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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Anodal tDCS Device
    Intervention Desc: 2 mA, 10 min, 5 sessions
    ARM 1: Kind: Experimental
    Label: Real tDCS
    Description: 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 Device
    Intervention Desc: sham stimulation, 10 min, 5 sessions
    ARM 1: Kind: Experimental
    Label: Sham tDCS
    Description: 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary KAS (Cologne Apraxia Screening) 3-4 days after stimulation
Secondary Goldenberg Imitation 3-4 days after stimulation, and 3 months after enrollment
Secondary de Renzi Imitation 3-4 days after stimulation, and 3 months after enrollment
Secondary de Renzi actual tool use 3-4 days after stimulation, and 3 months after enrollment
Secondary Action Research Arm Test (ARAT) 3-4 days after stimulation, and 3 months after enrollment
Secondary Jebsen Taylor Hand Function Test (JTHFT) 3-4 days after stimulation, and 3 months after enrollment
Secondary Gripforce (Vigorimeter) 3-4 days after stimulation, and 3 months after enrollment
Secondary Strength of hands (MRC) 3-4 days after stimulation, and 3 months after enrollment
Secondary National Institute of Health Stroke Scale (NIHSS) enrollment
Secondary modified Ranking Scale (mRS) 3-4 days after stimulation, and 3 months after enrollment
Secondary Aphasia Check List (ACL-K) 3-4 days after stimulation, and 3 months after enrollment

Sponsors