Normal Pressure HydrocephalusNCT00727142
Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus (INPH)
A study testing Surgical treatment in people with Normal Pressure Hydrocephalus, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus
- What is being tested?
- Surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2008to Jul 2012
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic Normal pressure Hydrocephalus
Who cannot join
- Alzheimer disease
- Vascular dementia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Hospital for Neurology and Neurosurgery
London, WC1N 3BG
About this study
Official title: Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus
This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.
Read the detailed description
By comparing one group with active CSF shunting with another with non .
- Conditions
- Normal Pressure Hydrocephalus
- Being tested
- Surgical treatment
- Keywords
- NPH, Hydrocephalus, Shunt
- Medical subject headings
- Hydrocephalus, Normal Pressure, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatmentProcedure or surgery
Also called Functioning shunt
Insertion of a functioning shunt
| Study group | Role | What they receive |
|---|---|---|
| open shunt | Active comparator | functioning shunt Receives: Procedure: Surgical treatment |
| closed shunt | Active comparator | NON FUNCTIONING SHUNT Receives: Procedure: Surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in walking speed
Measured: 3 months
Secondary outcomes (1)
improved cognition or continence
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2011
- Study completionJul 2012
Why it stopped: observed benefit of treatment larger than expected
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure HydrocephalusStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A Toma, University College London Hospitals
- Investigators
- Laurence Watkins, FRCS, Principal investigator, NHNN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727142
- Sponsor's protocol ID
- 08/0149
- Status last verified
- May 2018
- First submitted
- 29 Jul 2008
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conservative Versus Surgical Management of Idiopathic Normal Pressure Hydrocephalus
- ClinicalTrials.gov ID
- NCT00727142
- Acronym / sponsor ID
- 08/0149
- Conditions
- Normal Pressure Hydrocephalus
- Keywords
- NPH, Hydrocephalus, Shunt
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: observed benefit of treatment larger than expected
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 1 Aug 2008 (estimated)
- 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.
This study aims to provide class 1 evidence supporting or refuting the existence of normal pressure hydrocephalus.
Detailed description
By comparing one group with active CSF shunting with another with non .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open shunt | Active comparator | Procedure: Surgical treatmentfunctioning shunt |
| closed shunt | Active comparator | Procedure: Surgical treatmentNON FUNCTIONING SHUNT |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Idiopathic Normal pressure Hydrocephalus
Key exclusion criteria (2 listed)
- Alzheimer disease
- Vascular dementia
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 |
|---|---|---|
| Surgical treatmentAlso: Functioning shuntInsertion of a functioning shunt | Procedure or surgery | closed shunt, open shunt |
Primary outcome
improvement in walking speed
Time frame: 3 months
1 secondary outcome
improved cognition or continence
Time frame: 3 months
Results and safety
The study was stopped early (reason given: observed benefit of treatment larger than expected). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
Related trials for Normal Pressure Hydrocephalus
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Active, not recruiting
Evaluation of the Safety and Effectiveness of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
Recruiting
Examining the Feasibility of Using Pressure Gradient Regulated Automated Cerebral Spinal Fluid Drainage During External Lumbar Drain Trials
NPH (Normal Pressure Hydrocephalus)
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
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.
Laurence Watkins, FRCS principal investigator
NHNN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment in people with Normal Pressure Hydrocephalus, run by University College London Hospitals at 1 site in United Kingdom.
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 1 inclusion and 2 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 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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: observed benefit of treatment larger than expected). 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?
improvement in walking speed (time frame: 3 months). 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 16 May 2018.