Stroke, IschemicMARK-NIBSNCT05560724
Network Properties As Biomarkers for Non-Invasive Brain Stimulation (NIBS) After Stroke
A study testing Transcranial direct current stimulation (tDCS) in people with Stroke, Ischemic, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The present study will evaluate the potential of cortico-cerebellar network properties derived from neuroimaging in a group of chronic stroke patients to explain inter-subject variability in responsiveness to transcranial direct current stimulation (tDCS) targeting the cortico-spinal and cortico-cerebellar network. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic
- What is being tested?
- Transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2022to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients after first-ever clinical ischemic stroke in the early (>3 month) or later chronic (>6 months) stage of recovery
- persistent motor deficit of the upper extremity
- stroke location: supratentorial
- age > 18 years
- written informed consent obtained
Who cannot join
- contraindication against MRI \& tDCS
- known epilepsy, previous epileptic seizure
- electric implants such as brain stimulator
- medical history suggesting more than one previous stroke
- severe polyneuropathy and peripheral ischemic vascular diseases; only if they critically influence sensorimotor function of the upper limb
- any active drug and alcohol abuse
Show all 9Show fewer
- any active and severe psychiatric disease (such as psychosis)
- severe cognitive deficits (mini mental state examination, MMSE ≤ 23)
- uncontrolled other medical problems (cardiovascular diseases, instable arrhythmia, arthritis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf, Dept. of Neurology
Hamburg, Free and Hanseatic City of Hamburg, 20246
Robert Schulz, PD Dr. med.
About this study
Official title: Evaluation of Cortico-Cerebellar Network Properties As Biomarkers for the Responsiveness to Cortico-Cerebellar Brain Stimulation in Stroke Patients
The present study will evaluate the potential of cortico-cerebellar network properties derived from neuroimaging in a group of chronic stroke patients to explain inter-subject variability in responsiveness to transcranial direct current stimulation (tDCS) targeting the cortico-spinal and cortico-cerebellar network.
Read the detailed description
Various studies have aimed to explore the potential of non-invasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) to promote motor recovery after stroke. After promising results from early proof-of-concept studies, particularly for the stimulation of the primary motor cortex (M1), it has become evident that the translation from scientific to clinical application is challenging. Aiming to uncover alternative stimulation targets, the cortico-cerebellar network and cerebellar brain stimulation have gained an increasing interest in the field of neurorehabilitation. However, large inter-study and inter-subject variability in behavioural responses to tDCS indicated that a one-size-fits-all approach might not lead to sufficient effect sizes in clinical populations. As structural and functional brain imaging has significantly evolved to powerful tools to assess distinct neuronal networks, such as the cortico-cerebellar network, in individual stroke patients and to infer structure-function-behaviour-relationships, the question arises whether such information might serve as imaging biomarkers to inform about the treatment responsiveness to non-invasive brain stimulation.
The present study will evaluate the potential of cortico-cerebellar network properties in a group of chronic stroke patients and healthy participants to explain inter-subject variability in responsiveness to two brain stimulation approaches targeting the cortico-spinal and cortico-cerebellar network: 1) cortical M1 tDCS, 2) combined M1 and cerebellar tDCS. Participants will be examined clinically and by structural and functional MRI. Structural MRI will be used to primarily reconstruct cortico-spinal and cortico-cerebellar motor tracts. Tract-related diffusion-based parameters will be used to infer microstructural network integrity. Resting-state MRI will be acquired to assess functional network connectivity. The behavioural impact of the tDCS will be evaluated during a multi-session structured motor training paradigm over seven days.
Recruitment:
Early- or late chronic stroke patients who have a persistent upper extremity deficit.
Treatment/Intervention:
Three tDCS montages combined with 7 days of physiotherapy (45min per session) will be applied to chronic stroke patients in a double-blinded, parallel group design. The following montages will be tested: anodal ipsilesional M1-stimulation with 2mA, anodal ipsilesion M1-stimulation combined with anodal contralesional cerebellar stimulation with 2mA per anode and a sham stimulation. The stimulation will be applied for the first 20min of physiotherapy.
