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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Apraxia
• Intervention / Treatment: Device: anodal tDCS; Device: sham tDCS

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53177
      • Rehabilitationszentrum Godeshöhe e.V.
    • Essen, NRW, Germany, 45219
      • MediClin Fachklinik Rhein/Ruhr für Neurologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: neuroConn DCS, model no. 008

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KAS (Cologne Apraxia Screening)	Degree of apraxia	3-4 days after stimulation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Principal Investigator: Gereon R. Fink, Univ-Prof., University Hospital Cologne

Publications and helpful links

General Publications

• Kleineberg NN, Richter MK, Becker I, Weiss PH, Fink GR. Verum versus sham tDCS in the treatment of stroke-induced apraxia: study protocol of the randomized controlled trial RAdiCS -"Rehabilitating (stroke-induced) Apraxia with direct Current Stimulation". Neurol Res Pract. 2020 Mar 4;2:7. doi: 10.1186/s42466-020-0052-y. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2017
• Primary Completion (Actual): July 13, 2021
• Study Completion (Actual): November 9, 2021

Study Registration Dates

• First Submitted: May 31, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: tDCS
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Psychomotor Disorders; Apraxias
• Other Study ID Numbers: Uni-Koeln-3033; U1111-1195-2536 (Other Identifier: WHO); DRKS00012292 (Registry Identifier: DRKS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No