Spatial Neglect following Hemispheric stroke and focal brain injury MedDRA version: 14.0 Level: LLT Classification code 10050400 Term: Vigilance decreased System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.0 Level: PT Classification code 10029289 Term: Neurologic neglect syndrome System Organ Class: 10029205 - N
Conditions
Interventions
Product Name: Guanfacine
Pharmaceutical Form: Tablet
INN or Proposed INN: GUANFACINE
CAS Number: 29110472
Concentration unit: mg milligr
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 or more • Greater than 2 weeks following stroke • Ability to give consent • Evidence of robust Visual Neglect when tested twice with cancellation tasks and line bisection. Specifically, this includes: Overall score on cancellation tasks (Mesulam shape cancellation or BIT star cancellation) less then 75% total (with omissions on the left being 5 or more than omissions on the right) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Less than 2 weeks following stroke • Concomitant illness that may affect interpretation of any findings • Labile blood pressure following stroke • Systolic BP less than 100 mmHg and / or diastolic less than 70 mmHg • New antihypertensive medication started within last 2 weeks • Patients with hepatic or renal dysfunction Patients on neuroleptic medication • Patients with diagnosis of brain tumour • Patients with weight less than 55kg • Patients who are pregnant • Mothers who are breast feeding • Patients with severe coronary insufficiency or myocardial infarction within the previous 6 months • Cognitive impairment, dysphasia or dementia that prevents patient from giving informed consent • Severe mental impairment or physical handicap following stroke that prevents patients from giving consent or performing basic (standard clinical) tests for neglect
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establich whether spatial neglect and impaired sustained attention (secondary to hemispheric stroke or brain injury) are improved by a single dose of oral guanfacine;Secondary Objective: To establish whether improvement of neglect and sustained attention can only take place in patients with intact pre-frontal cortex;Primary end point(s): Completion of the 5 day trial period for each individual | — |
Countries
United Kingdom
Outcome results
None listed