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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf Identifier:
First received: May 12, 2009
Last updated: September 13, 2016
Last verified: September 2016
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 Intervention
Device: DC-Stimulator to apply tDCS or Sham tDCS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuroregeneration Enhanced by TDCS in Stroke

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Upper Extremity Fugl-Meyer-Assessment (UEFMA) [ Time Frame: 12 months after the intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Jebsen-Taylor Test (JTT), Action Research Arm Test (ARAT), Nine Hole Peg Test (NHPT), Stroke Impact Scale (SIS), UEFMA [ Time Frame: 12 months after the intervention (day11, 40, 100, 190 after intervention) ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2009
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tDCS
DC-Stimulator to apply tDCS + Training
Device: DC-Stimulator to apply tDCS or Sham tDCS
Anodal tDCS (20 minutes) or Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training
Sham Comparator: Sham tDCS
DC-Stimulator to apply Sham tDCS (Placebo) + Training
Device: DC-Stimulator to apply tDCS or Sham tDCS
Anodal tDCS (20 minutes) or Sham stimulation will be applied once a day in combination with standardized upper extremity rehabilitative training

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subacute stroke patients (5-21 days after stroke, age>18 years) with thromboembolic non-hemorrhagic subcortical or cortical first-ever strokes will be included. Moderate to moderately severe upper-extremity hemiparesis, defined as an Upper Extremity Fugl-Meyer score (UEFMA) between 28 and 50 (inclusive).

Exclusion Criteria:

  • more than one stroke
  • progressive stroke
  • completely lesioned hand knob area of M1affected or cerebellar lesions
  • history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, or with serious cognitive deficits
  • severe uncontrolled medical problems
  • rheumatological or traumatic diseases affecting the upper extremities
  • other neurological diseases
  • severe microangiopathy, polyneuropathy, ischemic peripheral disease
  • pregnancy
  • contraindication for MRI or TMS
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00909714

Contact: Christian Gerloff, Prof. Dr. +49(0)40 741053770
Contact: Robert Schulz, Dr. +49(0)40 741053770

Universitätsklinik für Neurologie Wien Not yet recruiting
Wien, Austria
Contact: Seidel, MD         
Neurologische Klinik Bad Aibling Recruiting
Bad Aibling, Germany
Contact: E. Koenig, MD         
Contact: Dressnandt, MD         
Moritz-Klinik Bad Klosterlausnitz Recruiting
Bad Klosterlausnitz, Germany, 07639
Contact: Farsin Hamzei, MD         
Neurologisches Zentrum Segeberger Kliniken Recruiting
Bad Segeberg, Germany
Contact: Valdueza, MD         
Contact: B. Hauptmann, MD         
Department of Neurology, University of Berlin Not yet recruiting
Berlin, Germany
Contact: A Floel, MD         
Department of Neurology Recruiting
Hamburg, Germany, 20246
Contact: Robert Schulz, Dr.    +49 (0)40 7410 53770   
Contact: Julia Hoppe, Dr.    +49 (0)40 7410 53770   
Neurologische Fachklinik Kipfenberg Recruiting
Kipfenberg, Germany, 85110
Contact: Dennis Nowak, MD         
St. Mauritius Therapieklinik Meerbusch Recruiting
Meerbusch, Germany
Contact: Hömberg, MD         
Contact: Stephan, MD         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Principal Investigator: Christian Gerloff, Prof. Dr. Department of Neurology, University Medical Center Hamburg-Eppendorf
  More Information

Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT00909714     History of Changes
Other Study ID Numbers: NETS Trial 
Study First Received: May 12, 2009
Last Updated: September 13, 2016
Health Authority: Germany: Ethics Commission
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases processed this record on September 23, 2016