A Trial of Guanfacine, an Alpha 2 Adrenergic Agonist, for Spatial Neglect and Impaired Vigilance Following Stroke and Focal Brain Damage
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Performance on Tests of Hemispatial Neglect and Sustained Attention
研究概览
简要总结
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.
详细描述
The current study has a double-blind crossover design where patients will receive a single 2mg dose of oral guanfacine and a single dose of placebo. They will receive one of these on Day 2 of the study period and the other on Day 4.
They will be tested daily on Days 1 to 5 so that any test repetition or long-term drug effects can be gauged.
On days 2 and 4 they will be tested twice-once prior to drug/placebo administration and again 90 minutes after drug/placebo administration.
Tests will include standard pen-and-paper tasks for neglect as well as computerised tests of sustained attention and visual exploration. In our published pilot study (Malhotra et al, 2006) there was a suggestion that patients without damage to frontal cortex were more likely to respond to guanfacine. In the current study we intend to test 10 patients with and 10 patients without frontal damage in order to test this further.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Guanfacine (Day 2) then Placebo (Day 4)
All patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4.
干预措施: Guanfacine (Drug)
Guanfacine (Day 2) then Placebo (Day 4)
All patients received a single dose of guanfacine on Day 2 and a single dose of placebo on Day 4.
干预措施: Placebo (Drug)
Placebo (Day 2) then Guanfacine (Day 4)
All patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4.
干预措施: Guanfacine (Drug)
Placebo (Day 2) then Guanfacine (Day 4)
All patients received a single dose of placebo on Day 2 and a single dose of guanfacine on Day 4.
干预措施: Placebo (Drug)
结局指标
主要结局
Performance on Tests of Hemispatial Neglect and Sustained Attention
时间窗: 5 days
Touchscreen Cancellation: This is a computerised scale for measuring the severity of spatial neglect as described in previous publications (Malhotra et al, Annals of Neurology 2006; Parton et al, Neuroreport 2006). Patients are asked to find and touch targets (which are embedded amongst distractors) on a touchscreen. In the variant of the task employed here, the targets are not marked when touched ("Invisible Cancellation").The maximum number of targets that can be found is 64 (Therefore minimum score =0, maximum = 64), which represents normal performance.
次要结局
- Performance on Motor Tasks(5 Days)