Apraxia, IdeomotorNCT05259176
Effects of Transcranial Direct Current Electrical Stimulation on the Recovery of Ideomotor Apraxia of the Upper Limbs
A study testing transcranial Direct Current Stimulation (tDCS) and Behavioural in people with Apraxia, Ideomotor, run by Clinica di Riabilitazione Toscana Spa at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Apraxia, Ideomotor
- What is being tested?
- transcranial Direct Current Stimulation (tDCS) and Behavioural
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 2 Feb 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.);
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- Age between 20 and 80 years;
- Any schooling;
- Patient's informed consent signature.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
CLINICA DI RIABILITAZIONE TOSCANA Spa
Montevarchi, Arezzo, 52025
LAURA ABBRUZZESE, +39 3473333750, laura.abbruzzese@libero.it
CRISTIANO SCARSELLI, +39 3382985555, cristiano.scarselli@gmail.com
About this study
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
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
- Being tested
- transcranial Direct Current Stimulation (tDCS), Sham stimulation (sham-tDCS), Behavioural
- Keywords
- transcranial direct current stimulation, stroke rehabilitation
- Medical subject headings
- Apraxia, Ideomotor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
BehaviouralDevice
Treatment for upper limbs ideomotor apraxia (Smania et al., 2000)
| Study group | Role | What they receive |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS) | Experimental | transcranial Direct Current Stimulation (tDCS) on the left posterior parietal cortex and rehabilitative treatment with Smania's training Receives: Device: transcranial Direct Current Stimulation (tDCS); Device: Behavioural |
| Placebo stimulation (sham-tDCS) | Sham comparator | Placebo stimulation and rehabilitative treatment with Smania's training Receives: Device: Sham stimulation (sham-tDCS); Device: Behavioural |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The first day of treatment; End of 2nd week; End of 3rd week
Secondary outcomes (2)
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.
Measured: The first day of treatment; End of 2nd week; End of 3rd week
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.
Measured: The first day of treatment; End of 2nd week; End of 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start2 Feb 2022
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apraxia, IdeomotorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica di Riabilitazione Toscana Spa
- Sponsor type
- University, hospital or other
- Collaborators
- FONDAZIONE GIANFRANCO SALVINI ONLUS
- Responsible party
- Principal investigator, CRISTIANO SCARSELLI, Clinica di Riabilitazione Toscana Spa
- Investigators
- CRISTIANO SCARSELLI, Principal investigator, Clinica di Riabilitazione Toscana Spa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05259176
- Sponsor's protocol ID
- tDCS-AIM
- Status last verified
- Sep 2023
- First submitted
- 15 Feb 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05259176
- Acronym / sponsor ID
- tDCS-AIM
- Conditions
- Apraxia, Ideomotor
- Keywords
- transcranial direct current stimulation, stroke rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinica di Riabilitazione Toscana SpaUniversity, hospital or other
- Collaborators
- FONDAZIONE GIANFRANCO SALVINI ONLUS
- Study start
- 2 Feb 2022 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS) | Experimental | Device: transcranial Direct Current Stimulation (tDCS), Device: Behaviouraltranscranial Direct Current Stimulation (tDCS) on the left posterior parietal cortex and rehabilitative treatment with Smania's training |
| Placebo stimulation (sham-tDCS) | Sham comparator | Device: Sham stimulation (sham-tDCS), Device: BehaviouralPlacebo stimulation and rehabilitative treatment with Smania's training |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | transcranial Direct Current Stimulation (tDCS) |
| 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. | Device | Placebo stimulation (sham-tDCS) |
| BehaviouralTreatment for upper limbs ideomotor apraxia (Smania et al., 2000) | Device | Placebo stimulation (sham-tDCS), transcranial Direct Current Stimulation (tDCS) |
Primary outcome
Changes from baseline Ideomotor apraxia test
Time frame: 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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Changes from baseline Oral apraxia test
Time frame: The first day of treatment; End of 2nd week; End of 3rd week
Changes from baseline Jebsen-Taylor Hand Functional Assessment Scale
Time frame: The first day of treatment; End of 2nd week; End of 3rd week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CRISTIANO SCARSELLI principal investigator
Clinica di Riabilitazione Toscana Spa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS) and Behavioural in people with Apraxia, Ideomotor, run by Clinica di Riabilitazione Toscana Spa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LAURA ABBRUZZESE (3473333750, laura.abbruzzese@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline Ideomotor apraxia test (time frame: The first day of treatment; End of 2nd week; End of 3rd week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.