trusteeship and guardianship, or judicial protection |
| Country | Name | City | State |
|---|---|---|---|
| France | CHRU de Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Tours |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cerebrospinal fluid biomarkers of degeneration from Alzheimer's disease. | Association between the decision-making with regard to permanent CSF shunt and the response to subtractive lumbar puncture | 5 days | |
| Primary | Computerised gait analysis | Association between the decision-making with regard to permanent CSF shunt and the Computerised gait analysis, | 5 days | |
| Primary | Ultrasound measurement of cerebral pulsatility | Association between the decision-making with regard to permanent CSF shunt and the Ultrasound measurement of cerebral pulsatility, | 5 days | |
| Primary | Qualitative and quantitative analysis (average speed and flow) of the hydrodynamic characteristics of the cerebrospinal fluid. | Association between the decision-making with regard to permanent CSF shunt and the MRI flow, | 5 days | |
| Primary | Urinary incontinence | Association between the decision-making with regard to permanent CSF shunt and the Urinary incontinence scale | 5 days |