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

NCT05259176 | Unknown

• 1 other identifier: tDCS-AIM
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Apraxia, Ideomotor

Keywords

transcranial direct current stimulation; stroke rehabilitation

Outcome Measures

Primary Outcomes (3)

• Changes from baseline Ideomotor apraxia test

  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.

  The first day of treatment; End of 2nd week; End of 3rd week

• Changes from baseline Standardized test for the diagnosis of a selective ideomotor apraxia deficit on the basis of gesture and effector types

  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.

  The first day of treatment; End of 2nd week; End of 3rd week

• Changes from baseline Ideational apraxia test

  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.

  The first day of treatment; End of 2nd week; End of 3rd week

Secondary Outcomes (2)

• Changes from baseline Oral apraxia test

  The first day of treatment; End of 2nd week; End of 3rd week

• Changes from baseline Jebsen-Taylor Hand Functional Assessment Scale

  The first day of treatment; End of 2nd week; End of 3rd week

Study Arms (2)

transcranial Direct Current Stimulation (tDCS)

EXPERIMENTAL

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

Device: transcranial Direct Current Stimulation (tDCS); Device: Behavioural

Placebo stimulation (sham-tDCS)

SHAM COMPARATOR

Placebo stimulation and rehabilitative treatment with Smania's training

Device: Sham stimulation (sham-tDCS); Device: Behavioural

Interventions

transcranial Direct Current Stimulation (tDCS) DEVICE

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

transcranial Direct Current Stimulation (tDCS)

Sham stimulation (sham-tDCS) 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.

Placebo stimulation (sham-tDCS)

Behavioural DEVICE

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

Placebo stimulation (sham-tDCS); transcranial Direct Current Stimulation (tDCS)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica di Riabilitazione Toscana Spa: lead
• FONDAZIONE GIANFRANCO SALVINI ONLUS: collaborator

Study Sites (1)

CLINICA DI RIABILITAZIONE TOSCANA Spa

Montevarchi, Arezzo, 52025, Italy

RECRUITING

MeSH Terms

Conditions

Apraxia, Ideomotor

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Apraxias; Psychomotor Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• CRISTIANO SCARSELLI

  Clinica di Riabilitazione Toscana Spa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

LAURA ABBRUZZESE

CONTACT

3473333750; laura.abbruzzese@libero.it

CRISTIANO SCARSELLI

CONTACT

+39 3382985555; cristiano.scarselli@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Health Officer

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 28, 2022
• Study Start: February 2, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)