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

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ClinicalTrials.gov Identifier: NCT00909714
Recruitment Status : Recruiting
First Posted : May 28, 2009
Last Update Posted : August 31, 2018
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.


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 : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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 day after the end of the 2-weeks intervention ]
    standardized test of upper extremity function


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

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

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

  4. Action Research Arm Test (ARAT) [ Time Frame: 1 day after the end of the 2-weeks intervention ]
    standardized tests of upper extremity function

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

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

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

  8. Nine Hole Peg Test (NHPT) [ Time Frame: 1 day after the end of the 2-weeks intervention ]
    standardized test to assess fine motor skills

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

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

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

  12. Stroke Impact Scale (SIS) [ Time Frame: 1 day after the end of the 2-weeks intervention ]
    questionnaire is to evaluate how stroke has impacted health and life of patients

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



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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 motoric 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


Contacts
Contact: Christian Gerloff, Prof. Dr. +49(0)40 741053770 gerloff@uke.de
Contact: Silke Wolf, MSc +49(0)40 741053770 si.wolf@uke.de

Locations
Germany
Brandenburgklinik Berlin-Brandenburg Recruiting
Bernau bei Berlin, Berlin, Germany, 16321
Contact: Michael Jöbges, Prof. Dr.    +49(0)333973400    joebges@brandenburgklinik.de   
Neurologische Klinik Bad Aibling Recruiting
Bad Aibling, Germany, 83043
Contact: Jürgen Dressnandt, Dr.    +49(0)80619031510    jdressnandt@Schoen-Kliniken.de   
Contact: Barbara Schäpers    +49(0)80619031952    bschaepers@schoen-kliniken.de   
Neurologisches Zentrum Segeberger Kliniken Recruiting
Bad Segeberg, Germany, 23795
Contact: Björn Hauptmann, Dr.    +49(0)45518026853    bjoern.hauptmann@segebergerkliniken.de   
NRZ Leipzig Recruiting
Bennewitz, Germany, 04828
Contact: Caroline Renner, PD Dr.    +49(0)3434531900    renner@sachsenklinik.de   
MEDIAN Klinik Berlin-Kladow Recruiting
Berlin, Germany, 14089
Contact: Christian Dohle, Dr.    +49(0)3036503102    christian.dohle@median-kliniken.de   
University Medical Center Hamburg Eppendorf (UKE) Recruiting
Hamburg, Germany, 20246
Contact: Robert Schulz, Dr.    +49(0)40741053770    r.schulz@uke.de   
Contact: Julia Hoppe, Dr.    +49(0)40741053770    j.hoppe@uke.de   
University Medical Center Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Alexander Gutschalk, Prof. Dr.    +49(0)6221567504    Alexander.Gutschalk@med.uni-heidelberg.de   
Italy
Fondazione Santa Lucia Recruiting
Rome, Italy, 00179
Contact: Giacomo Koch, Prof. Dr.    +39(0)651501181    giakoch@gmail.com   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Christian Gerloff, Prof. Dr. Department of Neurology, University Medical Center Hamburg-Eppendorf

Publications:

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00909714     History of Changes
Other Study ID Numbers: NETS Trial
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stroke
non-invasive cortical stimulation
motor recovery
cortical plasticity
TDCS

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases