StrokeRAdiCSNCT03185234
Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation
A study testing anodal tDCS in people with Stroke and Apraxia, run by University of Cologne at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- anodal tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 2 sitesGermany
- Study dates
- 23 Jun 2017to 9 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Rehabilitationszentrum Godeshöhe e.V.
Bonn, North Rhine-Westphalia, 53177
MediClin Fachklinik Rhein/Ruhr für Neurologie
Essen, North Rhine-Westphalia, 45219
About this study
Official title: 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.
Read the 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.
- Being tested
- anodal tDCS, sham tDCS
- Keywords
- tDCS
- Medical subject headings
- Stroke, Apraxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anodal tDCSDevice
Also called neuroConn DCS, model no. 008
2 mA, 10 min, 5 sessions
sham tDCSDevice
Also called neuroConn DCS, model no. 008
sham stimulation, 10 min, 5 sessions
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Active comparator | 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. Receives: Device: anodal tDCS |
| Sham tDCS | Sham comparator | 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. Receives: Device: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
KAS (Cologne Apraxia Screening)
Degree of apraxia
Measured: 3-4 days after stimulation
Secondary outcomes (11)
KAS (Cologne Apraxia Screening)
Degree of apraxia
Measured: 3 months after enrollment
Goldenberg Imitation
Degree of apraxia
Measured: 3-4 days after stimulation, and 3 months after enrollment
de Renzi Imitation
Degree of apraxia
Measured: 3-4 days after stimulation, and 3 months after enrollment
de Renzi actual tool use
Degree of apraxia
Measured: 3-4 days after stimulation, and 3 months after enrollment
Action Research Arm Test (ARAT)
Motor function
Measured: 3-4 days after stimulation, and 3 months after enrollment
Jebsen Taylor Hand Function Test (JTHFT)
Motor function
Measured: 3-4 days after stimulation, and 3 months after enrollment
Gripforce (Vigorimeter)
Motor function
Measured: 3-4 days after stimulation, and 3 months after enrollment
Strength of hands (MRC)
Motor function
Measured: 3-4 days after stimulation, and 3 months after enrollment
National Institute of Health Stroke Scale (NIHSS)
Impairment by stroke
Measured: enrollment
modified Ranking Scale (mRS)
Impairment by stroke
Measured: 3-4 days after stimulation, and 3 months after enrollment
Aphasia Check List (ACL-K)
Aphasia
Measured: 3-4 days after stimulation, and 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start23 Jun 2017
- Primary completion13 Jul 2021
- Study completion9 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gereon R. Fink, University of Cologne
- Investigators
- Gereon R. Fink, Univ-Prof., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03185234
- Sponsor's protocol ID
- Uni-Koeln-3033
- Other IDs
- U1111-1195-2536, DRKS00012292
- Acronym
- RAdiCS
- Status last verified
- May 2022
- First submitted
- 31 May 2017
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33324913
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutischer Einsatz Der Schwachen Gleichstromstimulation (tDCS) Bei Motorisch-kognitiven Defiziten Nach Schlaganfall
- ClinicalTrials.gov ID
- NCT03185234
- Acronym / sponsor ID
- RAdiCS / Uni-Koeln-3033
- Keywords
- tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 9 Nov 2021 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Active comparator | Device: anodal tDCSAnodal 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 | Sham comparator | Device: sham tDCSSham 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anodal tDCSAlso: neuroConn DCS, model no. 0082 mA, 10 min, 5 sessions | Device | Real tDCS |
| sham tDCSAlso: neuroConn DCS, model no. 008sham stimulation, 10 min, 5 sessions | Device | Sham tDCS |
Primary outcome
KAS (Cologne Apraxia Screening)
Time frame: 3-4 days after stimulation
Degree of apraxia
11 secondary outcomes
KAS (Cologne Apraxia Screening)
Time frame: 3 months after enrollment
Goldenberg Imitation
Time frame: 3-4 days after stimulation, and 3 months after enrollment
de Renzi Imitation
Time frame: 3-4 days after stimulation, and 3 months after enrollment
de Renzi actual tool use
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Action Research Arm Test (ARAT)
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Jebsen Taylor Hand Function Test (JTHFT)
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Gripforce (Vigorimeter)
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Strength of hands (MRC)
Time frame: 3-4 days after stimulation, and 3 months after enrollment
National Institute of Health Stroke Scale (NIHSS)
Time frame: enrollment
modified Ranking Scale (mRS)
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Aphasia Check List (ACL-K)
Time frame: 3-4 days after stimulation, and 3 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2022.
- Derived from this study: PubMed 33324913Kleineberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gereon R. Fink, Univ-Prof. principal investigator
University Hospital of Cologne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anodal tDCS in people with Stroke and Apraxia, run by University of Cologne at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KAS (Cologne Apraxia Screening) (time frame: 3-4 days after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03185234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2022.