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StrokeNETSNCT00909714

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

A study testing DC-Stimulator to apply tDCS in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
DC-Stimulator to apply tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
119 participants
Where
11 sitesin 3 countries
Study dates
Jul 2009to 31 Mar 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

Germany9 sites

  • Neurologische Klinik Bad Aibling

    Bad Aibling, 83043

  • Neurologie Moritzklinik

    Bad Klosterlausnitz, Thuringia, 07639

  • Neurologisches Zentrum Segeberger Kliniken

    Bad Segeberg, 23795

  • NRZ Leipzig

    Bennewitz, 04828

  • MEDIAN Klinik Berlin-Kladow

    Berlin, 14089

  • Brandenburgklinik Berlin-Brandenburg

    Bernau Bei Berlin, State of Berlin, 16321

  • University Medical Center Hamburg Eppendorf (UKE)

    Hamburg, 20246

  • University Medical Center Heidelberg

    Heidelberg, 69120

  • Klinik Kipfenberg

    Kipfenberg, Bavaria, 85110

Other trials in Germany

Austria1 site

  • Neurologische Universitätsklinik Wien

    Vienna, State of Vienna, 1090

Other trials in Austria

Italy1 site

  • Fondazione Santa Lucia

    Rome, 00179

Other trials in Italy

About this study

Official title: Neuroregeneration Enhanced by TDCS in Stroke

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.

Read the detailed description

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
Stroke
Being tested
DC-Stimulator to apply tDCS, DC-Stimulator to apply Sham tDCS
Keywords
stroke, non-invasive cortical stimulation, motor recovery, cortical plasticity, TDCS
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC-Stimulator to apply tDCSDevice

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

  • DC-Stimulator to apply Sham tDCSDevice

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

Study groups in NCT00909714
Study groupRoleWhat they receive
Anodal tDCSExperimentalDirect Current (DC)-Stimulator to apply tDCS + Training
Receives: Device: DC-Stimulator to apply tDCS
Sham tDCSSham comparatorDirect Current (DC)-Stimulator to apply Sham tDCS (Placebo) + Training
Receives: Device: DC-Stimulator to apply Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Upper Extremity Fugl-Meyer-Assessment (UEFMA)

    standardized test of upper extremity function

    Measured: 1-7 days after the end of the intervention

Secondary outcomes (23)

  1. Upper Extremity Fugl-Meyer-Assessment (UEFMA)

    standardized test of upper extremity function

    Measured: 30±10 days after the intervention

  2. Upper Extremity Fugl-Meyer-Assessment (UEFMA)

    standardized test of upper extremity function

    Measured: 90±20 days after the intervention

  3. Upper Extremity Fugl-Meyer-Assessment (UEFMA) | Long-term outcome

    standardized test of upper extremity function

    Measured: 12±1 months after the intervention

  4. Action Research Arm Test (ARAT)

    standardized tests of upper extremity function

    Measured: 1-7 days after the end of the intervention

  5. Action Research Arm Test (ARAT)

    standardized tests of upper extremity function

    Measured: 30±10 days after the intervention

  6. Action Research Arm Test (ARAT)

    standardized tests of upper extremity function

    Measured: 90±20 days after the intervention

  7. Action Research Arm Test (ARAT) | Long-term outcome

    standardized tests of upper extremity function

    Measured: 12±1 months after the intervention

  8. Nine Hole Peg Test (NHPT)

    standardized test to assess fine motor skills

    Measured: 1-7 days after the end of the intervention

  9. Nine Hole Peg Test (NHPT)

    standardized test to assess fine motor skills

    Measured: 30±10 days after the intervention

  10. Nine Hole Peg Test (NHPT)

    standardized test to assess fine motor skills

    Measured: 90±20 days after the intervention

  11. Nine Hole Peg Test (NHPT) | Long-term outcome

    standardized test to assess fine motor skills

    Measured: 12±1 months after the intervention

  12. Stroke Impact Scale (SIS)

    questionnaire is to evaluate how stroke has impacted health and life of patients

    Measured: 1-7 days after the end of the intervention

  13. Stroke Impact Scale (SIS)

    questionnaire is to evaluate how stroke has impacted health and life of patients

    Measured: 30±10 days after the intervention

  14. Stroke Impact Scale (SIS)

    questionnaire is to evaluate how stroke has impacted health and life of patients

    Measured: 90±20 days after the intervention

  15. Stroke Impact Scale (SIS) | Long-term outcome

    questionnaire is to evaluate how stroke has impacted health and life of patients

    Measured: 12±1 months after the intervention

  16. Box-and-Block Test

    standardized test to assess fine motor skills

    Measured: 1-7 days after the end of the intervention

  17. Box-and-Block Test

    standardized test to assess fine motor skills

    Measured: 30±10 days after the intervention

  18. Box-and-Block Test

    standardized test to assess fine motor skills

    Measured: 90±20 days after the intervention

  19. Box-and-Block Test

    standardized test to assess fine motor skills

    Measured: 12±1 months after the intervention

  20. Grip Force

    dynamometer-based test to assess grip strength

    Measured: 1-7 days after the end of the intervention

  21. Grip Force

    dynamometer-based test to assess grip strength

    Measured: 30±10 days after the intervention

  22. Grip Force

    dynamometer-based test to assess grip strength

    Measured: 90±20 days after the intervention

  23. Grip Force

    dynamometer-based test to assess grip strength

    Measured: 12±1 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2009 (estimated)
  2. Study startJul 2009
  3. Primary completion19 Feb 2021
  4. Study completion31 Mar 2021

Resources

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
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00909714
Sponsor's protocol ID
NETS Trial
Acronym
NETS
Status last verified
Dec 2024
First submitted
12 May 2009
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Data sharing is planned after main publication of results.

Publications

  • 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.

    PubMed 35430801

  • 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.

    PubMed 38476746

  • 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.

    PubMed 33175411

Questions about this trial

What is this clinical trial studying?

A study testing DC-Stimulator to apply tDCS in people with Stroke, run by Universitätsklinikum Hamburg-Eppendorf at 11 sites in 3 countries.

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 1 inclusion and 13 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 11 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 11 sites in Germany, Austria, Italy. 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?

Upper Extremity Fugl-Meyer-Assessment (UEFMA) (time frame: 1-7 days after the end of the intervention). 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 NCT00909714, 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 11 Dec 2024.

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