Neuroregeneration Enhanced by Transcranial Direct Current Stimulation (TDCS) in Stroke - Full Text View

Sponsor:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00909714

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:	August 2012
Estimated Primary Completion Date:	July 2012 (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:

Hummel FC, Cohen LG. Non-invasive brain stimulation: a new strategy to improve neurorehabilitation after stroke? Lancet Neurol. 2006 Aug;5(8):708-12. Review.

Hummel F, Celnik P, Giraux P, Floel A, Wu WH, Gerloff C, Cohen LG. Effects of non-invasive cortical stimulation on skilled motor function in chronic stroke. Brain. 2005 Mar;128(Pt 3):490-9. Epub 2005 Jan 5.

Responsible Party:	Prof. Dr. med. Christian Gerloff, University Medical Center Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00909714 History of Changes
Other Study ID Numbers:	NETS Trial
Study First Received:	May 12, 2009
Last Updated:	July 22, 2011
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 February 02, 2012