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A Randomized Cross-over Study for Normal Pressure Hydrocephalus (ARCS NPH)

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ClinicalTrials.gov Identifier: NCT01798641
Recruitment Status : Completed
First Posted : February 26, 2013
Results First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Collaborators:
Aesculap, Inc.
Ohio State University
Rhode Island Hospital
Virginia Commonwealth University
Henry Ford Health System
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Normal Pressure Hydrocephalus
Intervention Device: MIETHKE proGAV® / MIETHKE proSA®
Enrollment 48

Recruitment Details  
Pre-assignment Details 10 patients (5 from each group) were excluded from the study as further assessment prior to randomization showed significant risk of falls
Arm/Group Title Open Shunt, Then Closed Closed Shunt, Then Open
Hide Arm/Group Description

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open.

Period Title: First Intervention (6 Weeks)
Started 19 19
Completed 19 19
Not Completed 0 0
Period Title: Second Intervention (6 Weeks)
Started 19 19
Completed 19 19
Not Completed 0 0
Arm/Group Title Open Shunt, Then Closed Closed Shunt, Then Open Total
Hide Arm/Group Description

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks.The closed shunt will be adjusted to open.

Total of all reporting groups
Overall Number of Baseline Participants 19 19 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  10.5%
4
  21.1%
6
  15.8%
>=65 years
17
  89.5%
15
  78.9%
32
  84.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Female
6
  31.6%
11
  57.9%
17
  44.7%
Male
13
  68.4%
8
  42.1%
21
  55.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
19
 100.0%
19
 100.0%
38
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 19 participants 38 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
19
 100.0%
19
 100.0%
38
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Tinetti Score on Open Shunt vs. Closed Shunt
Hide Description The Tinetti tool test measures walking and balance. It is designed to determine an elders risk for falls within the next year. It takes about 8-10 minutes to complete. The patient is asked to complete the gait portion first with the evaluator walking close behind the elder and evaluating gait steppage and drift. The patient is then asked to complete the balance portion with the evaluator again standing close by the patient (towards the right and in front). The patient is then asked to sit and the score is then totaled.The higher the score, the better the performance. Scoring is done on a three point scale with a range on each item of 0-2 with 0 representing the most impairment. Individual scores are then combined to form three scales: a Gait Scale, a Balance Scale and then and overall Gait and Balance score. The maximum score for gait is 12 points while the maximum for Balance is 16 points with a total maximum for the overall score of 28 points.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 10 participants were analyzed from each group. The rest were lost to follow up
Arm/Group Title Open Shunt Closed Shunt
Hide Arm/Group Description:

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open.

Overall Number of Participants Analyzed 10 10
Mean (Inter-Quartile Range)
Unit of Measure: score on a scale
24.50
(23.00 to 27.20)
26.50
(24.50 to 27.00)
2.Primary Outcome
Title Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt
Hide Description The TUG evaluation measures walking and balance. The patient is timed while they rise from an arm chair (approximate seat height 46 cm), walk at a comfortable and safe pace to a line on the floor three meters away, turn and walk back to the chair and sit down again. The patient walks through the test once before being timed to become familiar with the test. The subject wears his regular footwear and uses a walking aid (cane or walker) if necessary. A faster time indicates a better functional performance and a score of ≥13.5 seconds is used as a cut-point to identify those at increased risk of falls.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 7 participants were analyzed from the open shunt group. Only 10 were analyzed from the closed shunt group. The rest were lost to follow up
Arm/Group Title Open Shunt Closed Shunt
Hide Arm/Group Description:

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open.

Overall Number of Participants Analyzed 7 10
Median (Inter-Quartile Range)
Unit of Measure: seconds
12.0
(10.00 to 13.70)
10.5
(8.38 to 15.53)
3.Primary Outcome
Title Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt
Hide Description The MCV gait grade evaluation measures balance and walking. The score ranges from 1 to 6 with higher values suggesting worse gait performance.
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 8 from each closed shunt group were analyzed. The rest were lost to follow up
Arm/Group Title Open Shunt Closed Shunt
Hide Arm/Group Description:

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks.The closed shunt will be adjusted to open.

Overall Number of Participants Analyzed 8 8
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3.00
(2.00 to 3.00)
1.50
(1.00 to 3.00)
4.Primary Outcome
Title Kiefer Score on Open Shunt vs. Closed Shunt
Hide Description The Kiefer is a modified clinical grading tool that measures the severity of the three key symptoms (mental deficits, gait disturbance, incontinence) and two additional minor symptoms (headache and dizziness). The overall score may reach values between 0 and 24, with higher scores indicating more severe impairment
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 11 participants were analyzed from each arm. The remaining were lost to follow up
Arm/Group Title Open Shunt Closed Shunt
Hide Arm/Group Description:

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open.

Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
4
(3 to 6)
5
(2 to 7)
5.Primary Outcome
Title Kubo Score on Open Shunt vs. Closed Shunt
Hide Description The Kubo tool measures your symptoms in three categories: cognitive (attention and memory), gait/balance and urinary function.The score ranges from 0 to 24 with higher scores indicating worse symptoms
Time Frame 6 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 11 participants were analyzed from each group. The rest were lost to follow up.
Arm/Group Title Open Shunt Closed Shunt
Hide Arm/Group Description:

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open.

Overall Number of Participants Analyzed 11 11
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3
(2 to 3)
4
(2 to 6)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Shunt Closed Shunt
Hide Arm/Group Description

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be open at this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed.

The programmable valve, MIETHKE proGAV® / MIETHKE proSA®, will be closed during this time. The adjustment is done in the out-patient clinic.

MIETHKE proGAV® / MIETHKE proSA®: The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The closed shunt will be adjusted to open.

All-Cause Mortality
Open Shunt Closed Shunt
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/38 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Open Shunt Closed Shunt
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/38 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Open Shunt Closed Shunt
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/38 (10.53%)      0/38 (0.00%)    
Surgical and medical procedures     
subdural hematoma *  3/38 (7.89%)  3 0/38 (0.00%)  0
hygroma *  1/38 (2.63%)  1 0/38 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Daniele Rigamonti, MD FACS
Organization: Johns Hopkins University
Phone: 410-955-2259
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01798641     History of Changes
Other Study ID Numbers: NA_00042178
First Submitted: January 31, 2013
First Posted: February 26, 2013
Results First Submitted: August 17, 2018
Results First Posted: November 2, 2018
Last Update Posted: November 2, 2018