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Acceptable duration exceeded. Enrolment too slow due to covid pandemic and extensive protocol.
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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
| Uppsala University Hospital | OTHER |
| Kuopio University Hospital | OTHER |
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The purpose of the study is to determine if the so called pulsatility curve, which describes the relationship between intracranial pressure (ICP) and ICP pulsatility, can be used to predict outcome of treatment, in the form of shunt surgery, in idiopathic normal pressure hydrocephalus (INPH) and to guide the adjustment of shunt opening pressure after the surgery. The main hypotheses of the study are:
Based on these hypotheses, three specific aims for the study have been defined:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed opening pressure | Sham Comparator | The shunt opening pressure is changed to the same setting as at surgery. |
|
| Individual shunt opening pressure | Experimental | The shunt opening pressure is adjusted (up one step, down one step or unchanged) according to an individual analysis of the pulsatility curve (as assessed after shunt surgery). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Change in shunt opening pressure | Other | An individually determined change in shunt opening pressure is compared to no change in opening pressure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in total score on European INPH scale | scale describing the cardinal symptoms of INPH | 3 and 6 months after surgery |
| Gait velocity | Maximal gait velocity (3 x 10 m) | 3 and 6 months after surgery |
| European INPH scale | Change in total score on scale describing the cardinal symptoms of INPH | baseline (before surgery) and 3 months after surgery |
| Gait velocity | Maximal gait velocity (3 x 10 m) | baseline (before surgery) and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Computerized General Neuropsychological INPH Test (CoGNIT) | A computerized neuropsychological test battery for use in INPH, which produces a total "neuropsychological" score | baseline (before surgery) and 3 months after surgery |
| Timed up and go test |
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Inclusion Criteria:
Possible or probable INPH according to the INPH guidelines.
Symptom duration ≥ 3 months
Age ≥50 years
Able to walk 10 meters with or without an assistant device.
Decision to recommend shunt surgery based either on:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Malm, MD, PhD | University Hospital, Umeå | Principal Investigator |
| Sara Qvarlander, PhD | Umeå University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio university hospital | Kuopio | 70210 | Finland | |||
| Turku university hospital |
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| ID | Term |
|---|---|
| D006850 | Hydrocephalus, Normal Pressure |
| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Simulated change in shunt opening pressure | Other | The shunt opening pressure is reset to the same setting. |
|
Mobility test: rise from chair, walk 3 m, turn around, walk back and sit down again
| baseline (before surgery) and 3 months after surgery |
| EuroQoL's (EQ) standardized 5 dimensions (5D) 5 levels (5L) instrument (EQ-5D-5L™) | EuroQoL's standardized instrument for health outcome, which assesses health in 5 dimensions, on 5 levels | baseline (before surgery) and 3 months after surgery |
| Urogenital Distress Inventory (UDI-6) | Continence assessment scale | baseline (before surgery) and 3 months after surgery |
| Incontinence Impact Questionnaire, Short Form (IIQ-7) | Continence assessment scale | baseline (before surgery) and 3 months after surgery |
| Barthel Index | Activities of daily living assessment scale | baseline (before surgery) and 3 months after surgery |
| Modified Rankin scale | Disability assessment scale | baseline (before surgery) and 3 months after surgery |
| Geriatric depression scale (GDS-15) | Score on a geriatric depression scale consisting of 15 yes/no questions | baseline (before surgery) and 3 months after surgery |
| Mini-mental state examination (MMSE) score | Score on the MMSE scale (general mental status) | baseline (before surgery) and 3 months after surgery |
| Turku |
| 20521 |
| Finland |
| Sahlgrenska university hospital | Gothenburg | 41345 | Sweden |
| Umeå university hospital | Umeå | 90185 | Sweden |
| The Uppsala university hospital | Uppsala | 75185 | Sweden |