Hydrocephalus, Normal PressurePULSE-OPTNCT03076723
Using Cerebrospinal Fluid Dynamics to Optimize Treatment of Idiopathic Normal Pressure Hydrocephalus
A study testing Change in shunt opening pressure and Simulated change in shunt opening pressure in people with Hydrocephalus, Normal Pressure, run by Umeå University at 5 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hydrocephalus, Normal Pressure
- What is being tested?
- Change in shunt opening pressure and Simulated change in shunt opening pressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 Jun 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Improvement after cerebrospinal fluid (CSF) tap (i.e. positive tap test), or;
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- Increased CSF outflow resistance, or;
- A combination of "typical" signs/symptoms + "typical" MRI findings;
- A combination of a-c.
Who cannot join
- NPH due to hemorrhage, meningitis or stroke (secondary NPH).
- Symptom duration ≥ 5 years.
- Patients considered surgical risk.
- Baseline gait velocity >1.1 m/sec (60 m/min) without assistant device
- Mini Mental State Exam score ≤ 20 points.
- Musculoskeletal condition precluding gait assessment.
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- Severe hearing or visual impairment
- Medication in the form of warfarin or novel oral anticoagulant (NOAC)
- Insufficient pressure data below resting pressure during the CSF infusion investigation, i.e. no complete assessment of the pulsatility curve
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden3 sites
Sahlgrenska university hospital
Gothenburg, 41345
Umeå university hospital
Umeå, 90185
The Uppsala university hospital
Uppsala, 75185
Finland2 sites
Kuopio university hospital
Kuopio, 70210
Turku university hospital
Turku, 20521
About this study
Official title: Using Cerebrospinal Fluid Dynamics to Identify Shunt Responders in Idiopathic Normal Pressure Hydrocephalus and to Optimize Postoperative Clinical Improvement While Minimizing Overdrainage Related Complications - A Double Blind Randomized Study
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:
- The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in INPH patients. With a "fixed" shunt opening pressure, the preoperatively assessed potential pulse amplitude reduction (determined by analysis of the pulsatility curve) predicts postoperative improvement in gait velocity and cognitive functions.
- A postoperative pulsatility curve can be used to further optimize ICP pulsatility by guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve three months postoperatively will increase improvement, but not complications, compared to a shunt with "fixed" opening pressure.
Read more
Based on these hypotheses, three specific aims for the study have been defined:
- To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude.
- To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery.
- To compare outcome six months after surgery and complications rates between INPH patients with a "fixed" opening pressure versus those where the shunt has been adjusted based on the pulsatility curve, three months after the shunt insertion.
- Conditions
- Hydrocephalus, Normal Pressure
- Being tested
- Change in shunt opening pressure, Simulated change in shunt opening pressure
- Medical subject headings
- Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in shunt opening pressureOther
An individually determined change in shunt opening pressure is compared to no change in opening pressure.
Simulated change in shunt opening pressureOther
The shunt opening pressure is reset to the same setting.
| Study group | Role | What they receive |
|---|---|---|
| Fixed opening pressure | Sham comparator | The shunt opening pressure is changed to the same setting as at surgery. Receives: Other: Simulated change in shunt opening pressure |
| 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). Receives: Other: Change in shunt opening pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score on European INPH scale
scale describing the cardinal symptoms of INPH
Measured: 3 and 6 months after surgery
Gait velocity
Maximal gait velocity (3 x 10 m)
Measured: 3 and 6 months after surgery
European INPH scale
Change in total score on scale describing the cardinal symptoms of INPH
Measured: baseline (before surgery) and 3 months after surgery
Gait velocity
Maximal gait velocity (3 x 10 m)
Measured: baseline (before surgery) and 3 months after surgery
Secondary outcomes (9)
Computerized General Neuropsychological INPH Test (CoGNIT)
A computerized neuropsychological test battery for use in INPH, which produces a total "neuropsychological" score
Measured: baseline (before surgery) and 3 months after surgery
Timed up and go test
Mobility test: rise from chair, walk 3 m, turn around, walk back and sit down again
Measured: 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
Measured: baseline (before surgery) and 3 months after surgery
Urogenital Distress Inventory (UDI-6)
Continence assessment scale
Measured: baseline (before surgery) and 3 months after surgery
Incontinence Impact Questionnaire, Short Form (IIQ-7)
Continence assessment scale
Measured: baseline (before surgery) and 3 months after surgery
Barthel Index
Activities of daily living assessment scale
Measured: baseline (before surgery) and 3 months after surgery
Modified Rankin scale
Disability assessment scale
Measured: 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
Measured: baseline (before surgery) and 3 months after surgery
Mini-mental state examination (MMSE) score
Score on the MMSE scale (general mental status)
Measured: baseline (before surgery) and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study start13 Jun 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Acceptable duration exceeded. Enrolment too slow due to covid pandemic and extensive protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydrocephalus, Normal PressureStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Uppsala University Hospital, Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Jan Malm, MD, PhD, Principal investigator, University Hospital, UmeåSara Qvarlander, PhD, Study director, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076723
- Sponsor's protocol ID
- UMU-2016-CSFD-PC
- Acronym
- PULSE-OPT
- Status last verified
- May 2022
- First submitted
- 13 Dec 2016
- Last updated
- 23 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Cerebrospinal Fluid Dynamics to Identify Shunt Responders in Idiopathic Normal Pressure Hydrocephalus and to Optimize Postoperative Clinical Improvement While Minimizing Overdrainage Related Complications - A Double Blind Randomized Study
- ClinicalTrials.gov ID
- NCT03076723
- Acronym / sponsor ID
- PULSE-OPT / UMU-2016-CSFD-PC
- Conditions
- Hydrocephalus, Normal Pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Acceptable duration exceeded. Enrolment too slow due to covid pandemic and extensive protocol.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, Uppsala University Hospital, Kuopio University Hospital
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The pulsatility curve may be the best auxiliary test to predict shunt surgery outcome in INPH patients. With a "fixed" shunt opening pressure, the preoperatively assessed potential pulse amplitude reduction (determined by analysis of the pulsatility curve) predicts postoperative improvement in gait velocity and cognitive functions.