Evaluation/Measurement:
Prior to the intervention, patients will receive functional testing and a MRI scan. 7 days after physiotherapy, functional testing will be performed again. Functional tests include: NIH Stroke Scale (NIHSS), Fugl Meyer Assessment of the upper limb (FMA), Wolf Motor Function Test (WMFT), Jebsen Taylor Hand Function Test (JTT), Nine-Hole-Peg-Test (NHP), Mini-Mental-State Examination.
Analyses:
Statistics will be conducted to relate neuroimaging-based network properties of the cortico-spinal and cortico-cerebellar network to the treatment gains under tDCS combined with motor training (primary outcome). Importantly, group differences regarding the behavioural effects of the verum and sham condition will serve as secondary outcomes.
- Conditions
- Stroke, Ischemic
- Being tested
- Transcranial direct current stimulation (tDCS)
- Keywords
- brain stimulation, biomarker, tDCS, NIBS, recovery, M1, primary motor, cerebellum
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS)Device
Anodal stimulation or sham
| Study group | Role | What they receive |
|---|---|---|
| Anodal M1 tDCS | Active comparator | 20 minutes of anodal tDCS (C3 or C4 depending on side of lesion) to the ipsilesional M1: 2mA Combined with 45min of structured motor training. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Combined M1 and cerebellar anodal tDCS | Active comparator | 20 minutes of anodal tDCS (C3 or C4 depending on side of lesion) to the ipsilesional M1 combined with contralesional cerebellar montage (2cm lateral to Inion): 2mA per anode Combined with 45min of structured motor training. Receives: Device: Transcranial direct current stimulation (tDCS) |
| Sham tDCS | Sham comparator | Sham stimulation. Combined with 45min of structured motor training. Receives: Device: Transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until last training day (Day 7)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the FMA during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the FMA during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NIHSS from baseline in the verum and sham conditions until last training day (Day 7)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NIHSS during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NIHSS from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NIHSS during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in WMFT from baseline in the verum and sham conditions until last training day (Day 7)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in WMFT during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in WMFT from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in WMFT during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in JTT from baseline in the verum and sham conditions until last training day (Day 7)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in JTT during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in JTT from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in JTT during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NHP from baseline in the verum and sham conditions until last training day (Day 7)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NHP during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NHP from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NHP during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Secondary outcomes (10)
Treatment effects for NIHSS on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Statistics will be conducted to compare treament effects in NIHSS between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Treatment effects for FMA on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Statistics will be conducted to compare treament effects in FMA between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Treatment effects for JTT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Statistics will be conducted to compare treament effects in JTT between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Treatment effects for WMFT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Statistics will be conducted to compare treament effects in WMFT between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Treatment effects for NHP on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Statistics will be conducted to compare treament effects in NHP between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 7
Treatment effects for NIHSS on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Statistics will be conducted to compare treament effects in NIHSS between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Treatment effects for FMA on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Statistics will be conducted to compare treament effects in FMA between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Treatment effects for WMFT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Statistics will be conducted to compare treament effects in WMFT between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Treatment effects for JTT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Statistics will be conducted to compare treament effects in JTT between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Treatment effects for NHP on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Statistics will be conducted to compare treament effects in NHP between groups during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Measured: Baseline - Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Jul 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind parallel group design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Robert Schulz, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Robert Schulz, PD Dr. med., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560724
- Sponsor's protocol ID
- MARK-NIBS
- Acronym
- MARK-NIBS
- Status last verified
- Dec 2024
- First submitted
- 21 Sep 2022
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schulz R, Gerloff C, Hummel FC. Non-invasive brain stimulation in neurological diseases. Neuropharmacology. 2013 Jan;64:579-87. doi: 10.1016/j.neuropharm.2012.05.016. Epub 2012 Jun 9.
PubMed 22687520Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
PubMed 15634731Kang N, Summers JJ, Cauraugh JH. Transcranial direct current stimulation facilitates motor learning post-stroke: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2016 Apr;87(4):345-55. doi: 10.1136/jnnp-2015-311242. Epub 2015 Aug 28.
