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
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

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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNormal Pressure Hydrocephalus (NPH)
InterventionTreatment group: Endoscopic third ventriculostomy and choroid plexus coagulation.
Control group: Programmable (Codman Medos valve) ventriculoperitoneal shunt.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/10/2002
Completion date01/10/2003

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/10/2002
Date of final enrolment01/10/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Neurosurgery
Bristol
BS16 1LE
United Kingdom

Sponsor information

The Frenchay Hydrocephalus Research Fund (UK)
Research organisation

Frenchay Hospital
Frenchay Park Road
Bristol
BS16 1LE
United Kingdom

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

Funders

Funder type

Research organisation

The Frenchay Hydrocephalus Research Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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