Enhancement of Motor Function With Reboxetine and Transcranial Direct Current Stimulation (STIMBOX)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
German Research Foundation
University Hospital Tuebingen
Information provided by:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT00853866
First received: February 27, 2009
Last updated: December 1, 2010
Last verified: December 2010
  Purpose

The hypothesis of the study is that combination of reboxetine/tDCS is more effective in enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to reboxetine and tDCS alone. The protocol is designed as a within-subject, block randomized placebo-controlled double-blind crossover study.


Condition Intervention Phase
Cerebral Stroke
Drug: reboxetine
Drug: Placebo
Device: tDCS verum
Device: tDCS sham
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Entwicklung Neuronaler Repräsentationen Nach Schlaganfall: Verbesserung Motorischer Leistungen Durch Transkranielle Gleichstromstimulation Und Noradrenerge Co-Stimulation

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • Jebsen Taylor test [ Time Frame: crossover design, four different sessions with four different interventions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maximum grip force [ Time Frame: crossover design, four different sessions with four different interventions ] [ Designated as safety issue: No ]
  • nine hole peg test [ Time Frame: crossover design, four different sessions with four different interventions ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
reboxetine + tDCS verum
Drug: reboxetine
single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
Other Name: brand name: Edronax, serial number: KPR 08092410/11
Device: tDCS verum
20 minutes of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
Other Names:
  • Hersteller:
  • DC Stimulator
  • Manufacturer:
  • eldith -Electro-Diagnostic & Therapeutic Systems GmbH
  • Gustav-Kirchhoff-Straße 5
  • D-98693 Ilmenau
  • Serialnumber: 0006
Experimental: 2
reboxetine + sham tDCS
Drug: reboxetine
single dose of 4mg reboxetine 80 minutes before assessment of Jebsen Taylor test
Other Name: brand name: Edronax, serial number: KPR 08092410/11
Device: tDCS sham
30 seconds of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
Other Names:
  • Hersteller:
  • DC Stimulator
  • Manufacturer:
  • eldith -Electro-Diagnostic & Therapeutic Systems GmbH
  • Gustav-Kirchhoff-Straße 5
  • D-98693 Ilmenau
  • Serialnumber: 0006
Experimental: 3
placebo drug + verum tDCS
Drug: Placebo
placebo, 80 min before assessment of Jebsen Taylor test
Device: tDCS verum
20 minutes of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
Other Names:
  • Hersteller:
  • DC Stimulator
  • Manufacturer:
  • eldith -Electro-Diagnostic & Therapeutic Systems GmbH
  • Gustav-Kirchhoff-Straße 5
  • D-98693 Ilmenau
  • Serialnumber: 0006
Experimental: 4
placebo drug + sham tDCS
Drug: Placebo
placebo, 80 min before assessment of Jebsen Taylor test
Device: tDCS sham
30 seconds of 1 mV transcranial direct current stimulation with 5x5 cm electrodes with active electrode over the primary motor representation of the stroke hemisphere and reference electrode over the contralateral supraorbital area Application during assessment of Jebsen Taylor test
Other Names:
  • Hersteller:
  • DC Stimulator
  • Manufacturer:
  • eldith -Electro-Diagnostic & Therapeutic Systems GmbH
  • Gustav-Kirchhoff-Straße 5
  • D-98693 Ilmenau
  • Serialnumber: 0006

Detailed Description:

One important feature of the human brain is the ability to undergo plastic changes and reorganization after learning and lesions of the nervous system. This ability is of major importance for the treatment of functional deficits after stroke. Stroke is the major disease leading to persistent functional disabilities in Germany. However, the success rate of therapeutic interventions, especially in chronic stroke patients, is still unsatisfactory. Thus, basic science is essential to discover new therapeutic options that bear the potential for translation into clinical practice. Recent evidence is pointing to modulating the motor cortical excitability in order to enhance motor function in stroke patients. For this purpose, reboxetine as a selective reuptake inhibitor of noradrenaline and transcranial direct current stimulation have proven effective in enhancing motor functions needed for daily life activities by 10-12%. These improvements were significant compared to placebo, but still clinically unsatisfactory. Thus, this protocol aims at enhancing the excitability modulatory effect of each single intervention through the combination of reboxetine and tDCS. The hypothesis of the study is that combination of reboxetine/tDCS is more effective in enhancing motor functions of daily life (assessed by the Jebsen Taylor test) as compared to reboxetine and tDCS alone.

The protocol is designed as a within-subject, block randomized placebo-controlled double-blind crossover study. 12 chronic stroke patients with persistent functional deficits of the arm and/or hand will be included. The primary outcome measure is the time needed to fulfill all subtests of the Jebsen Taylor test. All patients undergo four different conditions in four different sessions: 1) reboxetine + verum tDCS; 2) reboxetine + sham tDCS 3) placebo drug + verum tDCS 4) placebo drug + sham tDCS.

  Eligibility

Ages Eligible for Study:   18 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age between 18 and 86
  • patient is contractually capable
  • first-ever, ischemic stroke
  • minimum time since stroke 9 months
  • a paresis of the arm/hand muscles above 3 on the MRC scale

Exclusion Criteria:

  • multiple cerebral lesions and associated residual deficits
  • severe head trauma in the past
  • seizures
  • ferromagnetic implants in the head/neck region
  • pacemaker
  • a psychiatric disorder or neurological disease besides stroke
  • intake of illegal drugs
  • severe aphasia or cognitive deficits that impede contractual capability
  • contraindications for reboxetine (seizures, glaucoma, prostate hyperplasia with urinary retention, cardiac arrhythmias, potential interactions with co-medication)
  • pregnancy
  • breast-feeding patients
  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 ClinicalTrials.gov identifier: NCT00853866

Contacts
Contact: Gianpiero Liuzzi, MD +49 40 7410 ext 59278 g.liuzzi@uke.de
Contact: Christian Gerloff, MD + 49 40 7410 ext 53770 gerloff@uke.de

Locations
Germany
University Hospital Hamburg-Eppendorf, Department of Neurology Recruiting
Hamburg, HH, Germany, 20246
Contact: Gianpiero Liuzzi, MD    +49 40 7410 ext 59278    g.liuzzi@uke.de   
Contact: Christian Gerloff, MD    +49 40 7410 ext 53770    gerloff@uke.de   
Sub-Investigator: Gianpiero Liuzzi, MD         
Principal Investigator: Christian Gerloff, MD         
Sub-Investigator: Julia Hoppe, MD         
Sub-Investigator: Friedhelm C Hummel, MD         
Sub-Investigator: Kirstin F Heise, MSc         
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
German Research Foundation
University Hospital Tuebingen
Investigators
Principal Investigator: Christian Gerloff, MD Department of Neurology, University Hospital Hamburg-Eppendorf
  More Information

Additional Information:
Publications:
Responsible Party: Prof. Dr. C. Gerloff, Department of Neurology, University Hospital Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00853866     History of Changes
Other Study ID Numbers: 2005-00160436-36, 28/2005AMG1, IMPACS-01
Study First Received: February 27, 2009
Last Updated: December 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
stroke
reboxetine
noradrenaline
motor cortex
transcranial direct current stimulation
motor function
rehabilitation
Jebsen Taylor test

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Reboxetine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014