Trial Outcomes & Findings for Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus (NCT NCT00613886)
NCT ID: NCT00613886
Last Updated: 2021-01-12
Results Overview
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.
TERMINATED
NA
24 participants
initial and follow-up visits
2021-01-12
Participant Flow
Participant milestones
| Measure |
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
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|---|---|
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Overall Study
STARTED
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24
|
|
Overall Study
COMPLETED
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0
|
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Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Factors Predicting Response to Shunting in Normal Pressure Hydrocephalus
Baseline characteristics by cohort
| Measure |
Subjective Comparisons Made for Patients - Before and After ex
n=24 Participants
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:
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: initial and follow-up visitsPopulation: Insufficient number of participants were recruited to conduct qualitative analysis. The PI ended recruitment and left the university therefore no study data was produced.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 min per clinic visitPopulation: Insufficient number of subjects recruited for significant analysis. The PI ended recruitment and left the university therefore no study data was produced.
The evaluations for physical therapy, occupational therapy and speech therapy are performed along with external lumbar drainage (ELD) to assess NPH subjects.
Outcome measures
Outcome data not reported
Adverse Events
Comparison for Patients of Lumbar Drain and Shunt Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Chris Nishi Clinical Trials Coordinator
University of California, Irvine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place