Dept. of Neurosurgery, Zurich University Hospital
Zurich, 8091, Switzerland
NCT Number: NCT04702035
20 patients who are diagnosed with NPH receive a set of 5 wearable gyroscopes (IMUs, ZurichMove sensors) for a period of 3 days for measurement and characterization of their walking in an ambulatory setting. At a follow-up 2 weeks to 6 months after CSF diversion surgery, the examination is repeated and improvement is measured. The data will be compared with a healthy group of 20 age- and gender-matched individuals as well a a group of 20 young individuals.
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Zurich, 8091, Switzerland
Temporary attachment of IMUs to wrists and ankles of the patients and probands for a period of three days and recording of movement during a 10 meter-walking test, 180° turnaround and during normal movement at home.
Group 1 (patients):
Patients with a completed diagnostic concerning iNPH, who are planned to receive a VP-shunt by their responsible neurosurgeon (independently from the study), will be included.
Before the shunt implantation, the patients will be examined at the USZ using wearable gyroscopes (like wristwatches) at both wrists and ankles as well as one around the body center.
The short examination will comprise a patient history (MoCa test, Kiefer-score, Stein- and Langfitt-Score), a short examination (4 minute walking test, 180° turnaround) in hospital. Afterwards, the patient goes home, where the gyroscopes examine walking patterns for a period of three days. After this period, the patient brings the devices back to the hospital. The surgery will take place afterwards, independently from the study, as well as adjustments of the shunt's flow-resistance for achievement of optimal response to the therapy. After this optimal result is achieved, but latest after 6 months, the examination will be repeated.
Groups 2 and 3 (controls):
As well 20 subjects matched for sex and age with the patient's group as 20 healthy young subjects will be examined just like the patients preoperatively. Walking patterns shall be compared to identify changes between pre- and postoperatively as well as differences between patients and controls.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Age limits for the NPH patient group and the matched healthy vonunteers group are 60-100 years.
Age limits for the young healthy volunteers group are 18-40 years.
Inclusion criteria
NPH patient group:
Matched controls group:
Young controls group:
Exclusion criteria
All participants receive a set of 5 wearable IMUs for a period of 3 days. The IMUs are fixed at both wrists, ankles and one over the sternum. A 10-meter walking test, 180 degree turnaround test and normal walking at home are performed. Afterwards, the IMUs are removed for data extraction and evaluation. The patient group is examined a second time after CSF diversion surgery.
Time frame: Between 2 weeks to 6 months after CSF diversion surgery
Complex walking pattern comprising of stride length, width, frequency (altogether one parameter)
Time frame: immediately after fixation of IMUs
Standard test (seconds)
Time frame: immediately after fixation of IMUs
Participants are asked to turn by 180 degrees. Steps needed are counted.
Time frame: before surgery
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Time frame: after surgery (range 2 weeks to 6 months)
Standard score for iNPH severity, only patient group; range 0-26; higher indicates higher severity
Time frame: before surgery
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
Time frame: after surgery (range 2 weeks to 6 months)
Standard score for patient independence, only patient group; range 0-IV; higher indicates higher dependency
Time frame: after surgery (range 2 weeks to 6 months)
Standard rate for success of CSF diversion treatment in NPH. Calculated as follows: (Kiefer score preoperatively - Kiefer score postoperatively) / Kiefer score preoperatively x 10; range 0-10; Higher indicates better response to surgery
Time frame: before surgery
Standard descriptor for width of lateral ventricles in iNPH. Calculated as maximum with of frontal horns / maximal diameter of brain in axial CT or MRI at the level of cella media; range: 0-1; higher indicates larger ventricles and more severe hydrocephlaus
Time frame: before surgery
Positivity of standard sign in preoperative CT or MRI imaging, hinting at presence of iNPH. Values: Positive/Negative
Time frame: before surgery
From first appearance of symptoms to surgery in years
Time frame: before surgery
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
Time frame: after surgery (range 2 weeks to 6 months)
Detailed analysis of walking patterns recorded during the measurement phases by the wearable IMUs.
University of Zurich
Other
Walking Pattern Characteristics in Normal Pressure Hydrocephalus. A Phase I/II Open-label Single Center Trial to Characterize Disease-specific Walking Patterns Using Wearable Gyroscopes
Acronym: NPH wearables
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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