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

Primary Purpose

Stroke, Apraxia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
anodal tDCS
sham tDCS
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitationszentrum Godeshöhe e.V.
  • MediClin Fachklinik Rhein/Ruhr für Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Real tDCS

Sham tDCS

Arm 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 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

Primary Outcome Measures

KAS (Cologne Apraxia Screening)
Degree of apraxia

Secondary Outcome Measures

KAS (Cologne Apraxia Screening)
Degree of apraxia
Goldenberg Imitation
Degree of apraxia
de Renzi Imitation
Degree of apraxia
de Renzi actual tool use
Degree of apraxia
Action Research Arm Test (ARAT)
Motor function
Jebsen Taylor Hand Function Test (JTHFT)
Motor function
Gripforce (Vigorimeter)
Motor function
Strength of hands (MRC)
Motor function
National Institute of Health Stroke Scale (NIHSS)
Impairment by stroke
modified Ranking Scale (mRS)
Impairment by stroke
Aphasia Check List (ACL-K)
Aphasia

Full Information

First Posted
May 31, 2017
Last Updated
May 19, 2022
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT03185234
Brief Title
Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation
Acronym
RAdiCS
Official Title
Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
July 13, 2021 (Actual)
Study Completion Date
November 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Apraxia
Keywords
tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real tDCS
Arm Type
Active Comparator
Arm 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.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
anodal tDCS
Other Intervention Name(s)
neuroConn DCS, model no. 008
Intervention Description
2 mA, 10 min, 5 sessions
Intervention Type
Device
Intervention Name(s)
sham tDCS
Other Intervention Name(s)
neuroConn DCS, model no. 008
Intervention Description
sham stimulation, 10 min, 5 sessions
Primary Outcome Measure Information:
Title
KAS (Cologne Apraxia Screening)
Description
Degree of apraxia
Time Frame
3-4 days after stimulation
Secondary Outcome Measure Information:
Title
KAS (Cologne Apraxia Screening)
Description
Degree of apraxia
Time Frame
3 months after enrollment
Title
Goldenberg Imitation
Description
Degree of apraxia
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
de Renzi Imitation
Description
Degree of apraxia
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
de Renzi actual tool use
Description
Degree of apraxia
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
Action Research Arm Test (ARAT)
Description
Motor function
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
Jebsen Taylor Hand Function Test (JTHFT)
Description
Motor function
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
Gripforce (Vigorimeter)
Description
Motor function
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
Strength of hands (MRC)
Description
Motor function
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
National Institute of Health Stroke Scale (NIHSS)
Description
Impairment by stroke
Time Frame
enrollment
Title
modified Ranking Scale (mRS)
Description
Impairment by stroke
Time Frame
3-4 days after stimulation, and 3 months after enrollment
Title
Aphasia Check List (ACL-K)
Description
Aphasia
Time Frame
3-4 days after stimulation, and 3 months after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gereon R. Fink, Univ-Prof.
Organizational Affiliation
University Hospital Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitationszentrum Godeshöhe e.V.
City
Bonn
State/Province
NRW
ZIP/Postal Code
53177
Country
Germany
Facility Name
MediClin Fachklinik Rhein/Ruhr für Neurologie
City
Essen
State/Province
NRW
ZIP/Postal Code
45219
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33324913
Citation
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.
Results Reference
derived

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Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

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