Clinical trial NCT05259176: Effects of Transcranial Direct Current Electrical Stimulation on the Recovery of Ideomotor Apraxia of the Upper Limbs
Official title: Effects of Transcranial Direct Current Electrical Stimulation (tDCS) on the Recovery of Ideomotor Apraxia of the Upper Limbs in Patients With Acute Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apraxia, Ideomotor
Keywords: transcranial direct current stimulation
stroke rehabilitation
Lead sponsor: Clinica di Riabilitazione Toscana Spa
Sponsor class: OTHER
Collaborators: name: FONDAZIONE GIANFRANCO SALVINI ONLUS
First posted: 2022-02-28
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The present study will be conducted in 2 recruiting centers with a randomized double-blind design. Post-stroke patients with apraxia will be randomly allocated into two parallel groups (Group A and Group B) by creating two randomisation lists of 10 patients which will allow for random and balanced assignment of patient numbers to either Group A or Group B. Group A will undergo direct current transcranial stimulation (tDCS) for 10 consecutive days and online treatment with Smania training. Group B will undergo sham stimulation for 10 consecutive days and online treatment with Smania training.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes from baseline Ideomotor apraxia test
timeFrame: The first day of treatment; End of 2nd week; End of 3rd week
measure: Changes from baseline Standardized test for the diagnosis of a selective ideomotor apraxia deficit on the basis of gesture and effector types
timeFrame: The first day of treatment; End of 2nd week; End of 3rd week
measure: Changes from baseline Ideational apraxia test
timeFrame: The first day of treatment; End of 2nd week; End of 3rd week
Secondary outcomes:
measure: Changes from baseline Oral apraxia test
timeFrame: The first day of treatment; End of 2nd week; End of 3rd week
measure: Changes from baseline Jebsen-Taylor Hand Functional Assessment Scale
timeFrame: The first day of treatment; End of 2nd week; End of 3rd week
Other outcomes:
Locations:
city: Montevarchi
country: Italy
facility: CLINICA DI RIABILITAZIONE TOSCANA Spa
state: Arezzo
Study officials:
affiliation: Clinica di Riabilitazione Toscana Spa
name: CRISTIANO SCARSELLI
role: PRINCIPAL_INVESTIGATOR
References: