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Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation (RAdiCS)

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ClinicalTrials.gov Identifier: NCT03185234
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gereon R. Fink, University of Cologne

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.

Condition or disease Intervention/treatment Phase
Stroke Apraxia Device: anodal tDCS Device: sham tDCS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall
Actual Study Start Date : June 23, 2017
Estimated Primary Completion Date : February 29, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: anodal tDCS
2 mA, 10 min, 5 sessions
Other Name: neuroConn DCS, model no. 008

Sham Comparator: Sham tDCS
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.
Device: sham tDCS
sham stimulation, 10 min, 5 sessions
Other Name: neuroConn DCS, model no. 008




Primary Outcome Measures :
  1. KAS (Cologne Apraxia Screening) [ Time Frame: 3-4 days after stimulation ]
    Degree of apraxia


Secondary Outcome Measures :
  1. KAS (Cologne Apraxia Screening) [ Time Frame: 3 months after enrollment ]
    Degree of apraxia

  2. Goldenberg Imitation [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Degree of apraxia

  3. de Renzi Imitation [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Degree of apraxia

  4. de Renzi actual tool use [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Degree of apraxia

  5. Action Research Arm Test (ARAT) [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Motor function

  6. Jebsen Taylor Hand Function Test (JTHFT) [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Motor function

  7. Gripforce (Vigorimeter) [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Motor function

  8. Strength of hands (MRC) [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Motor function

  9. National Institute of Health Stroke Scale (NIHSS) [ Time Frame: enrollment ]
    Impairment by stroke

  10. modified Ranking Scale (mRS) [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Impairment by stroke

  11. Aphasia Check List (ACL-K) [ Time Frame: 3-4 days after stimulation, and 3 months after enrollment ]
    Aphasia



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03185234


Contacts
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Contact: Gereon R. Fink, Univ-Prof. +49-221-478 4000 gereon.fink@uk-koeln.de

Locations
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Germany
Rehabilitationszentrum Godeshöhe e.V. Recruiting
Bonn, NRW, Germany, 53177
Contact: Karbe Hans, Prof.         
Sub-Investigator: Nina N. Kleineberg, MD         
Sub-Investigator: Monika K. Richter, MD         
Sub-Investigator: Peter H. Weiss, MD, Prof.         
Sub-Investigator: Juman Tutunji, MD         
MediClin Fachklinik Rhein/Ruhr für Neurologie Recruiting
Essen, NRW, Germany, 45219
Contact: Siebler Mario, Prof.         
Sub-Investigator: Monika K. Richter, MD         
Sub-Investigator: Nina N. Kleineberg, MD         
Sub-Investigator: Peter H. Weiss, MD, Prof.         
Sub-Investigator: Juman Tutunji, MD         
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Gereon R. Fink, Univ-Prof. University Hospital Cologne

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Responsible Party: Gereon R. Fink, Univ.-Prof. Dr. med., University of Cologne
ClinicalTrials.gov Identifier: NCT03185234     History of Changes
Other Study ID Numbers: Uni-Koeln-3033
U1111-1195-2536 ( Other Identifier: WHO )
DRKS00012292 ( Registry Identifier: DRKS )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gereon R. Fink, University of Cologne:
tDCS
Additional relevant MeSH terms:
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Stroke
Apraxias
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms