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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1195-2536 | Other Identifier | WHO | |
| DRKS00012292 | Registry Identifier | DRKS |
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The objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. Additionally, motor tasks are performed before and after the stimulation. The effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.
Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). The performance in the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. Secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real tDCS | Active Comparator | Anodal tDCS at an intensity of 2 mA is applied for 10 minutes at a time on 5 consecutive days. The anodal electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere, the cathodal electrode is located supraorbital on the right side. Motor tasks are performed before and after the stimulation. |
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| Sham tDCS | Sham Comparator | Sham stimulation is applied for 10 minutes at a time on 5 consecutive days. One electrode is placed over the left parietal cortex (P3 in 10/20 EEG) of the lesioned hemisphere and a second electrode supraorbital on the right side. Motor tasks are performed before and after the stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anodal tDCS | Device | 2 mA, 10 min, 5 sessions |
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| Measure | Description | Time Frame |
|---|---|---|
| KAS (Cologne Apraxia Screening) | Degree of apraxia | 3-4 days after stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| KAS (Cologne Apraxia Screening) | Degree of apraxia | 3 months after enrollment |
| Goldenberg Imitation | Degree of apraxia | 3-4 days after stimulation, and 3 months after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gereon R. Fink, Univ-Prof. | University Hospital Cologne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rehabilitationszentrum Godeshöhe e.V. | Bonn | North Rhine-Westphalia | 53177 | Germany | ||
| MediClin Fachklinik Rhein/Ruhr für Neurologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33324913 | Derived | Kleineberg NN, Richter MK, Becker I, Weiss PH, Fink GR. Verum versus sham tDCS in the treatment of stroke-induced apraxia: study protocol of the randomized controlled trial RAdiCS -"Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation". Neurol Res Pract. 2020 Mar 4;2:7. doi: 10.1186/s42466-020-0052-y. eCollection 2020. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D001072 | Apraxias |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| sham tDCS | Device | sham stimulation, 10 min, 5 sessions |
|
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| de Renzi Imitation | Degree of apraxia | 3-4 days after stimulation, and 3 months after enrollment |
| de Renzi actual tool use | Degree of apraxia | 3-4 days after stimulation, and 3 months after enrollment |
| Action Research Arm Test (ARAT) | Motor function | 3-4 days after stimulation, and 3 months after enrollment |
| Jebsen Taylor Hand Function Test (JTHFT) | Motor function | 3-4 days after stimulation, and 3 months after enrollment |
| Gripforce (Vigorimeter) | Motor function | 3-4 days after stimulation, and 3 months after enrollment |
| Strength of hands (MRC) | Motor function | 3-4 days after stimulation, and 3 months after enrollment |
| National Institute of Health Stroke Scale (NIHSS) | Impairment by stroke | enrollment |
| modified Ranking Scale (mRS) | Impairment by stroke | 3-4 days after stimulation, and 3 months after enrollment |
| Aphasia Check List (ACL-K) | Aphasia | 3-4 days after stimulation, and 3 months after enrollment |
| Essen |
| North Rhine-Westphalia |
| 45219 |
| Germany |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |