Back to resultsEffects of Transcranial Direct Current Electrical Stimulation on the Recovery of Ideomotor Apraxia of the Upper Limbs
Primary Purpose
Apraxia, Ideomotor
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
transcranial Direct Current Stimulation (tDCS)
Sham stimulation (sham-tDCS)
Behavioural
Sponsored by
About this trial
This is an interventional supportive care trial for Apraxia, Ideomotor focused on measuring transcranial direct current stimulation, stroke rehabilitation
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.
Sites / Locations
- CLINICA DI RIABILITAZIONE TOSCANA SpaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
transcranial Direct Current Stimulation (tDCS)
Placebo stimulation (sham-tDCS)
Arm Description
transcranial Direct Current Stimulation (tDCS) on the left posterior parietal cortex and rehabilitative treatment with Smania's training
Placebo stimulation and rehabilitative treatment with Smania's training
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Changes from baseline Oral apraxia test
The examiner mimics the 10 bucco-facial movements required by the protocol, and asks the patient to imitate them. If the subject does not perform the task or does not perform it correctly, the therapist repeats the gesture a second time. If, again, the patient does not perform or makes a mistake, the next stimulus is taken. Maximum time for each stimulus is 30 seconds. The gestures to imitate are: show your tongue, whistle, yawn, try to lick your nose, make a partridge, give a kiss, show how your teeth shake when it's cold, snap your tongue making the sound of a galloping horse, blow and scratch your throat. The score is 2 if the execution is accurate on the first attempt, 1 if it is correct on the second attempt and 0 if the gesture is not executed or is not reproduced correctly.
Changes from baseline Jebsen-Taylor Hand Functional Assessment Scale
It is a scale that allows to assess the level of hand function during daily activities. It consists of 7 subtests: writing, turning a page, lifting small objects, pantomime of eating, stacking objects, lifting large and light objects and large and heavy objects. The non-dominant hand will be tested first and then the dominant one. The time for each item will be timed: the final score (total time) will be given by the sum of all the part times: the lower the score, the better the level of hand function.
Full Information
NCT ID
NCT05259176
First Posted
February 15, 2022
Last Updated
September 6, 2023
Sponsor
Clinica di Riabilitazione Toscana Spa
Collaborators
FONDAZIONE GIANFRANCO SALVINI ONLUS
1. Study Identification
Unique Protocol Identification Number
NCT05259176
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica di Riabilitazione Toscana Spa
Collaborators
FONDAZIONE GIANFRANCO SALVINI ONLUS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apraxia, Ideomotor
Keywords
transcranial direct current stimulation, stroke rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcranial Direct Current Stimulation (tDCS)
Arm Type
Experimental
Arm Description
transcranial Direct Current Stimulation (tDCS) on the left posterior parietal cortex and rehabilitative treatment with Smania's training
Arm Title
Placebo stimulation (sham-tDCS)
Arm Type
Sham Comparator
Arm Description
Placebo stimulation and rehabilitative treatment with Smania's training
Intervention Type
Device
Intervention Name(s)
transcranial Direct Current Stimulation (tDCS)
Intervention Description
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
Intervention Name(s)
Sham stimulation (sham-tDCS)
Intervention Description
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
Intervention Name(s)
Behavioural
Intervention Description
Treatment for upper limbs ideomotor apraxia (Smania et al., 2000)
Primary Outcome Measure Information:
Title
Changes from baseline Ideomotor apraxia test
Description
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.
Time Frame
The first day of treatment; End of 2nd week; End of 3rd week
Title
Changes from baseline Standardized test for the diagnosis of a selective ideomotor apraxia deficit on the basis of gesture and effector types
Description
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.
Time Frame
The first day of treatment; End of 2nd week; End of 3rd week
Title
Changes from baseline Ideational apraxia test
Description
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.
Time Frame
The first day of treatment; End of 2nd week; End of 3rd week
Secondary Outcome Measure Information:
Title
Changes from baseline Oral apraxia test
Description
The examiner mimics the 10 bucco-facial movements required by the protocol, and asks the patient to imitate them. If the subject does not perform the task or does not perform it correctly, the therapist repeats the gesture a second time. If, again, the patient does not perform or makes a mistake, the next stimulus is taken. Maximum time for each stimulus is 30 seconds. The gestures to imitate are: show your tongue, whistle, yawn, try to lick your nose, make a partridge, give a kiss, show how your teeth shake when it's cold, snap your tongue making the sound of a galloping horse, blow and scratch your throat. The score is 2 if the execution is accurate on the first attempt, 1 if it is correct on the second attempt and 0 if the gesture is not executed or is not reproduced correctly.
Time Frame
The first day of treatment; End of 2nd week; End of 3rd week
Title
Changes from baseline Jebsen-Taylor Hand Functional Assessment Scale
Description
It is a scale that allows to assess the level of hand function during daily activities. It consists of 7 subtests: writing, turning a page, lifting small objects, pantomime of eating, stacking objects, lifting large and light objects and large and heavy objects. The non-dominant hand will be tested first and then the dominant one. The time for each item will be timed: the final score (total time) will be given by the sum of all the part times: the lower the score, the better the level of hand function.
Time Frame
The first day of treatment; End of 2nd week; End of 3rd week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LAURA ABBRUZZESE
Phone
3473333750
Email
laura.abbruzzese@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
CRISTIANO SCARSELLI
Phone
+39 3382985555
Email
cristiano.scarselli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CRISTIANO SCARSELLI
Organizational Affiliation
Clinica di Riabilitazione Toscana Spa
Official's Role
Principal Investigator
Facility Information:
Facility Name
CLINICA DI RIABILITAZIONE TOSCANA Spa
City
Montevarchi
State/Province
Arezzo
ZIP/Postal Code
52025
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAURA ABBRUZZESE
Phone
+39 3473333750
Email
laura.abbruzzese@libero.it
First Name & Middle Initial & Last Name & Degree
CRISTIANO SCARSELLI
Phone
+39 3382985555
Email
cristiano.scarselli@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Transcranial Direct Current Electrical Stimulation on the Recovery of Ideomotor Apraxia of the Upper Limbs
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