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ISRCTN
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ISRCTN29863839
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ClinicalTrials.gov identifier
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Public title
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A prospective, randomised, controlled trial to evaluate the efficacy and safety of endoscopic choroid plexus coagulation with third ventriculostomy in the treatment of idiopathic Normal Pressure Hydrocephalus
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Normal Pressure Hydrocephalus (NPH)
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Participants - inclusion criteria
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1. A clinical diagnosis of Normal Pressure Hydrocephalus (NPH) by the following criteria:
a. Evidence of significant gait disturbance in the absence of other causative factors
b. Evidence of some cognitive impairment on formal neuropsychological testing (Mattis dementia rating scale and Folstein mini-mental state examination) and/or urinary incontinence or evidence of neurogenic urinary disturbance (frequency or urgency)
c. Lumbar Opening Pressure less than 20 mmHg on supine lumbar puncture
2. Symptom duration of more than six months
3. Evidence of disease progression since onset of symptoms
4. Radiological evidence of hydrocephalus, Evans ratio more than 0.3 on Computed Tomography (CT) scan of head
5. Patients must be fit enough to undergo operative surgical treatment, as defined by an American Society of Anesthesiologists (ASA) score of one, two or three
6. Written informed consent to participation in the study obtained from the patient, or next of kin if the patient is unable (due to cognitive impairment) to give informed consent
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/2002
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Anticipated end date
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01/10/2003
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Treatment group: Endoscopic third ventriculostomy and choroid plexus coagulation.
Control group: Programmable (Codman Medos valve) ventriculoperitoneal shunt.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Frenchay Hydrocephalus Research Fund (UK)
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Trial website
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Publications
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Contact name
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Dr
Ian K
Pople
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Address
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Department of Neurosurgery
Frenchay Hospital
Frenchay Park Road
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City/town
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Bristol
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Zip/Postcode
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BS16 1LE
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Country
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United Kingdom
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Tel
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+44 (0)117 975 3960
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Fax
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+44 (0)117 970 1161
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Email
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ikpople@hotmail.com
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Sponsor
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The Frenchay Hydrocephalus Research Fund (UK)
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Address
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Frenchay Hospital
Frenchay Park Road
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City/town
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Bristol
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Zip/Postcode
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BS16 1LE
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Country
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United Kingdom
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Tel
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+44 (0)117 970 1212
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Email
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Sponsor website:
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http://www.nbt.nhs.uk/
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Date applied
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17/10/2002
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Last edited
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28/01/2010
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Date ISRCTN assigned
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17/10/2002
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