Effects of Transcranial Direct Current Electrical Stimulation (tDCS) on the Recovery of Ideomotor Apraxia of the Upper Limbs in Patients With Acute Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes from baseline Ideomotor apraxia test
研究概览
简要总结
Limbs apraxia is a motor disorder whose characteristic is the inability or difficulty to perform intentional movements of the limbs (gestures), most frequently involving the upper limbs. Recent literature indicated promising effects of transcranial direct current stimulation (tDCS) in the recovery of limbs apraxia, showing that, in stroke patients, excitatory anodal tDCS over left inferior parietal lobe (IPL) may improve limb apraxia. Despite this encouraging evidence, the need for larger well powered and sham-controlled clinical trials has also been identified. For these reasons, the objective of this study is to investigate the effects of tDCS application on the left posterior parietal cortex, associated with the treatment for apraxia made by Smania et al. in 2000, on the recovery of the upper limbs ideomotor apraxia in patients with left brain lesion of vascular origin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both gender, with ischaemic stroke;
- •Left hemispheric injury documented by neuroimaging examination;
- •Cerebrovascular disease onset within the first 30 days;
- •Presence of ideomotor apraxia as documented by a score < 53 in the De Renzi's test;
- •Intact semantic skills as documented by normal performance on the Auditory or Visual Word Comprehension subtest of the Neuropsychological Examination for Aphasia (E. N. P. A.);
- •Full comprehension skills as documented by normal performance in the sub-test of oral or orthographic comprehension (Auditory or Visual Words Comprehension) of the Neuropsychological Examination for Aphasia (E. N. P. A.);
- •Age between 20 and 80 years;
- •Any schooling;
- •Patient's informed consent signature.
排除标准
- •Comprehension and/or semantics deficit as documented by E. N. P. A.;
- •Pre-existing psychiatric and/or neurological pathology;
- •Failure to sign the patient's and/or caregiver's informed consent.
结局指标
主要结局
Changes from baseline Ideomotor apraxia test
时间窗: The first day of treatment; End of 2nd week; End of 3rd week
It consists of 24 imitation tests carried out with the fingers, the hand and the limb homolateral to the lesion. Each gesture is presented up to three times if the production is incorrect, and receives a score of 3 to 0 depending on whether the copy is correct the first, the second, the third time, or never. The test includes 24 gestures, 12 symbolic and 12 non-symbolic, for a total score of 72. Application of the test to over 200 normal subjects showed that the diagnosis of apraxia can be made reliably when the score drops below 53, it's probable, but not certain, for a score between 53 and 62, and it's excluded when the score is greater than 62.
Changes from baseline Standardized test for the diagnosis of a selective ideomotor apraxia deficit on the basis of gesture and effector types
时间窗: The first day of treatment; End of 2nd week; End of 3rd week
Test for ideomotor apraxia assessment which allows to highlight: 1) the selective deficits for the type of gesture to be imitated and, therefore, specific damage to the two processes underlying the imitation (direct route and semantic pathways) presenting known and new gestures in separate blocks; and 2) deficits of the distal or proximal component of the movements.
Changes from baseline Ideational apraxia test
时间窗: The first day of treatment; End of 2nd week; End of 3rd week
By placing in front of the patient one object at a time, he is asked to perform the pantomime of use of the object without touching or holding the object itself, but only by looking at it (visual mode). The examiner will assign 2 points if the execution is correct, 1 point if the execution is correct after repetition of the command and 0 points for always incorrect execution. The objects used are: glass, screwdriver, comb, gun, fork, key, rubber, saw, hammer, fan.
次要结局
- Changes from baseline Jebsen-Taylor Hand Functional Assessment Scale(The first day of treatment; End of 2nd week; End of 3rd week)
- Changes from baseline Oral apraxia test(The first day of treatment; End of 2nd week; End of 3rd week)
研究者
CRISTIANO SCARSELLI
Deputy Chief Health Officer
Clinica di Riabilitazione Toscana Spa