PubMed 26319437
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cortico-Cerebellar Network Properties As Biomarkers for the Responsiveness to Cortico-Cerebellar Brain Stimulation in Stroke Patients
- ClinicalTrials.gov ID
- NCT05560724
- Acronym / sponsor ID
- MARK-NIBS / MARK-NIBS
- Conditions
- Stroke, Ischemic
- Keywords
- brain stimulation, biomarker, tDCS, NIBS, recovery, M1, primary motor, cerebellum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Sep 2022 (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 present study will evaluate the potential of cortico-cerebellar network properties derived from neuroimaging in a group of chronic stroke patients to explain inter-subject variability in responsiveness to transcranial direct current stimulation (tDCS) targeting the cortico-spinal and cortico-cerebellar network.
Detailed description
Various studies have aimed to explore the potential of non-invasive brain stimulation techniques such as transcranial direct current stimulation (tDCS) to promote motor recovery after stroke. After promising results from early proof-of-concept studies, particularly for the stimulation of the primary motor cortex (M1), it has become evident that the translation from scientific to clinical application is challenging. Aiming to uncover alternative stimulation targets, the cortico-cerebellar network and cerebellar brain stimulation have gained an increasing interest in the field of neurorehabilitation. However, large inter-study and inter-subject variability in behavioural responses to tDCS indicated that a one-size-fits-all approach might not lead to sufficient effect sizes in clinical populations. As structural and functional brain imaging has significantly evolved to powerful tools to assess distinct neuronal networks, such as the cortico-cerebellar network, in individual stroke patients and to infer structure-function-behaviour-relationships, the question arises whether such information might serve as imaging biomarkers to inform about the treatment responsiveness to non-invasive brain stimulation.
The present study will evaluate the potential of cortico-cerebellar network properties in a group of chronic stroke patients and healthy participants to explain inter-subject variability in responsiveness to two brain stimulation approaches targeting the cortico-spinal and cortico-cerebellar network: 1) cortical M1 tDCS, 2) combined M1 and cerebellar tDCS. Participants will be examined clinically and by structural and functional MRI. Structural MRI will be used to primarily reconstruct cortico-spinal and cortico-cerebellar motor tracts. Tract-related diffusion-based parameters will be used to infer microstructural network integrity. Resting-state MRI will be acquired to assess functional network connectivity. The behavioural impact of the tDCS will be evaluated during a multi-session structured motor training paradigm over seven days.
Recruitment:
Early- or late chronic stroke patients who have a persistent upper extremity deficit.
Treatment/Intervention:
Three tDCS montages combined with 7 days of physiotherapy (45min per session) will be applied to chronic stroke patients in a double-blinded, parallel group design. The following montages will be tested: anodal ipsilesional M1-stimulation with 2mA, anodal ipsilesion M1-stimulation combined with anodal contralesional cerebellar stimulation with 2mA per anode and a sham stimulation. The stimulation will be applied for the first 20min of physiotherapy.
Evaluation/Measurement:
Prior to the intervention, patients will receive functional testing and a MRI scan. 7 days after physiotherapy, functional testing will be performed again. Functional tests include: NIH Stroke Scale (NIHSS), Fugl Meyer Assessment of the upper limb (FMA), Wolf Motor Function Test (WMFT), Jebsen Taylor Hand Function Test (JTT), Nine-Hole-Peg-Test (NHP), Mini-Mental-State Examination.
Analyses:
Statistics will be conducted to relate neuroimaging-based network properties of the cortico-spinal and cortico-cerebellar network to the treatment gains under tDCS combined with motor training (primary outcome). Importantly, group differences regarding the behavioural effects of the verum and sham condition will serve as secondary outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Double-blind parallel group design.
