Trial document



drksid header

  DRKS00012292

Trial Description

start of 1:1-Block title

Title

Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

RAdiCS

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012292
  •   2017/06/01
  •   2017/05/31
  •   yes
  •   Approved
  •   17-108, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1195-2536 
  •   NCT03185234  (ClinicalTrials.gov)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I63 -  Cerebral infarction
  •   Apraxia after left hemisphere stroke
  •   R48.2 -  Apraxia
end of 1:N-Block indications
start of 1:N-Block interventions

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.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

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).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/06/23
  •   110
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität zu Köln
    • 50924  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Mr.  Univ.-Prof. Dr. med.  Gereon R.  Fink 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Ms.  Dr. med.  Nina  Kleineberg 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Kognitive Neurologie, Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Mr.  Prof. Dr. med.  Peter H.  Weiss-Blankenhorn 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Neurologie, Uniklinik Köln,
    • Ms.  Dr. med.  Monika  Richter 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Neurologie, Uniklinik Köln,
    • Ms.  Natalie  Schloss 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Klinik und Poliklinik für Neurologie, Uniklinik Köln
    • Ms.  Katharina  Bolte 
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Uniklinik Köln
    • Kerpener Str. 62
    • 50924  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.