Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909714
Recruitment Status : Active, not recruiting
First Posted : May 28, 2009
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Device: DC-Stimulator to apply tDCS Device: DC-Stimulator to apply Sham tDCS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroregeneration Enhanced by TDCS in Stroke
Study Start Date : July 2009
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: Anodal tDCS
Direct Current (DC)-Stimulator to apply tDCS + Training
Device: DC-Stimulator to apply tDCS
Anodal tDCS (20 minutes) stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

Sham Comparator: Sham tDCS
Direct Current (DC)-Stimulator to apply Sham tDCS (Placebo) + Training
Device: DC-Stimulator to apply Sham tDCS
Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training




Primary Outcome Measures :
  1. Upper Extremity Fugl-Meyer-Assessment (UEFMA) [ Time Frame: 1-7 days after the end of the intervention ]
    standardized test of upper extremity function


Secondary Outcome Measures :
  1. Upper Extremity Fugl-Meyer-Assessment (UEFMA) [ Time Frame: 30±10 days after the intervention ]
    standardized test of upper extremity function

  2. Upper Extremity Fugl-Meyer-Assessment (UEFMA) [ Time Frame: 90±20 days after the intervention ]
    standardized test of upper extremity function

  3. Upper Extremity Fugl-Meyer-Assessment (UEFMA) | Long-term outcome [ Time Frame: 12±1 months after the intervention ]
    standardized test of upper extremity function

  4. Action Research Arm Test (ARAT) [ Time Frame: 1-7 days after the end of the intervention ]
    standardized tests of upper extremity function

  5. Action Research Arm Test (ARAT) [ Time Frame: 30±10 days after the intervention ]
    standardized tests of upper extremity function

  6. Action Research Arm Test (ARAT) [ Time Frame: 90±20 days after the intervention ]
    standardized tests of upper extremity function

  7. Action Research Arm Test (ARAT) | Long-term outcome [ Time Frame: 12±1 months after the intervention ]
    standardized tests of upper extremity function

  8. Nine Hole Peg Test (NHPT) [ Time Frame: 1-7 days after the end of the intervention ]
    standardized test to assess fine motor skills

  9. Nine Hole Peg Test (NHPT) [ Time Frame: 30±10 days after the intervention ]
    standardized test to assess fine motor skills

  10. Nine Hole Peg Test (NHPT) [ Time Frame: 90±20 days after the intervention ]
    standardized test to assess fine motor skills

  11. Nine Hole Peg Test (NHPT) | Long-term outcome [ Time Frame: 12±1 months after the intervention ]
    standardized test to assess fine motor skills

  12. Stroke Impact Scale (SIS) [ Time Frame: 1-7 days after the end of the intervention ]
    questionnaire is to evaluate how stroke has impacted health and life of patients

  13. Stroke Impact Scale (SIS) [ Time Frame: 30±10 days after the intervention ]
    questionnaire is to evaluate how stroke has impacted health and life of patients

  14. Stroke Impact Scale (SIS) [ Time Frame: 90±20 days after the intervention ]
    questionnaire is to evaluate how stroke has impacted health and life of patients

  15. Stroke Impact Scale (SIS) | Long-term outcome [ Time Frame: 12±1 months after the intervention ]
    questionnaire is to evaluate how stroke has impacted health and life of patients

  16. Box-and-Block Test [ Time Frame: 1-7 days after the end of the intervention ]
    standardized test to assess fine motor skills

  17. Box-and-Block Test [ Time Frame: 30±10 days after the intervention ]
    standardized test to assess fine motor skills

  18. Box-and-Block Test [ Time Frame: 90±20 days after the intervention ]
    standardized test to assess fine motor skills

  19. Box-and-Block Test [ Time Frame: 12±1 months after the intervention ]
    standardized test to assess fine motor skills

  20. Grip Force [ Time Frame: 1-7 days after the end of the intervention ]
    dynamometer-based test to assess grip strength

  21. Grip Force [ Time Frame: 30±10 days after the intervention ]
    dynamometer-based test to assess grip strength

  22. Grip Force [ Time Frame: 90±20 days after the intervention ]
    dynamometer-based test to assess grip strength

  23. Grip Force [ Time Frame: 12±1 months after the intervention ]
    dynamometer-based test to assess grip strength



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909714


Locations
Layout table for location information
Austria
Neurologische Universitätsklinik Wien
Wien, Austria, 1090
Germany
Klinik Kipfenberg
Kipfenberg, Bayern, Germany, 85110
Brandenburgklinik Berlin-Brandenburg
Bernau bei Berlin, Berlin, Germany, 16321
Neurologie Moritzklinik
Bad Klosterlausnitz, Thüringen, Germany, 07639
Neurologische Klinik Bad Aibling
Bad Aibling, Germany, 83043
Neurologisches Zentrum Segeberger Kliniken
Bad Segeberg, Germany, 23795
NRZ Leipzig
Bennewitz, Germany, 04828
MEDIAN Klinik Berlin-Kladow
Berlin, Germany, 14089
University Medical Center Hamburg Eppendorf (UKE)
Hamburg, Germany, 20246
University Medical Center Heidelberg
Heidelberg, Germany, 69120
Italy
Fondazione Santa Lucia
Rome, Italy, 00179
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Layout table for investigator information
Principal Investigator: Christian Gerloff, Prof. Dr. Department of Neurology, University Medical Center Hamburg-Eppendorf
Publications:

Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00909714    
Other Study ID Numbers: NETS Trial
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing is planned after main publication of results.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Within 24 months after main publication.
Access Criteria: Personal login into UKE data repository.
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stroke
non-invasive cortical stimulation
motor recovery
cortical plasticity
TDCS
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases