Clinical trial NCT03185234: Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation
Official title: Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Apraxia
Keywords: tDCS
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* left hemispheric ischemic stroke in the subacute/ chronic phase (\>10 days and \<180 days post-stroke)
* clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;
* age 18 - 90 years;
* written Informed Consent

Exclusion Criteria:

* pregnancy, breastfeeding and women without exclusion of pregnancy
* patients with clinical manifestation of a stroke prior to the index-stroke
* malignant disease with affection of central nervous system
* life expectancy \<12 months
* current addiction to alcohol or drugs or other addictive disease (exception: nicotine)
* current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode
* epileptic seizure within the past two years
* continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures
* enrollment in other studies with brain stimulation in the time period after the index stroke
* heart pacemaker
* electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)
* craniectomy or trepanation
* vulnerable skin lesions at electrode positions
* poor motivation/ cooperation

Primary outcomes:
measure: KAS (Cologne Apraxia Screening)
timeFrame: 3-4 days after stimulation
Secondary outcomes:
measure: KAS (Cologne Apraxia Screening)
timeFrame: 3 months after enrollment
measure: Goldenberg Imitation
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: de Renzi Imitation
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: de Renzi actual tool use
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: Action Research Arm Test (ARAT)
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: Jebsen Taylor Hand Function Test (JTHFT)
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: Gripforce (Vigorimeter)
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: Strength of hands (MRC)
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: enrollment
measure: modified Ranking Scale (mRS)
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
measure: Aphasia Check List (ACL-K)
timeFrame: 3-4 days after stimulation, and 3 months after enrollment
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Rehabilitationszentrum Godeshöhe e.V.
state: NRW
city: Essen
country: Germany
facility: MediClin Fachklinik Rhein/Ruhr für Neurologie
state: NRW
Study officials:
affiliation: University Hospital Cologne
name: Gereon R. Fink, Univ-Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.