| Source of record | UK Trials |
| ISRCTN | ISRCTN29863839 |
| Date ISRCTN assigned | 17/10/2002 |
| Local reference number(s) | N/A |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Normal pressure hydrocephalus |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics information not required at time of registration. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/10/2002 |
| Anticipated end date | 01/10/2003 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Treatment group:
Endoscopic third ventriculostomy and choroid plexus coagulation.
Control group:
Programmable (Codman Medos valve) ventriculoperitoneal shunt. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | The Frenchay Hydrocephalus Research Fund |
| Sponsor name | The Frenchay Hydrocephalus Research Fund |
| Sponsor details | Frenchay Hospital
Frenchay Park Road
Bristol
United Kingdom
BS16 1LE |
| Sponsor telephone | +44 (0)117 970 1212 |
| Sponsor website | http://www.northbristol.nhs.uk/hospitals/Frenchay.asp |
| Contact name | Dr Ian K Pople |
| Contact details | Department of Neurosurgery
Frenchay Hospital
Frenchay Park Road
Bristol
United Kingdom
BS16 1LE |
| Contact telephone | +44 (0)117 975 3960 |
| Contact fax | +44 (0)117 970 1161 |
| Contact email | ikpople@hotmail.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN29863839 |
| Date last extracted from ISRCTN register | 17/04/2008 |
