Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance
Condition: Stroke; Hemispatial Neglect
MeSH terms: Stroke; Perceptual Disorders
Intervention: Guanfacine; Placebo
Intervention description: 2mg oral guanfacine (encapsulated); placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients were tested on five consecutive days. On days 1, 3 and 5, they were tested on a task battery. On day 2, individuals received active drug or placebo, and on day 4 they received placebo if they had previously received active drug and vice versa. The order of administration of guanfacine and placebo was counterbalanced across patients, according to a pregenerated randomisation scheme. The clinician who administered the drugs and the tests was blind to the randomisation and the drug. The analyses presented here were performed by a different researcher, only after all data were collected. On both treatment days, patients were tested on the task battery twice: once immediately before guanfacine/placebo administration and once 2 hours after.
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The order of administration of guanfacine and placebo was counterbalanced across patients, according to a pregenerated randomisation scheme. The clinician who administered the drugs and the tests was blind to the randomisation and the drug.
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neglect; Attention; Vigilance; Stroke; Hemineglect; Unilateral Neglect; Spatial Neglect

Summary:

      To find out if spatial neglect following stroke and brain injury can be reduced using
      guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous
      pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined
      in a larger number of patients, and there will also be a systematic assessment of whether the
      drug is only effective in patients with particular patterns of brain damage.
    

Eligibility 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.

        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 3 weeks

          -  Patients with hepatic or renal dysfunction

          -  Patients receiving other medications known to potentiate guanfacine's antihypertensive
             and hypotensive effects or cause torsade de pointes, specifically antipsychotics
             (including sultopride, chlorpromazine, thioridazine, amisulpiride, sulpiride,
             haloperidol), and moxifloxacin, baclofen, verapamil, quinidine, hydroquinidine,
             dispyramide, amiodarone, dofetilide, ibutilide, sotalol, pimozide, bepridil,
             cisapride, diphemanil, erythromycin IV, halofantrine, pentamidine, sparfloxacin,
             vincamine, alfuzosin, prazosin, terazosin, tamsulosin, amifostine

          -  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 in 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