Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

Stroke Clinical Trial

— RAdiCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185234
• Other study ID #: Uni-Koeln-3033
• Secondary ID: U1111-1195-2536D
• Status: Completed
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: November 9, 2021

Study information

• Verified date: May 2022
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 9, 2021
• Est. primary completion date: July 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Apraxia
• Apraxias
• Stroke

Intervention

Device:
• anodal tDCS
2 mA, 10 min, 5 sessions
• sham tDCS
sham stimulation, 10 min, 5 sessions

Locations

Country	Name	City	State
Germany	Rehabilitationszentrum Godeshöhe e.V.	Bonn	NRW
Germany	MediClin Fachklinik Rhein/Ruhr für Neurologie	Essen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

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