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Completed

NCT Number: NCT03185234

Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitationszentrum Godeshöhe e.V., Bonn, North Rhine-Westphalia, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anodal tDCS

Device

2 mA, 10 min, 5 sessions

Other names: neuroConn DCS, model no. 008

Sham tDCS

Device

sham stimulation, 10 min, 5 sessions

Other names: neuroConn DCS, model no. 008

Primary outcomes

  1. KAS (Cologne Apraxia Screening)

    Time frame: 3-4 days after stimulation

    Degree of apraxia

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall

Acronym: RAdiCS

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2017
Registry last updated
May 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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