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
| ISRCTN | ISRCTN29863839 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29863839 |
| Protocol serial number | N/A |
| Sponsor | The Frenchay Hydrocephalus Research Fund (UK) |
| Funder | The Frenchay Hydrocephalus Research Fund (UK) |
- Submission date
- 17/10/2002
- Registration date
- 17/10/2002
- Last edited
- 24/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian K Pople
Scientific
Scientific
Department of Neurosurgery
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom
| Phone | +44 (0)117 975 3960 |
|---|---|
| ikpople@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2002 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Neurosurgery
Bristol
BS16 1LE
United Kingdom
BS16 1LE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
24/05/2016: No publications found, verifying study status with principal investigator.
