Contact information
Type
Scientific
Primary contact
Dr Ian K Pople
ORCID ID
Contact details
Department of Neurosurgery
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
+44 (0)117 975 3960
ikpople@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Normal Pressure Hydrocephalus (NPH)
Intervention
Treatment group: Endoscopic third ventriculostomy and choroid plexus coagulation.
Control group: Programmable (Codman Medos valve) ventriculoperitoneal shunt.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/10/2002
Overall trial end date
01/10/2003
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/10/2002
Recruitment end date
01/10/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Neurosurgery
Bristol
BS16 1LE
United Kingdom
Sponsor information
Organisation
The Frenchay Hydrocephalus Research Fund (UK)
Sponsor details
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Frenchay Hydrocephalus Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary