Normal Pressure Hydrocephalus Clinical Trial
— ARCS NPHOfficial title:
Efficacy of Shunt Surgery in Normal Pressure Hydrocephalus: a Randomized Cross-over Study
Verified date | October 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of our study is to verify the effectiveness of the shunt and to identify the most sensitive criteria to select patients for surgery. The study is designed to assess improvement in walking and balance (gait), urinary function and memory after shunting. In addition, the study aims to identify the most accurate and sensitive tools to measure improvement for our patients.
Status | Completed |
Enrollment | 48 |
Est. completion date | September 14, 2017 |
Est. primary completion date | September 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Age of Patients ( between 60 to 85 years old) - Clinically suspected Normal Pressure Hydrocephalus (NPH) with at least gait impairment - Informed consent from patient Exclusion Criteria: - Etiology for hydrocephalus other than idiopathic normal pressure hydrocephalus - Patients not capable of providing an informed consent. - History of intra-cerebral hemorrhage - Cardiac Pacemaker |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Ohio State University | Columbus | Ohio |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Rhode Island Hospital | Providence | Rhode Island |
United States | Virgina Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Aesculap, Inc., Henry Ford Health System, Ohio State University, Rhode Island Hospital, Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tinetti Score on Open Shunt vs. Closed Shunt | 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. | 6 weeks | |
Primary | Timed Up and Go (TUG) Score on Open Shunt vs. Closed Shunt | 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. | 6 weeks | |
Primary | Medical College of Virginia (MCV) Gait Grade on Open Shunt vs. Closed Shunt | The MCV gait grade evaluation measures balance and walking. The score ranges from 1 to 6 with higher values suggesting worse gait performance. | 6 weeks | |
Primary | Kiefer Score on Open Shunt vs. Closed Shunt | 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 | 6 weeks | |
Primary | Kubo Score on Open Shunt vs. Closed Shunt | 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 | 6 weeks |
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