MedDataX Logo

Network Properties As Biomarkers for Non-Invasive Brain Stimulation (NIBS) After Stroke

NCT ID: NCT05560724

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2026-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Ischemic

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

brain stimulation biomarker tDCS NIBS recovery M1 primary motor cerebellum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind parallel group design.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anodal M1 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.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Anodal stimulation or sham

Combined M1 and cerebellar anodal 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.

Group Type ACTIVE_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Anodal stimulation or sham

Sham tDCS

Sham stimulation. Combined with 45min of structured motor training.

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS)

Intervention Type DEVICE

Anodal stimulation or sham

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcranial direct current stimulation (tDCS)

Anodal stimulation or sham

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

German Research Foundation

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Robert Schulz

PD Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert Schulz, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Hamburg-Eppendorf, Dept. of Neurology

Hamburg, City state of Hamburg, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Robert Schulz, PD Dr. med.

Role: CONTACT

Phone: 0049-40-7410-0

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Robert Schulz, PD Dr. med.

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22687520 (View on PubMed)

Hummel 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.

Reference Type BACKGROUND
PMID: 15634731 (View on PubMed)

Kang 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.

Reference Type BACKGROUND
PMID: 26319437 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MARK-NIBS

Identifier Type: -

Identifier Source: org_study_id