NCT03185234

Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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

• Stroke
• Apraxia

Interventions

Type	Name	Description
DEVICE	anodal tDCS	2 mA, 10 min, 5 sessions
DEVICE	sham tDCS	sham stimulation, 10 min, 5 sessions

Timeline

• Start date: 2017-06-23
• Primary completion: 2021-07-13
• Completion: 2021-11-09
• First posted: 2017-06-14
• Last updated: 2022-05-20

Locations

2 sites across 1 country: Germany