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

This study is currently recruiting participants.
Verified November 2012 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00909714
First received: May 12, 2009
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Subacute Stroke
 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 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tDCS
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909714

Contacts
Contact: Friedhelm Hummel, Dr. +49(0)40 741053772 f.hummel@uke.uni-hamburg.de
Contact: Christian Gerloff, Prof. Dr. +49(0)40 741053772 gerloff@uke.uni-hamburg.de

Locations
Austria
Universitätsklinik für Neurologie Wien Not yet recruiting
Wien, Austria
Contact: Seidel, MD            
France
Service de Médecine Physique et Réadaptation, Hôpital Bellevue Not yet recruiting
CHU de Saint-Etienne, France
Contact: P. Giraux, MD            
Service de Médecine Physique et Réadaptation, Hôpital Pitié-Salpétrière Not yet recruiting
Pitié-Salpétrière, France
Contact: D. Mazevet, MD            
Médecine Physique et de Réadaptation, Pôle Locomoteur Hôpital Rangueil Not yet recruiting
Toulouse, France
Contact: P. Marqué, MD            
Germany
Neurologische Klinik Bad Aibling Recruiting
Bad Aibling, Germany
Contact: E. Koenig, MD            
Contact: Dressnandt, MD            
Moritz-Klinik Bad Klosterlausnitz Not yet 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, University of Freiburg Not yet recruiting
Freiburg, Germany
Contact: Janine Reis, MD            
Contact: Hamzei, MD            
Department of Neurology Recruiting
Hamburg, Germany, 20246
Contact: Friedhelm Hummel, Dr.     +49 (0)40 7410 53772     f.hummel@uke.uni-hamburg.de    
Neurologische Fachklinik Kipfenberg Recruiting
Kipfenberg, Germany, 85110
Contact: Dennis Nowak, MD            
St. Mauritius Therapieklinik Meerbusch Recruiting
Meerbusch, Germany
Contact: Hömberg, MD            
Contact: Stephan, MD            
Switzerland
Department of Neurology, University Zürich Not yet recruiting
Zürich, Switzerland
Contact: M. Weller, MD            
Contact: Luft, MD            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Christian Gerloff, Prof. Dr. Department of Neurology, University Medical Center Hamburg-Eppendorf
Principal Investigator: Friedhelm C Hummel, MD Department of Neurology, University Medical Center Hamburg-Eppendorf
  More Information

Publications:

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00909714     History of Changes
Other Study ID Numbers: NETS Trial
Study First Received: May 12, 2009
Last Updated: November 2, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 23, 2013