Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus

NCT00613886 | Terminated Results

• 3 other identifiers: HS 2005-4609J&J Proposal #38973Award #032906
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Normal Pressure Hydrocephalus

Keywords

NPH; Normal Pressure Hydrocephalus

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Physical Therapy, Occupational Therapy, and Speech Therapy

  30 min per clinic visit

Study Arms (1)

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)

Device: Programmable Shunt Insertion (Codman, Medtronic); Behavioral: Assessments in physical therapy, occupational therapy, and speech therapy

Interventions

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.

Also known as: Codman Shunt, Medtronic Strata Valve

Comparison for patients of lumbar drain and shunt surgery

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)

Comparison for patients of lumbar drain and shunt surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Walking difficulties in both legs which has developed gradually, not explained by other conditions, either in combination with mental impairment and urinary incontinence
• Brain CT or MRI findings of enlarged ventricles compared to established standards (minimum Evans ratio of 0.30 as measured by reviewing films)
• Mental impairment must be mild to moderate, emerging with or after the walking difficulties
• Age \> or = 18 years old
• MMSE (Mini-mental status exam): \< or = 10
• Urinary incontinence

You may not qualify if:

• No or only minimal walking difficulties combined with severe dementia
• Severe medical problems with limited life expectancy (less than six months)
• Contraindications to surgery
• Lack of informed consent

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine - Medical Center

Orange, California, 92868, United States

Location

Related Links

• UC, Irvine Medical Center - Dept of Neurosurgery's NPH webpage

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure

Interventions

Physical Therapy Modalities; Occupational Therapy; Speech Therapy

Condition Hierarchy (Ancestors)

Hydrocephalus; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Rehabilitation of Speech and Language Disorders

Results Point of Contact

• Title: Chris Nishi Clinical Trials Coordinator
• Organization: University of California, Irvine

cnishi@uci.edu

949-824-3238

Study Officials

• Laura Pare, MD, FRCSC

  UC Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: February 13, 2008
• Study Start: March 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Locations

US (1)