| Arm | Type | Receives |
|---|---|---|
| Anodal M1 tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)20 minutes of anodal tDCS (C3 or C4 depending on side of lesion) to the ipsilesional M1: 2mA Combined with 45min of structured motor training. |
| Combined M1 and cerebellar anodal tDCS | Active comparator | Device: Transcranial direct current stimulation (tDCS)20 minutes of anodal tDCS (C3 or C4 depending on side of lesion) to the ipsilesional M1 combined with contralesional cerebellar montage (2cm lateral to Inion): 2mA per anode Combined with 45min of structured motor training. |
| Sham tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS)Sham stimulation. Combined with 45min of structured motor training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients after first-ever clinical ischemic stroke in the early (>3 month) or later chronic (>6 months) stage of recovery
- persistent motor deficit of the upper extremity
- stroke location: supratentorial
- age > 18 years
- written informed consent obtained
Key exclusion criteria (9 listed)
- contraindication against MRI \& tDCS
- known epilepsy, previous epileptic seizure
- electric implants such as brain stimulator
- medical history suggesting more than one previous stroke
- severe polyneuropathy and peripheral ischemic vascular diseases; only if they critically influence sensorimotor function of the upper limb
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 |
|---|---|---|
| Transcranial direct current stimulation (tDCS)Anodal stimulation or sham | Device | Anodal M1 tDCS, Combined M1 and cerebellar anodal tDCS, Sham tDCS |
Primary outcome
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until last training day (Day 7)
Time frame: Baseline - Day 7
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the FMA during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Time frame: Baseline - Day 14
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the FMA during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NIHSS from baseline in the verum and sham conditions until last training day (Day 7)
Time frame: Baseline - Day 7
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NIHSS during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NIHSS from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Time frame: Baseline - Day 14
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NIHSS during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in WMFT from baseline in the verum and sham conditions until last training day (Day 7)
Time frame: Baseline - Day 7
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in WMFT during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in WMFT from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Time frame: Baseline - Day 14
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in WMFT during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in JTT from baseline in the verum and sham conditions until last training day (Day 7)
Time frame: Baseline - Day 7
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in JTT during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in JTT from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Time frame: Baseline - Day 14
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in JTT during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NHP from baseline in the verum and sham conditions until last training day (Day 7)
Time frame: Baseline - Day 7
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NHP during active and sham stimulations. Treatment gains will be defined as change from baseline until last training day (Day 7). Statistics will be adjusted for baseline values.
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in NHP from baseline in the verum and sham conditions until 1 week after last training day (Day 14)
Time frame: Baseline - Day 14
Statistics will be conducted to relate single-patient data of structural and functional network properties to treatment gains in the NHP during active and sham stimulations. Treatment gains will be defined as change from baseline until 1 week after last training day (Day 14). Statistics will be adjusted for baseline values.
10 secondary outcomes
Treatment effects for NIHSS on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Time frame: Baseline - Day 7
Treatment effects for FMA on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Time frame: Baseline - Day 7
Treatment effects for JTT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Time frame: Baseline - Day 7
Treatment effects for WMFT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Time frame: Baseline - Day 7
Treatment effects for NHP on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and last training day (Day 7).
Time frame: Baseline - Day 7
Treatment effects for NIHSS on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Time frame: Baseline - Day 14
Treatment effects for FMA on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Time frame: Baseline - Day 14
Treatment effects for WMFT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Time frame: Baseline - Day 14
Treatment effects for JTT on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Time frame: Baseline - Day 14
Treatment effects for NHP on group level comparing M1 tDCS, M1-cerebellar tDCS and sham between baseline and 1 week after last training day (Day 14).
Time frame: Baseline - Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Background: PubMed 22687520Schulz R, Gerloff C, Hummel FC. Non-invasive brain stimulation in neurological diseases. Neuropharmacology. 2013 Jan;64:579-87. doi: 10.1016/j.neuropharm.2012.05.016. Epub 2012 Jun 9.
- Background: PubMed 15634731Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. doi: 10.1093/brain/awh369. Epub 2005 Jan 5.
- Background: PubMed 26319437Kang N, Summers JJ, Cauraugh JH. Transcranial direct current stimulation facilitates motor learning post-stroke: a systematic review and meta-analysis. J Neurol Neurosurg Psychiatry. 2016 Apr;87(4):345-55. doi: 10.1136/jnnp-2015-311242. Epub 2015 Aug 28.
- 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.
Robert Schulz, PD Dr. med. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation (tDCS) in people with Stroke, Ischemic, run by Universitätsklinikum Hamburg-Eppendorf at 1 site 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 17 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert Schulz, PD Dr. med. (0049-40-7410-0, rschulz@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between properties of the cortico-spinal and cortico-cerebellar motor network and change in FMA from baseline in the verum and sham conditions until last training day (Day 7) (time frame: Baseline - Day 7). The study lists 10 primary outcomes in all. 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 NCT05560724, which also lists 3 linked publications.
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 17 Dec 2024.