- A postoperative pulsatility curve can be used to further optimize ICP pulsatility by guiding opening pressure adjustment. Shunt adjustment based on the pulsatility curve three months postoperatively will increase improvement, but not complications, compared to a shunt with "fixed" opening pressure.
Based on these hypotheses, three specific aims for the study have been defined:
- To determine if improvement three month after surgery is associated with postoperative reduction in pulse amplitude.
- To determine if a pulsatility curve obtained preoperatively can predict improvement in gait velocity and cognitive functions in INPH patients three months after surgery.
- To compare outcome six months after surgery and complications rates between INPH patients with a "fixed" opening pressure versus those where the shunt has been adjusted based on the pulsatility curve, three months after the shunt insertion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed opening pressure | Sham comparator | Other: Simulated change in shunt opening pressureThe shunt opening pressure is changed to the same setting as at surgery. |
| Individual shunt opening pressure | Experimental | Other: Change in shunt opening pressureThe 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (9 listed)
- NPH due to hemorrhage, meningitis or stroke (secondary NPH).
- Symptom duration ≥ 5 years.
- Patients considered surgical risk.
- Baseline gait velocity >1.1 m/sec (60 m/min) without assistant device
- Mini Mental State Exam score ≤ 20 points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in shunt opening pressureAn individually determined change in shunt opening pressure is compared to no change in opening pressure. | Other | Individual shunt opening pressure |
| Simulated change in shunt opening pressureThe shunt opening pressure is reset to the same setting. | Other | Fixed opening pressure |
Primary outcome
Change in total score on European INPH scale
Time frame: 3 and 6 months after surgery
scale describing the cardinal symptoms of INPH
Gait velocity
Time frame: 3 and 6 months after surgery
Maximal gait velocity (3 x 10 m)
European INPH scale
Time frame: baseline (before surgery) and 3 months after surgery
Change in total score on scale describing the cardinal symptoms of INPH
Gait velocity
Time frame: baseline (before surgery) and 3 months after surgery
Maximal gait velocity (3 x 10 m)
9 secondary outcomes
Computerized General Neuropsychological INPH Test (CoGNIT)
Time frame: baseline (before surgery) and 3 months after surgery
Timed up and go test
Time frame: baseline (before surgery) and 3 months after surgery
EuroQoL's (EQ) standardized 5 dimensions (5D) 5 levels (5L) instrument (EQ-5D-5L™)
Time frame: baseline (before surgery) and 3 months after surgery
Urogenital Distress Inventory (UDI-6)
Time frame: baseline (before surgery) and 3 months after surgery
Incontinence Impact Questionnaire, Short Form (IIQ-7)
Time frame: baseline (before surgery) and 3 months after surgery
Barthel Index
Time frame: baseline (before surgery) and 3 months after surgery
Modified Rankin scale
Time frame: baseline (before surgery) and 3 months after surgery
Geriatric depression scale (GDS-15)
Time frame: baseline (before surgery) and 3 months after surgery
Mini-mental state examination (MMSE) score
Time frame: baseline (before surgery) and 3 months after surgery
Results and safety
The study was stopped early (reason given: Acceptable duration exceeded. Enrolment too slow due to covid pandemic and extensive protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Malm, MD, PhD principal investigator
University Hospital, Umeå
Sara Qvarlander, PhD study director
Umeå University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change in shunt opening pressure and Simulated change in shunt opening pressure in people with Hydrocephalus, Normal Pressure, run by Umeå University at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Acceptable duration exceeded. Enrolment too slow due to covid pandemic and extensive protocol.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in total score on European INPH scale (time frame: 3 and 6 months after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.