Condition category
Nervous System Diseases
Date applied
17/10/2002
Date assigned
17/10/2002
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

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

Publication citations

Additional files

Editorial Notes

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