MedDataX Logo

Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke

NCT ID: NCT00909714

Last Updated: 2024-12-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2021-03-31

Brief Summary

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

Testing the hypothesis that non-invasive brain stimulation by transcranial direct current stimulation (tDCS) combined with functional training in the subacute phase of first-ever stroke will enhance functional regeneration compared with a Placebo intervention.

Detailed Description

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

Stroke is the leading cause of long-term disability, which significantly impairs the economic and social life of patients and society. Every year 200 000 to 250 000 patients suffer a stroke in Germany. Only a small number of the stroke survivors recover to a degree that allows them to return into their professional and private life. Despite significant efforts to develop novel and efficient treatment strategies the level of functional regeneration is still not satisfying. Thus, the development of innovative and effective treatment strategies will have a major impact for the patients' life, the society and the public health system.

Within the proposed project an innovative, non-invasive and cost effective interventional strategy, based on the combination of a specific rehabilitative training and brain stimulation by transcranial direct current stimulation (tDCS), will be used to enhance functional regeneration in stroke patients. The intervention will be applied in an early stage in which plasticity, cortical reorganization and functional improvement is most pronounced. We hypothesize that the combination of anodal tDCS delivered to the motor cortex of the affected hemisphere combined with training over a period of two weeks in the subacute stage after stroke will significantly enhance cortical plasticity, functional regeneration and long-term outcome determined by clinical and functional outcome measures compared with Placebo stimulation.

Conditions

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

Stroke

Keywords

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

stroke non-invasive cortical stimulation motor recovery cortical plasticity TDCS

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Anodal tDCS

Direct Current (DC)-Stimulator to apply tDCS + Training

Group Type EXPERIMENTAL

DC-Stimulator to apply tDCS

Intervention Type DEVICE

Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Sham tDCS

Direct Current (DC)-Stimulator to apply Sham tDCS (Placebo) + Training

Group Type SHAM_COMPARATOR

DC-Stimulator to apply Sham tDCS

Intervention Type DEVICE

Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Interventions

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

DC-Stimulator to apply tDCS

Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Intervention Type DEVICE

DC-Stimulator to apply Sham tDCS

Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* Subacute stroke patients (5-45 days after stroke) with thromboembolic non-hemorrhagic subcortical or cortical, first clinically overt stroke will be included. Moderate to moderately severe upper-extremity hemiparesis, defined as an Upper Extremity Fugl-Meyer score (UEFMA) between 20 and 58 (inclusive).

Exclusion Criteria

* pre-existing large lesions (\> 1.5 cm maximum diameter) in a brain area that belongs to the anatomically established sensorimotor/premotor system
* progressive stroke
* completely lesioned hand knob area of M1 affected if no motor evoked potentials (MEPs) elicited by transcranial magnetic stimulation (TMS) are present
* bilateral motor impairment
* florid alcohol and/or drug abuse
* florid severe psychiatric illness (e.g. schizophrenia)
* severe language disturbances that prevents the patient to give informed consent or inhibit adequate scoring because of insufficient understanding of scoring introductions
* tumor diseases with a life expectancy less than one year
* increased intracranial pressure
* polyneuropathy and/or ischemic peripheral disease if the sensorimotor functions of the upper extremities are affected clinically relevant
* severe cognitive deficits (MMSE ≤ 23)
* pregnancy
* contraindication for MRI or TMS
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.

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.

Responsibility Role SPONSOR

Principal Investigators

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

Christian Gerloff, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Medical Center Hamburg-Eppendorf

Locations

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

Neurologische Universitätsklinik Wien

Vienna, Vienna, Austria

Site Status

Klinik Kipfenberg

Kipfenberg, Bavaria, Germany

Site Status

Brandenburgklinik Berlin-Brandenburg

Bernau Bei Berlin, State of Berlin, Germany

Site Status

Neurologie Moritzklinik

Bad Klosterlausnitz, Thuringia, Germany

Site Status

Neurologische Klinik Bad Aibling

Bad Aibling, , Germany

Site Status

Neurologisches Zentrum Segeberger Kliniken

Bad Segeberg, , Germany

Site Status

NRZ Leipzig

Bennewitz, , Germany

Site Status

MEDIAN Klinik Berlin-Kladow

Berlin, , Germany

Site Status

University Medical Center Hamburg Eppendorf (UKE)

Hamburg, , Germany

Site Status

University Medical Center Heidelberg

Heidelberg, , Germany

Site Status

Fondazione Santa Lucia

Rome, , Italy

Site Status

Countries

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

France Switzerland Austria Germany Italy

References

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

NETS Trial Collaboration Group. A multicenter, randomized, double-blind, placebo-controlled trial to test efficacy and safety of transcranial direct current stimulation to the motor cortex after stroke (NETS): study protocol. Neurol Res Pract. 2022 Apr 18;4(1):14. doi: 10.1186/s42466-022-00171-2.

Reference Type BACKGROUND
PMID: 35430801 (View on PubMed)

NETS Trial Collaboration Group. Efficacy and safety of transcranial direct current stimulation to the ipsilesional motor cortex in subacute stroke (NETS): a multicenter, randomized, double-blind, placebo-controlled trial. Lancet Reg Health Eur. 2024 Jan 2;38:100825. doi: 10.1016/j.lanepe.2023.100825. eCollection 2024 Mar.

Reference Type BACKGROUND
PMID: 38476746 (View on PubMed)

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Reference Type DERIVED
PMID: 33175411 (View on PubMed)

Other Identifiers

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

NETS Trial

Identifier Type: -

Identifier Source: org_study_id