An interventional study of programmable CSF shunt valve in Idiopathic Normal Pressure Hydrocephalus (INPH), sponsored by Johns Hopkins University. Completed at 7 sites in 3 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
The Placebo-Controlled Effectiveness in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt effectiveness in iNPH patients.
The primary intervention will be setting the FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve to active (open shunt group)(setting 4)(110 mm H2O) or placebo (closed shunt group)(setting 8)(>400 mm H2O)in a 1:1 ratio. By the time of the primary objective evaluation at four months, the closed shunt group will have zero months of active treatment, and the open shunt group will have four months of active treatment. At four months, shunts for subjects in the closed shunt group will be adjusted to setting 4. To maintain blinding, all patients will be adjusted/ mock adjusted to the active setting in a similar fashion. Patients from both groups will not be adjusted before four months of active treatment, unless judged medically necessary by the treating team. Following four months of active treatment, all subjects in each group will have shunt adjustments according to clinical standards at each center.
78 studies on the registry are indexed under Hydrocephalus, Normal Pressure; 20 are open to participants now.
This study's enrollment of 18 is below the median of 49 across 40 interventional studies indexed under Hydrocephalus, Normal Pressure.
Browse Hydrocephalus, Normal Pressure studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to active (open shunt group)(setting 4)(110 mm H2O) at time of shunt implantation
Device: programmable CSF shunt valve
FDA-approved Certas Plus with Siphonguard, programmable CSF shunt valve setting to placebo (closed shunt group)(setting 8)(\>400 mm H2O) at time of shunt implantation followed by setting to active (setting 4) (110 mm H2O) four months after the procedure.
Device: programmable CSF shunt valve
Brain shunt surgery using a programmable CSF shunt valve
Also known as: FDA-approved Certas Plus with Siphonguard
Change in Gait Velocity
Evaluation of CSF shunting in Idiopathic Normal Pressure Hydrocephalus (INPH) patients through a group comparison of improvement from baseline at four months between active and placebo-controlled groups, using the primary endpoint of gait velocity in meters per second (m/s).
Time frame: Baseline and 4 months
Change in Cognition as Assessed by the Montreal Cognitive Assessment (MoCA) Score
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MoCA test to assess cognition. Scores on the MoCA range from 0 to 30 where lower scores signify greater cognitive impairment.
Time frame: Baseline and 4 Months
Change in Bladder Control as Assessed by the Overactive Bladder Questionnaire, Short Form
Evaluate the effect of shunting between active and placebo-controlled groups at four months using Overactive Bladder Questionnaire, short form (OAB-q sf.) to assess bladder control. The OAB-q SF is scored from 0 to 100 with lower scores indicating worse QOL due to bladder control.
Time frame: Baseline and 4 months
Change in Function as Assessed by the Lawton Activities of Daily Living/Independence in Activities of Daily Living (ADL/IADL) Test Score
Evaluate the effect of shunting between active and placebo-controlled groups on change from baseline to four months using ADL/IADL test to assess function. Scores on the Lawton ADL/IADL scale range from 0 to 32 where a lower score indicates less independence in physical and instrumental daily living skills.
Time frame: Baseline and 4 months
Change in Function as Assessed by the Modified Rankin Scale (MRS)
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MRS to assess function. Scores on the MRS range from 0 to 6 where higher scores signify increased disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Time frame: Baseline and 4 months
Change in Cognition as Assessed by the Symbol Digit Modalities Test (SDMT)
Evaluate the effect of shunting between active and placebo-controlled groups at four months using SDMT to assess cognition. Scores on the SDMT range from 0 to 110 where lower scores are associated with reduced psychomotor speed.
Time frame: Baseline and 4 months
Change in Gait Velocity From Shunt Activation to 8 Months After Active Shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting, using the primary outcome of gait velocity. For patients assigned to Open shunt, active shunting is from Baseline to Month 8 of the study. For patients assigned to Closed Shunt, active shunting is from Month 4 of the study (immediately prior to opening of initially Closed shunt) to Month 12 (i.e., after 8 months of the patient having an open shunt).
Time frame: Up to 8 months after active shunting
Change in Cognition Using MoCA From Baseline to 8 Months After Active Shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting using MoCA to assess cognition. Scores on the MoCA range from 0 to 30 where lower scores signify greater cognitive impairment.
Time frame: Baseline and 8 months after active shunting
Change in Bladder Control From Baseline to 8 Months After Active Shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting using OAB-q test to assess bladder control. The OAB-q SF is scored from 0 to 100 with lower scores indicating worse QOL due to bladder control.
Time frame: Baseline and 8 months after active shunting
Change in Function Using ADL/IADL From Baseline to 8 Months After Active Shunting
Evaluate the effect of shunting between active and placebo-controlled groups on change from baseline to four months using ADL/IADL test to assess function. Scores on the Lawton ADL/IADL scale range from 0 to 32 where a lower score indicates less independence in physical and instrumental daily living skills.
Time frame: Baseline and 8 months after active shunting
Change in Function Using MRS From Baseline to 8 Months After Active Shunting
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MRS to assess function. Scores on the MRS range from 0 to 6 where higher scores signify increased disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
Time frame: Baseline and 8 months after active shunting
Change in Cognition Using SDMT From Baseline to 8 Months After Active Shunting
Evaluate the clinical improvement of all study participants at eight months of active shunting using SDMT to assess cognition. Scores on the SDMT range from 0 to 110 where lower scores are associated with reduced psychomotor speed.
Time frame: Baseline and 8 months after active shunting
Number of Patients With Falls
Evaluate the effect of shunting between active and placebo-controlled groups at four months by assessing the number of patients with falls.
Time frame: 4 months
Frequency of Adverse Effects
Evaluate the clinical improvement of all study participants at eight months of active shunting by assessing the frequency of falls, surgical and non-surgical complications, related and unrelated.
Time frame: 8 months
Adverse Events
Compare adverse events (AEs) in the active versus placebo-controlled group at four months and at eight months of active shunting.
Time frame: 4 and 8 months of active shunting
| Milestone | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Started | 9 | 9 |
| 4-month follow-up (randomized evaluation) | 8 | 8 |
| 12-month follow-up (entire study) | 8 | 8 |
| Completed | 8 | 8 |
| Not completed | 1 | 1 |
| Withdrew: Death | 1 | 1 |
Evaluation of CSF shunting in Idiopathic Normal Pressure Hydrocephalus (INPH) patients through a group comparison of improvement from baseline at four months between active and placebo-controlled groups, using the primary endpoint of gait velocity in meters per second (m/s).
| meters per second | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Change in Gait Velocity | 0.28 ± 0.284 | 0.04 ± 0.167 |
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MoCA test to assess cognition. Scores on the MoCA range from 0 to 30 where lower scores signify greater cognitive impairment.
| score on a scale | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Change in Cognition as Assessed by the Montreal Cognitive Assessment (MoCA) Score | -0.13 ± 3.643 | 1.63 ± 1.598 |
Evaluate the effect of shunting between active and placebo-controlled groups at four months using Overactive Bladder Questionnaire, short form (OAB-q sf.) to assess bladder control. The OAB-q SF is scored from 0 to 100 with lower scores indicating worse QOL due to bladder control.
| score on a scale | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Change in Bladder Control as Assessed by the Overactive Bladder Questionnaire, Short Form | -23.3 ± 19.89 | 2.1 ± 17.81 |
Evaluate the effect of shunting between active and placebo-controlled groups on change from baseline to four months using ADL/IADL test to assess function. Scores on the Lawton ADL/IADL scale range from 0 to 32 where a lower score indicates less independence in physical and instrumental daily living skills.
| score on a scale | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Change in Function as Assessed by the Lawton Activities of Daily Living/Independence in Activities of Daily Living (ADL/IADL) Test Score | -5.7 ± 6.73 | 1.4 ± 3.89 |
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MRS to assess function. Scores on the MRS range from 0 to 6 where higher scores signify increased disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
| score on a scale | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Change in Function as Assessed by the Modified Rankin Scale (MRS) | -0.88 ± 1.126 | -0.13 ± 0.641 |
Evaluate the effect of shunting between active and placebo-controlled groups at four months using SDMT to assess cognition. Scores on the SDMT range from 0 to 110 where lower scores are associated with reduced psychomotor speed.
| score on a scale | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Change in Cognition as Assessed by the Symbol Digit Modalities Test (SDMT) | -0.3 ± 6.61 | -0.1 ± 4.02 |
Evaluate the clinical improvement of all study participants at eight months of active shunting, using the primary outcome of gait velocity. For patients assigned to Open shunt, active shunting is from Baseline to Month 8 of the study. For patients assigned to Closed Shunt, active shunting is from Month 4 of the study (immediately prior to opening of initially Closed shunt) to Month 12 (i.e., after 8 months of the patient having an open shunt).
| meters per second | All Randomized Patients |
|---|---|
| Change in Gait Velocity From Shunt Activation to 8 Months After Active Shunting | 0.38 ± 0.229 |
Evaluate the clinical improvement of all study participants at eight months of active shunting using MoCA to assess cognition. Scores on the MoCA range from 0 to 30 where lower scores signify greater cognitive impairment.
| score on a scale | All Randomized Patients |
|---|---|
| Change in Cognition Using MoCA From Baseline to 8 Months After Active Shunting | 1.0 ± 2.92 |
Evaluate the clinical improvement of all study participants at eight months of active shunting using OAB-q test to assess bladder control. The OAB-q SF is scored from 0 to 100 with lower scores indicating worse QOL due to bladder control.
