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| ID | Type | Description | Link |
|---|---|---|---|
| J&J Proposal #38973 | Other Identifier | J&J Proposal #38973 | |
| Award #032906 | Other Identifier | Award #032906 |
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Funding was withdrawn as number of subjects enrolled did not meet expectation
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The research project is designed to determine which combination of tests will enable physicians to predict whether a patient with symptoms of normal pressure hydrocephalus (NPH) will improve with a shunt.
Normal pressure hydrocephalus (NPH) is a potentially reversible progressive neurological condition disproportionately affecting the elderly population. Given current controversies regarding its exact definition, accurate incidence and prevalence figures are elusive. NPH was first described forty years ago as a triad of symptoms consisting of gait difficulties, urinary incontinence, and memory problems in patients with enlarged ventricles in the absence of increased intracranial pressure (ICP). The cause of primary, or idiopathic NPH (INPH) remains elusive, while secondary NPH results from intracranial insults such as head trauma, meningitis, or intracranial hemorrhage. NPH can be successfully treated with cerebrospinal fluid (CSF) shunting. However, the accurate diagnosis and treatment of patients with NPH remains problematic, despite significant advances in brain imaging and ICP physiology.
Objectives - The primary aims of this study are:
Secondary study aims include:
Investigating the pathophysiology of NPH by: 1) correlating cortical vein compliance measured by MRI flow quantification studies with CSF pressure waveform analysis; 2)assessing funduscopic changes before and during ELD; 3) performing and cross correlating CSF chemical analysis on screening positive and negative patients as well as screening-positive patients who are shunt responsive versus unresponsive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparison for patients of lumbar drain and shunt surgery | Experimental | Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery. Device: Programmable Shunt Insertion (Codman Medtronic) Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy Follow-up testing to be administered by trained physician assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, mini-mental status exam, 9-hole grooved pegboard, motor visual perception test (MVPT), modified rankin score (MRS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programmable Shunt Insertion (Codman, Medtronic) | Device | Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. Patient will be brought to operating room suite where general anesthesia is induced. Patient will be placed with a small roll on shoulder, supine, on the operating room table. Patient's head will be turned with the parietal area uppermost in the field. Patient will be prepared and draped in the usual sterile fashion. Site prep includes parietooccipital area, side of neck, chest, and entire abdomen. Ventricular catheter placed and then attached to shunt valve. Catheter is then fitted over grooved blue burr hole guide. Excess catheter pulled down to pull valve into pocket on the skull. Sterile dressings applied. |
| Measure | Description | Time Frame |
|---|---|---|
| Evans Ratio | A brain CT scan is obtained after the first week to ten days and the shunt is adjusted according to the patients signs and symptoms. Prior to any downward adjustment of the shunt valve (which allows more CSF drainage), a brain CT is obtained to look for subdural hematoma or effusion. If any type of subdural collection is found, the valve pressure is increased (to reduce CSF flow) until the collection resolves. | initial and follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Therapy, Occupational Therapy, and Speech Therapy | The evaluations for physical therapy, occupational therapy and speech therapy are performed along with external lumbar drainage (ELD) to assess NPH subjects. | 30 min per clinic visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Pare, MD, FRCSC | UC Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine - Medical Center | Orange | California | 92868 | United States |
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| Label | URL |
|---|---|
| UC, Irvine Medical Center - Dept of Neurosurgery's NPH webpage | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With External Lumbar Drain and Shunt Surg | All NPH patients shunted under this protocol have had a programmable valve inserted, either the Medtronic Strata valve, or the Codman-Hamim programmable valve. The valve pressure is set at the highest opening pressure at the time of implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects enrolled
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjective Comparisons Made for Patients - Before and After ex | Programmable Shunt Insertion (Codman, Medtronic): Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. Patient will be brought to operating room suite where general anesthesia is induced. Patient will be placed with a small roll on shoulder, supine, on the operating room table. Patient's head will be turned with the parietal area uppermost in the field. Patient will be prepared and draped in the usual sterile fashion. Site prep includes parietooccipital area, side of neck, chest, and entire abdomen. Ventricular catheter placed and then attached to shunt valve. Catheter is then fitted over grooved blue burr hole guide. Excess catheter pulled down to pull valve into pocket on the skull. Sterile dressings applied. Assessments in physical therapy, occupational therapy, and speech therapy: |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evans Ratio | A brain CT scan is obtained after the first week to ten days and the shunt is adjusted according to the patients signs and symptoms. Prior to any downward adjustment of the shunt valve (which allows more CSF drainage), a brain CT is obtained to look for subdural hematoma or effusion. If any type of subdural collection is found, the valve pressure is increased (to reduce CSF flow) until the collection resolves. | Insufficient number of participants were recruited to conduct qualitative analysis. The PI ended recruitment and left the university therefore no study data was produced. | Posted | initial and follow-up visits |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Comparison for Patients of Lumbar Drain and Shunt Surgery | Subjective comparisons made for patients - before and after external lumbar drain, before and after shunt surgery. Device: Programmable Shunt Insertion (Codman Medtronic) Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy Follow-up testing to be administered by trained physician assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, mini-mental status exam, 9-hole grooved pegboard, motor visual perception test (MVPT), modified rankin score (MRS) Programmable Shunt Insertion(Codman, Medtronic): Medical Device - Shunt insertion surgery of adjustable valve and laparoscopic assistance for placement of peritoneal catheter. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Nishi Clinical Trials Coordinator | University of California, Irvine | 949-824-3238 | cnishi@uci.edu |
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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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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| D009788 | Occupational Therapy |
| D013070 | Speech Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Assessments in physical therapy, occupational therapy, and speech therapy | Behavioral | Follow-up testing to be administered by trained Physician Assistant in the outpatient setting on an approximately monthly basis: 10m walk, timed up-and-go, Mini-Mental Status Exam, 9-hole Grooved Pegboard, Motor Visual Perception Test (MVPT), Modified Rankin Score (MRS) |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Secondary | Physical Therapy, Occupational Therapy, and Speech Therapy | The evaluations for physical therapy, occupational therapy and speech therapy are performed along with external lumbar drainage (ELD) to assess NPH subjects. | Insufficient number of subjects recruited for significant analysis. The PI ended recruitment and left the university therefore no study data was produced. | Posted | 30 min per clinic visit |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D005791 |
| Patient Care |
| D012049 | Rehabilitation of Speech and Language Disorders |