Trial document




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  DRKS00012292

Trial Description

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Title

Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation

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Trial Acronym

RAdiCS

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URL of the Trial

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Brief Summary in Lay Language

After left cerebral stroke, besides the actual hemiparesis, a deficit of higher motor cognition is frequently observed: apraxia. Apraxic patients suffer from deficits of the execution of complex actions and gestures; deficits which cannot be explained by hemiparesis only.
The objective of the clinical trial is to investigate whether weak direct current stimulation can ameliorate apraxic deficits in the rehabilitation of stroke patients. Therefore, two electrodes are attached to the scalp and a weak current is applied over the lesioned hemisphere to increase brain activity after stroke. The treatment is conducted for 10 minutes at a time on five consecutive days. Additionally, motor tasks shall be performed before and after the stimulation. The weak direct current stimulation is compared to a sham stimulation (placebo). The participant is assigned randomly to the two study groups (‘real’ direct current stimulation or sham stimulation). The effect of the weak current stimulation on apraxia is measured 3-4 days after the last stimulation and after 3 months. Secondary outcome measurements (assessing motor functions) are likewise conducted 3-4 days after the last stimulation and after 3 months.

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Brief Summary in Scientific Language

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 apraxia in left hemisphere stroke patients. Therefore anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2mA for 10 minutes at a time on five consecutive days. The treatment is combined with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Application of a pre-programmed study mode ensures a double-blind (patient and investigator) study design in regard to the applied stimulation (real tDCS versus sham). The primary endpoint is the apraxia score (KAS, Cologne Apraxia Screening) at 3-4 days after the last stimulation. A follow-up assessment is performed three months after the stimulation. Further outcome measurements - especially regarding motor function - are evaluated likewise after 3-4 days after the last stimulation and after 3 months.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012292
  •   2017/06/01
  •   2017/05/31
  •   yes
  •   Approved
  •   17-108, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1195-2536 
  •   NCT03185234  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   Apraxia after left hemisphere stroke
  •   R48.2 -  Apraxia
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Interventions/Observational Groups

  •   Real tDCS: 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.
  •   Sham tDCS (placebo): 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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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Degree of apraxia, measured 3-4 days after the last stimulation (evaluated by KAS, Cologne Apraxia Screening), compared to baseline.

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Secondary Outcome

In the post-interventional assessment 3-4 days after the last stimulation and after 3 months:

Degree of apraxia (measured by Goldenberg hand- and finger imitation; de Renzi imitation; de Renzi actual tool use),

Evaluation of strength (grip force vigorimeter; strength of hands by MRC-scale),

Extent of handicap (modified Ranking Scale, mRS),

Extent of aphasia (short version of Aphasia-Check-List).

After 3 months additionally:

Degree of apraxia (KAS, Cologne Apraxia Screening);

Movement function (Action Research Arm Test, ARAT; Jebsen-Taylor Hand Function Test, JTHFT).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/06/23
  •   110
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

Left hemispheric ischemic stroke in 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

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Exclusion Criteria

Pregnancy, breastfeeding and women without exclusion of pregnancy;
Patients with clinical manifestation of a stroke prior to the index-stroke;
malignant disease affecting the central nervous system;
epileptic seizure within the past two years;
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;
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 in electrode positions;
poor motivation/ cooperation

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Addresses

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    • Universität zu Köln
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Mr.  Univ.-Prof. Dr. med.  Gereon R.  Fink 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Ms.  Dr. med.  Nina  Kleineberg 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Kognitive Neurologie, Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Mr.  Prof. Dr. med.  Peter H.  Weiss-Blankenhorn 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln,
    • Ms.  Dr. med.  Monika  Richter 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln,
    • Ms.  Natalie  Schloss 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Ms.  Katharina  Bolte 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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