Effects of Transcranial Direct Current Electrical Stimulation on the Recovery of Ideomotor Apraxia of the Upper Limbs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-02

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Apraxia, Ideomotor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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transcranial Direct Current Stimulation (tDCS)

transcranial Direct Current Stimulation (tDCS) on the left posterior parietal cortex and rehabilitative treatment with Smania's training

Group Type EXPERIMENTAL

transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

Direct current transcranial stimulation will be applied for 20 minutes over the left posterior parietal cortex with an intensity set to 2 mA.

Behavioural

Intervention Type DEVICE

Treatment for upper limbs ideomotor apraxia (Smania et al., 2000)

Placebo stimulation (sham-tDCS)

Placebo stimulation and rehabilitative treatment with Smania's training

Group Type SHAM_COMPARATOR

Sham stimulation (sham-tDCS)

Intervention Type DEVICE

The same positioning of electrodes as the stimulation condition will be used, but the current will be applied for 30 seconds and then progressively reduced.

Behavioural

Intervention Type DEVICE

Treatment for upper limbs ideomotor apraxia (Smania et al., 2000)

Interventions

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transcranial Direct Current Stimulation (tDCS)

Direct current transcranial stimulation will be applied for 20 minutes over the left posterior parietal cortex with an intensity set to 2 mA.

Intervention Type DEVICE

Sham stimulation (sham-tDCS)

The same positioning of electrodes as the stimulation condition will be used, but the current will be applied for 30 seconds and then progressively reduced.

Intervention Type DEVICE

Behavioural

Treatment for upper limbs ideomotor apraxia (Smania et al., 2000)

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No