| score on a scale | All Randomized Patients |
|---|---|
| Change in Bladder Control From Baseline to 8 Months After Active Shunting | -25.0 ± 29.42 |
Evaluate the effect of shunting between active and placebo-controlled groups on change from baseline to four months using ADL/IADL test to assess function. Scores on the Lawton ADL/IADL scale range from 0 to 32 where a lower score indicates less independence in physical and instrumental daily living skills.
| score on a scale | All Randomized Patients |
|---|---|
| Change in Function Using ADL/IADL From Baseline to 8 Months After Active Shunting | -4.7 ± 5.88 |
Evaluate the effect of shunting between active and placebo-controlled groups at four months using MRS to assess function. Scores on the MRS range from 0 to 6 where higher scores signify increased disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
| score on a scale | All Randomized Patients |
|---|---|
| Change in Function Using MRS From Baseline to 8 Months After Active Shunting | -0.6 ± 0.96 |
Evaluate the clinical improvement of all study participants at eight months of active shunting using SDMT to assess cognition. Scores on the SDMT range from 0 to 110 where lower scores are associated with reduced psychomotor speed.
| score on a scale | All Randomized Patients |
|---|---|
| Change in Cognition Using SDMT From Baseline to 8 Months After Active Shunting | 5.8 ± 7.21 |
Evaluate the effect of shunting between active and placebo-controlled groups at four months by assessing the number of patients with falls.
| Participants | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Number of Patients With Falls | 0 | 2 |
Evaluate the clinical improvement of all study participants at eight months of active shunting by assessing the frequency of falls, surgical and non-surgical complications, related and unrelated.
Results for this outcome have not been posted.
Compare adverse events (AEs) in the active versus placebo-controlled group at four months and at eight months of active shunting.
Results for this outcome have not been posted.
Collected over From time of randomization until 1 year after initial shunting procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Shunt Group | 1/9 (11.1%) | 3/9 (33.3%) | 6/9 (66.7%) |
| Closed Shunt Group | 1/9 (11.1%) | 1/9 (11.1%) | 4/9 (44.4%) |
| Event | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Muscular WeaknessMusculoskeletal and connective tissue disorders | 1/9 | 0/9 |
| Cerebrovascular AccidentNervous system disorders | 0/9 | 1/9 |
| UrosepsisInfections and infestations | 1/9 | 0/9 |
| Subdural EffusionNervous system disorders | 1/9 | 0/9 |
| CoagulopathyBlood and lymphatic system disorders | 1/9 | 0/9 |
| Gallbladder necrosisHepatobiliary disorders | 1/9 | 0/9 |
| Event | Open Shunt Group | Closed Shunt Group |
|---|---|---|
| Transient Decrease in MOCA ScoreInvestigations | 4/9 | 1/9 |
| HeadacheNervous system disorders | 2/9 | 1/9 |
| Abdominal tendernessGastrointestinal disorders | 0/9 | 1/9 |
| Head injuryInjury, poisoning and procedural complications | 0/9 | 1/9 |
| Abdominal painGastrointestinal disorders | 1/9 | 1/9 |
| DizzinessNervous system disorders | 1/9 | 0/9 |
| Balance disorderNervous system disorders | 1/9 | 0/9 |
| Crohn's diseaseGastrointestinal disorders | 0/9 | 1/9 |
| PyrexiaGeneral disorders | 0/9 | 1/9 |
| Age, Continuous(years) | Open Shunt Group | Closed Shunt Group | Total |
|---|---|---|---|
| Median | 74.0 (73.3 to 77.0) | 74.5 (70.1 to 76.5) | 74.2 (72.1 to 76.6) |
| Sex: Female, Male(Participants) | Open Shunt Group | Closed Shunt Group | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 5 | 5 | 10 |
| Race (NIH/OMB)(Participants) | Open Shunt Group | Closed Shunt Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 9 | 9 | 18 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Open Shunt Group | Closed Shunt Group | Total |
|---|---|---|---|
| Canada | 3 | 3 | 6 |
| Sweden | 1 | 1 | 2 |
| United States | 5 | 5 | 10 |
| Evans' Ratio(no unit) | Open Shunt Group | Closed Shunt Group | Total |
|---|---|---|---|
| Median | 0.36 (0.34 to 0.41) | 0.37 (0.35 to 0.42) | 0.37 (0.34 to 0.42) |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After subject enrollment and follow up have been completed, the Data Coordinating Center (DCC) of the study will prepare a final study database for analysis. A releasable database will be produced and completely de-identified in accordance with the definitions provided in the Health insurance Portability and Accountability Act (HIPAA). Namely, all identifiers specified in HIPAA will be re-coded in a manner that will make it impossible to deduce or impute the specific identity of any patient. The database will not contain any institutional identifiers. The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. In accordance with policies determined by the investigators and funding sponsors, the releasable database will be provided to users in electronic form.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: One year after publication of the results of the primary analysis.
Access criteria: individual participant data (IPD) will be made available to researchers submitting a request for data that includes an analytic plan approved by the Institutional Review Board (IRB) at their institution
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Hydrocephalus, Normal Pressure →