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
Secondary identifying numbers	N/A

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

Dr Ian K Pople
Scientific

Department of Neurosurgery
Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Phone	+44 (0)117 975 3960
Email	ikpople@hotmail.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/2002
Completion date	01/10/2003

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Not provided at time of registration
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

Department of Neurosurgery

Bristol
BS16 1LE
United Kingdom

The Frenchay Hydrocephalus Research Fund (UK)
Research organisation

Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

Website	http://www.nbt.nhs.uk/

Research organisation

The Frenchay Hydrocephalus Research Fund (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

24/05/2016: No publications found, verifying study status with principal investigator.