Trial Outcomes & Findings for A Randomized Cross-over Study for Normal Pressure Hydrocephalus (NCT NCT01798641)

Last Updated: 2018-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

6 weeks

Results posted on

2018-11-02

Participant Flow

10 patients (5 from each group) were excluded from the study as further assessment prior to randomization showed significant risk of falls

Participant milestones

Participant milestones
Measure	Open Shunt, Then Closed 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.	Closed Shunt, Then 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.
First Intervention (6 Weeks) STARTED	19	19
First Intervention (6 Weeks) COMPLETED	19	19
First Intervention (6 Weeks) NOT COMPLETED	0	0
Second Intervention (6 Weeks) STARTED	19	19
Second Intervention (6 Weeks) COMPLETED	19	19
Second Intervention (6 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Cross-over Study for Normal Pressure Hydrocephalus

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 6 weeks

Population: Only 10 participants were analyzed from each group. The rest were lost to follow up

Outcome measures

Outcome measures
Measure	Open Shunt n=10 Participants 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.	Closed Shunt n=10 Participants 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.
Tinetti Score on Open Shunt vs. Closed Shunt	24.50 score on a scale Interval 23.0 to 27.2	26.50 score on a scale Interval 24.5 to 27.0

PRIMARY outcome

Timeframe: 6 weeks

Population: 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

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.

Outcome measures

Outcome measures
Measure	Open Shunt n=7 Participants 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.	Closed Shunt n=10 Participants 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.
Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt	12.0 seconds Interval 10.0 to 13.7	10.5 seconds Interval 8.38 to 15.53

PRIMARY outcome

Timeframe: 6 weeks

Population: Only 8 from each closed shunt group were analyzed. The rest were lost to follow up

The MCV gait grade evaluation measures balance and walking. The score ranges from 1 to 6 with higher values suggesting worse gait performance.

Outcome measures

Outcome measures
Measure	Open Shunt n=8 Participants 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.	Closed Shunt n=8 Participants 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.
Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt	3.00 score on a scale Interval 2.0 to 3.0	1.50 score on a scale Interval 1.0 to 3.0

PRIMARY outcome

Timeframe: 6 weeks

Population: Only 11 participants were analyzed from each arm. The remaining were lost to follow up

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

Outcome measures

Outcome measures
Measure	Open Shunt n=11 Participants 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.	Closed Shunt n=11 Participants 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.
Kiefer Score on Open Shunt vs. Closed Shunt	4 score on a scale Interval 3.0 to 6.0	5 score on a scale Interval 2.0 to 7.0

PRIMARY outcome

Timeframe: 6 weeks

Population: Only 11 participants were analyzed from each group. The rest were lost to follow up.

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

Outcome measures

Outcome measures
Measure	Open Shunt n=11 Participants 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.	Closed Shunt n=11 Participants 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.
Kubo Score on Open Shunt vs. Closed Shunt	3 score on a scale Interval 2.0 to 3.0	4 score on a scale Interval 2.0 to 6.0

Adverse Events

Open Shunt

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Closed Shunt

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Open Shunt n=38 participants at risk 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.	Closed Shunt n=38 participants at risk 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.
Surgical and medical procedures subdural hematoma	7.9% 3/38 • Number of events 3 • 1 year	0.00% 0/38 • 1 year
Surgical and medical procedures hygroma	2.6% 1/38 • Number of events 1 • 1 year	0.00% 0/38 • 1 year

Additional Information

Dr. Daniele Rigamonti, MD FACS

Johns Hopkins University

Phone: 410-955-2259

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Open Shunt, Then Closed n=19 Participants 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.	Closed Shunt, Then Open n=19 Participants 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 n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants